45 results on '"Mengardo V"'
Search Results
2. Tailored treatment for signet ring cell gastric cancer
- Author
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Mengardo, V., Treppiedi, E., Bencivenga, M., Dal Cero, Mariagiulia, and Giacopuzzi, S.
- Published
- 2018
- Full Text
- View/download PDF
3. Acute bleeding obstruction pancreatitis after Roux-en-Y anastomosis in total gastrectomy: a single center experience
- Author
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Weindelmayer, J., Laiti, S., La Mendola, R., Bencivenga, M., Scorsone, L., Mengardo, V., and Giacopuzzi, S.
- Published
- 2018
- Full Text
- View/download PDF
4. Current practice on the use of prophylactic drain after gastrectomy in Italy: the Abdominal Drain in Gastrectomy (ADiGe) survey
- Author
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Mengardo, V, Weindelmayer, J, Veltri, A, Giacopuzzi, S, Torroni, L, de Manzoni, G, Agresta, F, Alfieri, R, Alfieri, S, Antonacci, N, Baiocchi, G, Bencini, L, Bencivenga, M, Benedetti, M, Berselli, M, Biondi, A, Capolupo, G, Carboni, F, Casadei, R, Casella, F, Catarci, M, Cerri, P, Chiari, D, Cocozza, E, Colombo, G, Cozzaglio, L, Dalmonte, G, Degiuli, M, De Luca, M, De Luca, R, De Manzini, N, De Pasqual, C, De Pascale, S, De Ruvo, N, Di Cosmo, M, Di Leo, A, Di Paola, M, Elio, A, Ferrara, F, Ferrari, G, Fiscon, V, Fumagalli, U, Garulli, G, Gennai, A, Gentile, I, Germani, P, Gualtierotti, M, Guerini, F, Gurrado, A, Inama, M, La Torre, F, Laterza, E, Losurdo, P, Macri, A, Marano, A, Marano, L, Marchesi, F, Marino, F, Massani, M, Menghi, R, Milone, M, Molfino, S, Montuori, M, Moretto, G, Morgagni, P, Morpurgo, E, Abdallah, M, Nespoli, L, Olmi, S, Palaia, R, Pallabazer, G, Parise, P, Pasculli, A, Pericoli Ridolfini, M, Pesce, A, Pinotti, E, Pisano, M, Poiasina, E, Postiglione, V, Rausei, S, Rella, A, Rosa, F, Rosati, R, Rossi, G, Rossit, L, Rovatti, M, Ruspi, L, Sacco, L, Saladino, E, Sansonetti, A, Sartori, A, Scaglione, D, Scaringi, S, Schoenthaler, C, Sena, G, Simone, M, Solaini, L, Strignano, P, Tartaglia, N, Testa, S, Testini, M, Tiberio, G, Treppiedi, E, Vagliasindi, A, Valmasoni, M, Vigano, J, Zanchettin, G, Zanoni, A, Zardini, C, Zerbinati, A, Mengardo V., Weindelmayer J., Veltri A., Giacopuzzi S., Torroni L., de Manzoni G., Agresta F., Alfieri R., Alfieri S., Antonacci N., Baiocchi G. L., Bencini L., Bencivenga M., Benedetti M., Berselli M., Biondi A., Capolupo G. T., Carboni F., Casadei R., Casella F., Catarci M., Cerri P., Chiari D., Cocozza E., Colombo G., Cozzaglio L., Dalmonte G., Degiuli M., De Luca M., De Luca R., De Manzini N., De Pasqual C. A., De Pascale S., De Ruvo N., Di Cosmo M., Di Leo A., Di Paola M., Elio A., Ferrara F., Ferrari G., Fiscon V., Fumagalli U., Garulli G., Gennai A., Gentile I., Germani P., Gualtierotti M., Guerini F., Gurrado A., Inama M., La Torre F., Laterza E., Losurdo P., Macri A., Marano A., Marano L., Marchesi F., Marino F., Massani M., Menghi R., Milone M., Molfino S., Montuori M., Moretto G., Morgagni P., Morpurgo E., Abdallah M., Nespoli L., Olmi S., Palaia R., Pallabazer G., Parise P., Pasculli A., Pericoli Ridolfini M., Pesce A., Pinotti E., Pisano M., Poiasina E., Postiglione V., Rausei S., Rella A., Rosa F., Rosati R., Rossi G., Rossit L., Rovatti M., Ruspi L., Sacco L., Saladino E., Sansonetti A., Sartori A., Scaglione D., Scaringi S., Schoenthaler C., Sena G., Simone M., Solaini L., Strignano P., Tartaglia N., Testa S., Testini M., Tiberio G. A. M., Treppiedi E., Vagliasindi A., Valmasoni M., Vigano J., Zanchettin G., Zanoni A., Zardini C., Zerbinati A., Mengardo, V, Weindelmayer, J, Veltri, A, Giacopuzzi, S, Torroni, L, de Manzoni, G, Agresta, F, Alfieri, R, Alfieri, S, Antonacci, N, Baiocchi, G, Bencini, L, Bencivenga, M, Benedetti, M, Berselli, M, Biondi, A, Capolupo, G, Carboni, F, Casadei, R, Casella, F, Catarci, M, Cerri, P, Chiari, D, Cocozza, E, Colombo, G, Cozzaglio, L, Dalmonte, G, Degiuli, M, De Luca, M, De Luca, R, De Manzini, N, De Pasqual, C, De Pascale, S, De Ruvo, N, Di Cosmo, M, Di Leo, A, Di Paola, M, Elio, A, Ferrara, F, Ferrari, G, Fiscon, V, Fumagalli, U, Garulli, G, Gennai, A, Gentile, I, Germani, P, Gualtierotti, M, Guerini, F, Gurrado, A, Inama, M, La Torre, F, Laterza, E, Losurdo, P, Macri, A, Marano, A, Marano, L, Marchesi, F, Marino, F, Massani, M, Menghi, R, Milone, M, Molfino, S, Montuori, M, Moretto, G, Morgagni, P, Morpurgo, E, Abdallah, M, Nespoli, L, Olmi, S, Palaia, R, Pallabazer, G, Parise, P, Pasculli, A, Pericoli Ridolfini, M, Pesce, A, Pinotti, E, Pisano, M, Poiasina, E, Postiglione, V, Rausei, S, Rella, A, Rosa, F, Rosati, R, Rossi, G, Rossit, L, Rovatti, M, Ruspi, L, Sacco, L, Saladino, E, Sansonetti, A, Sartori, A, Scaglione, D, Scaringi, S, Schoenthaler, C, Sena, G, Simone, M, Solaini, L, Strignano, P, Tartaglia, N, Testa, S, Testini, M, Tiberio, G, Treppiedi, E, Vagliasindi, A, Valmasoni, M, Vigano, J, Zanchettin, G, Zanoni, A, Zardini, C, Zerbinati, A, Mengardo V., Weindelmayer J., Veltri A., Giacopuzzi S., Torroni L., de Manzoni G., Agresta F., Alfieri R., Alfieri S., Antonacci N., Baiocchi G. L., Bencini L., Bencivenga M., Benedetti M., Berselli M., Biondi A., Capolupo G. T., Carboni F., Casadei R., Casella F., Catarci M., Cerri P., Chiari D., Cocozza E., Colombo G., Cozzaglio L., Dalmonte G., Degiuli M., De Luca M., De Luca R., De Manzini N., De Pasqual C. A., De Pascale S., De Ruvo N., Di Cosmo M., Di Leo A., Di Paola M., Elio A., Ferrara F., Ferrari G., Fiscon V., Fumagalli U., Garulli G., Gennai A., Gentile I., Germani P., Gualtierotti M., Guerini F., Gurrado A., Inama M., La Torre F., Laterza E., Losurdo P., Macri A., Marano A., Marano L., Marchesi F., Marino F., Massani M., Menghi R., Milone M., Molfino S., Montuori M., Moretto G., Morgagni P., Morpurgo E., Abdallah M., Nespoli L., Olmi S., Palaia R., Pallabazer G., Parise P., Pasculli A., Pericoli Ridolfini M., Pesce A., Pinotti E., Pisano M., Poiasina E., Postiglione V., Rausei S., Rella A., Rosa F., Rosati R., Rossi G., Rossit L., Rovatti M., Ruspi L., Sacco L., Saladino E., Sansonetti A., Sartori A., Scaglione D., Scaringi S., Schoenthaler C., Sena G., Simone M., Solaini L., Strignano P., Tartaglia N., Testa S., Testini M., Tiberio G. A. M., Treppiedi E., Vagliasindi A., Valmasoni M., Vigano J., Zanchettin G., Zanoni A., Zardini C., and Zerbinati A.
- Abstract
Evidence against the use of prophylactic drain after gastrectomy are increasing and ERAS guidelines suggest the benefit of drain avoidance. Nevertheless, it is unclear whether this practice is still widespread. We conducted a survey among Italian surgeons through the Italian Gastric Cancer Research Group and the Polispecialistic Society of Young Surgeons, aiming to understand the current use of prophylactic drain. A 28-item questionnaire-based survey was developed to analyze the current practice and the individual opinion about the use of prophylactic drain after gastrectomy. Groups based on age, experience and unit volume were separately analyzed. Response of 104 surgeons from 73 surgical units were collected. A standardized ERAS protocol for gastrectomy was applied by 42% of the respondents. Most of the surgeons, regardless of age, experience, or unit volume, declared to routinely place one or more drain after gastrectomy. Only 2 (1.9%) and 7 surgeons (6.7%) belonging to high volume units, do not routinely place drains after total and subtotal gastrectomy, respectively. More than 60% of the participants remove the drain on postoperative day 4–6 after performing an assessment of the anastomosis integrity. Interestingly, less than half of the surgeons believe that drain is the main tool for leak management, and this percentage further drops among younger surgeons. On the other hand, drain’s role seems to be more defined for duodenal stump leak treatment, with almost 50% of the surgeons recognizing its importance. Routine use of prophylactic drain after gastrectomy is still a widespread practice even if younger surgeons are more persuaded that it could not be advantageous.
- Published
- 2022
5. 33: A SNAPSHOT OF THE CURRENT PRACTICE ON THE USE OF PROPHYLACTIC DRAIN AFTER GASTRECTOMY IN ITALY: THE ABDOMINAL DRAIN IN GASTRECTOMY (ADIGE) SURVEY
- Author
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Mengardo, V, primary, Weindelmayer, J, additional, Torroni, L, additional, Veltri, A, additional, and De Manzoni, G, additional
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- 2022
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6. 31: UTILITY OF ABDOMINAL DRAIN IN GASTRECTOMY (ADIGE) TRIAL: STUDY PROTOCOL FOR A MULTICENTER NON-INFERIORITY RANDOMIZED TRIAL
- Author
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Weindelmayer, J, primary, Mengardo, V, additional, Veltri, A, additional, Baiocchi, G L, additional, Giacopuzzi, S, additional, Verlato, G, additional, and De Manzoni, G, additional
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- 2022
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7. 32: ENHANCED RECOVERY AFTER SURGERY CAN IMPROVE PATIENTS’ OUTCOMES AND REDUCE HOSPITAL COST OF GASTRECTOMY FOR CANCER IN THE WEST. A PROPENSITY SCORE-BASED ANALYSIS
- Author
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Weindelmayer, J, primary, Mengardo, V, additional, Gasparini, A, additional, Sacco, M, additional, Torroni, L, additional, Carlini, M, additional, Verlato, G, additional, and De Manzoni, G, additional
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- 2022
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8. Correlation between 18F-FDG PET-CT metrics and the pathological response in esophageal cancer treated with induction chemotherapy followed by neoadjuvant chemoradiotherapy: conventional and radiomic features
- Author
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Guariglia, S., primary, Zivelonghi, E., additional, Simoni, N., additional, Rossi, G., additional, Benetti, G., additional, Micera, R., additional, Pavarana, M., additional, Mengardo, V., additional, Weindelmayer, J., additional, Giacopuzzi, S., additional, De Manzoni, G., additional, Zuffante, M., additional, Mazzarotto, R., additional, and Cavedon, C., additional
- Published
- 2021
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9. Core Outcome Set for Surgical Trials in Gastric Cancer (GASTROS Study):International patient and healthcare professional consensus
- Author
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Alkhaffaf, B, Metryka, A, Blazeby, J M, Glenny, A-M, Adeyeye, A, Costa, P M, Diez Del Val, I, Gisbertz, S S, Guner, A, Law, S, Lee, H-J, Li, Z, Nakada, K, Reim, D, Vorwald, P, Baiocchi, G L, Allum, W, Chaudry, M A, Griffiths, E A, Williamson, P R, Bruce, I A, Li, S., He, Yl, Xu, Z., Xue, Y., Liang, H., Li, G., Zhao, E., Neumann, P., O’Neill, L., Guinan, E., Zanotti, D., de Manzoni, G., Hagens, Erc., van Berge Henegouwen, Mi., Lages, P., Onofre, S., Restrepo Nunez, Rm., Salcedo Cabanas, G., Posada Gonzalez, M., Marin Campos, C., Candas, B., Emre Baki, B., Selim Bodur, M., Yildirim, R., Burak Cekic, A., Brown, J., Hayes, K., Daher, I., Gianchandani Moorjani, Rh., Adetoyese Adeyeye, A., Sulaiman Olayide, A., Mitsuo Leon-Takahashi, A., Pueyo Rabanal, A., Peri, A., Boddy, A., Novotny, A., Charalabopoulos, A., Alemdar, A., Souadka, A., Rodrigues Gomes, Am., Lazaro, A., Maciel Da Silva, A., do Rosario da Conceicao Silva e Santos, A., Guidi, A., Silva Bernardes, Aj., Quinn, A., Isik, A., A Slipek, A., Candas Altinbas, B., Johnson Alegbeleye, B., Wool Eom, B., Frittoli, B., Lonsdale, B., Rogers, B., Ammori, Bj., Rau, B., Molteni, B., Byrne, Be., Villacıs- Bermeo, Ba., Villacıs Gallardo, Be., Kose, B., Sampedro Nogueira, Cj., Loureiro, C., Oliveira de Sousa, Cm., Collins, Cg., Nonso Ekwunife, C., Chukwunwendu Osuagwu, C., Wong, Cly., Winkler, C., Reim, D., Kjær, Dw., Cooper, D., Horner, D., Irvine, D., Bowrey, Dj., Chuter, Dj., Elliot, D., Mcghee, D., Toth, D., Ofner, D., Manatakis, Dk., Silveira Martins, Dr., Belt, Ejt., Cattaneo, E., Samadov, E., Colak, E., Treppiedi, E., Guglielmi, E., Redondo- Villahoz, E., Ciferri, E., Tiemens-de Graaf, E., Cocozza, E., Pape, E., Drozdov, Es., Enrico, F., Rashid, F., Sandri, Marco, Rosa, F., Mingol Navarro, F., Simionato Perrotta, F., Chan, Fsy., Saavedra Tomasich, Fd., Takeda, Fr., Farrell, F., Olanike Wuraola, F., Rosero, G., Bevilacqua, G., Baronio, G., Mura, G., D’Eugenio, G., Ortega-Perez, G., Tilt, G., Sutcliffe, G., Mureddu, G., Guerra Jacob, G., Daneri, H., Olufemi Gbenga, H., Okabe, H., Kingsford Smith, I., Olawale Lateef, I., Garosio, I., Hatipoglu, I., Gockel, I., Negoi, I., Min, Ish., Mesquita, Imm., Diez del Val, I., Leemhuis, Jhf., Gossage, Ja., Weindelmayer, J., Izbicki, Jr., McKenzie Manson, J., Kelly, J., Stoot, Jhmb., Haveman, Jw., Brown, Jd., Sultan, J., Hassall, J., van Sandick, J., Saunders, Jh., Clarke, Jk., Heisterkamp, J., Vargas, Ji., Couselo Villanueva, Jm., Ingmire, J., Mcewen, J., Galindo Alvarez, J., Turner, J., Peng, J., Roberts, K., Brandon, Kg., Mitchell, K., Mccarthy, K., Akhtar, K., Mikhailovich, Kn., Corbelli, L., Medeiros Milhomem, L., Solaini, L., Fengyuan, L., Xinchun, L., Timmermans, L., Porritt, L., Taglietti, L., Bonavina, L., F. Pinheiro L., de los Angeles Mayo Ossorio, M., Schiavo, M., Marchesiello, M., das Dores Vieira Leite, M., Demois, M., Di Felice, Mt., de Sousa, Md., Takahashi, M., Forshaw, M., Berselli, M., Paro, M., Usta, Ma., Yan, Mh., Pinchin, M., Caprioli, M., Rubbini, M., Cowen, M., Herrera Servin, Ma., Li, Mz., Sasako, M., Shukri Jahit, M., Ngonyoku Muhinga, M., Tareen, Ma., Ahmad, Mf., Bodur, Ms., Kaban, M., Farooq, N., Coburn, N., Cooper, N., Blencowe, Ns., Loria, N., de Vries, N., Adami Andreollo, N., Koksal, N., Zanini, N., Kreuser, N., Okkabaz, N., Damiana, O., Afuwape, O., Kayode Fasiku, O., Comensoli, O., F. Koroye O., Capener, P., Morgagni, P., Pernadas Lages, Pm., Wilkerson, Pm., Turner, P., Dutton, P., Hayes, P., Vorwald, P., Singh, P., Gan, Q., Kottayasamy Seenivasagam, R., Ayloor Seshadri, R., Guevara Castro, R., Douglas, R., Koshy, Rm., Yıldırım, R., Skipworth, Rje., Gould, Ra., Wetherill, Rc., Shaw, R., Burley, Ra., Palatucci, R., Racalbuto, R., Correia Casaca, Rm., Lagarde, Sm., Gana, S., Marietti, S., Qureshi, S., Morales-Conde, S., Molfino, S., Barreto, Sg., Turkyilmaz, S., Turan-Trabzon, S., Frisch, S., Castoldi, S., Belloni, S., Flisi, S., Galloway, S., Maria, Sr., Royston, S., Boyle, T., Sezer, T., Mengardo, V., Concepcion Martın, V., Lee Wills, V., Owen-Holt, V., Casagrande, V., Al-Khyatt, W., Jansen, W., Wang, W., Eshuis, W., Polkowski, Wp., Huang, X., Wang, X., Chen, Xz., Gonzalez Dominguez, Y., Wang, Y., Viswanath, Yks., He, Yl., Demir, Z., Na, Z., Surgery, CCA - Cancer Treatment and Quality of Life, CCA - Cancer biology and immunology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, CCA - Imaging and biomarkers, Experimental Immunology, Clinical Immunology and Rheumatology, CCA -Cancer Center Amsterdam, and CCA - Cancer Treatment and quality of life
- Subjects
medicine.medical_specialty ,Manchester Cancer Research Centre ,business.industry ,gastric cancer ,ResearchInstitutes_Networks_Beacons/mcrc ,Delphi method ,MEDLINE ,Cancer ,medicine.disease ,Outcome (game theory) ,03 medical and health sciences ,0302 clinical medicine ,Quality of life (healthcare) ,030220 oncology & carcinogenesis ,Family medicine ,gastros ,Medicine ,Surgery ,030212 general & internal medicine ,Stage (cooking) ,Adverse effect ,business ,Set (psychology) - Abstract
Background Surgery is the primary treatment that can offer potential cure for gastric cancer, but is associated with significant risks. Identifying optimal surgical approaches should be based on comparing outcomes from well designed trials. Currently, trials report different outcomes, making synthesis of evidence difficult. To address this, the aim of this study was to develop a core outcome set (COS)—a standardized group of outcomes important to key international stakeholders—that should be reported by future trials in this field. Methods Stage 1 of the study involved identifying potentially important outcomes from previous trials and a series of patient interviews. Stage 2 involved patients and healthcare professionals prioritizing outcomes using a multilanguage international Delphi survey that informed an international consensus meeting at which the COS was finalized. Results Some 498 outcomes were identified from previously reported trials and patient interviews, and rationalized into 56 items presented in the Delphi survey. A total of 952 patients, surgeons, and nurses enrolled in round 1 of the survey, and 662 (70 per cent) completed round 2. Following the consensus meeting, eight outcomes were included in the COS: disease-free survival, disease-specific survival, surgery-related death, recurrence, completeness of tumour removal, overall quality of life, nutritional effects, and ‘serious’ adverse events. Conclusion A COS for surgical trials in gastric cancer has been developed with international patients and healthcare professionals. This is a minimum set of outcomes that is recommended to be used in all future trials in this field to improve trial design and synthesis of evidence.
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- 2021
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10. Association Between Compliance to an Enhanced Recovery Protocol and Outcome After Elective Surgery for Gastric Cancer. Results from a Western Population-Based Prospective Multicenter Study
- Author
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Gianotti, L, Fumagalli Romario, U, De Pascale, S, Weindelmayer, J, Mengardo, V, Sandini, M, Cossu, A, Parise, P, Rosati, R, Bencini, L, Coratti, A, Colombo, G, Galli, F, Rausei, S, Casella, F, Sansonetti, A, Maggioni, D, Costanzi, A, Bernasconi, D, De Manzoni, G, Gianotti L., Fumagalli Romario U., De Pascale S., Weindelmayer J., Mengardo V., Sandini M., Cossu A., Parise P., Rosati R., Bencini L., Coratti A., Colombo G., Galli F., Rausei S., Casella F., Sansonetti A., Maggioni D., Costanzi A., Bernasconi D. P., De Manzoni G., Gianotti, L, Fumagalli Romario, U, De Pascale, S, Weindelmayer, J, Mengardo, V, Sandini, M, Cossu, A, Parise, P, Rosati, R, Bencini, L, Coratti, A, Colombo, G, Galli, F, Rausei, S, Casella, F, Sansonetti, A, Maggioni, D, Costanzi, A, Bernasconi, D, De Manzoni, G, Gianotti L., Fumagalli Romario U., De Pascale S., Weindelmayer J., Mengardo V., Sandini M., Cossu A., Parise P., Rosati R., Bencini L., Coratti A., Colombo G., Galli F., Rausei S., Casella F., Sansonetti A., Maggioni D., Costanzi A., Bernasconi D. P., and De Manzoni G.
- Abstract
Background: The association between compliance to an enhanced recovery protocol (ERAS) and outcome after surgery for gastric cancer has been poorly investigated, particularly in Western patients. The aim of the study was to evaluate whether the rate of adherence to the ERAS program was correlated with outcome and time of discharge. Methods: A prospective, observational, multicenter study was designed to be performed at Italian referral centers for gastric surgery. The protocol was discussed and approved by the Italian Research Group on Gastric Cancer. Twenty-three ERAS domains were applied. A multivariate logistic regression was used to assess the association between ERAS compliance and overall and major complication rates. The Poisson regression model (measured as mean ratios) was used to assess the association of ERAS compliance rate and length of stay (LOS). Results: Eight centers participated and 290 subjects with a median age of 73 years were enrolled. The overall rates of adherence to pre-, intra-, and postoperative ERAS items were 69.8%, 60.3%, and 82.5%, respectively. At the multivariate model, there was an association between overall rate of morbidity and an overall ERAS compliance rate greater than 70% (OR 0.413; 95% CI 0.235–0.7240; P 0.002). A similar association was found for major complications (OR 0.328; 95% CI 0.151–0.709; P 0.005). The Poisson regression showed that in patients with ERAS compliance rate >70%, LOS was reduced of approximately 20% (mean ratio 0.812; 95% CI 0.694–0.950; P 0.009). Conclusions: These results suggest a moderate compliance to an ERAS program and a significant association between adherence and outcomes.
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- 2019
11. Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial
- Author
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Weindelmayer, J, Mengardo, V, Veltri, A, Baiocchi, G L, Giacopuzzi, S, Verlato, G, de Manzoni, G, and Italian Research Group for Gastric Cancer (GIRCG)
- Subjects
medicine.medical_specialty ,Percutaneous ,medicine.medical_treatment ,Medicine (miscellaneous) ,Anastomosis ,Abdominal drain ,Drainage ,Gastrectomy ,Gastric cancer ,Randomized controlled trial ,law.invention ,Study Protocol ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Meta-Analysis as Topic ,law ,Humans ,Multicenter Studies as Topic ,Medicine ,Pharmacology (medical) ,Cumulative incidence ,Prospective Studies ,Randomized Controlled Trials as Topic ,Retrospective Studies ,Protocol (science) ,lcsh:R5-920 ,business.industry ,Incidence (epidemiology) ,Retrospective cohort study ,Surgery ,030220 oncology & carcinogenesis ,030211 gastroenterology & hepatology ,lcsh:Medicine (General) ,business - Abstract
Background Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15 years, and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless, the authors evidenced the moderate/low quality of the included studies and highlighted how 3 out of 4 came from Eastern countries. After 2015, only retrospective studies have been published, all with inconsistent results. Methods ADiGe (Abdominal Drain in Gastrectomy) Trial is a multicenter prospective randomized non-inferiority trial with a parallel design. It aimed to verify whether avoiding routine use of abdominal drain is burdened with complications, particularly an increase in postoperative invasive procedures. Patients with gastric cancer, scheduled for subtotal or total gastrectomy with curative intent, are eligible for inclusion, irrespective of previous oncological treatment. The primary composite endpoint is reoperation or percutaneous drainage procedures within 30 postoperative days. The primary analysis will verify whether the incidence of the primary composite endpoint is higher in the experimental arm, avoiding routine drain placement, than control arm, undergoing prophylactic drain placement, in order to falsify or support the null hypothesis of inferiority. Secondary endpoints assessed for superiority are overall morbidity and mortality, Comprehensive Complications Index, incidence and time for diagnosis of anastomotic and duodenal leaks, length of hospital stay, and readmission rate. Assuming one-sided alpha of 5%, and cumulative incidence of the primary composite endpoint of 6.4% in the control arm and 4.2% in the experimental one, 364 patients allow to achieve 80% power to detect a non-inferiority margin difference between the arm proportions of 3.6%. Considering a 10% drop-out rate, 404 patients are needed. In order to have a balanced percentage between total and subtotal gastrectomy, recruitment will end at 202 patients for each type of gastrectomy. The surgeon and the patient are blinded until the end of the operation, while postoperative course is not blinded to the patient and caregivers. Discussion ADiGe Trial could contribute to critically re-evaluate the role of prophylactic drain in gastrectomy, a still widely used procedure. Trial registration Prospectively registered (last updated on 29 October 2020) at ClinicalTrials.gov with the identifier NCT04227951.
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- 2021
12. Lymphadenectomy for gastric cancer at European specialist centres
- Author
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Bencivenga, M., primary, Torroni, L., additional, Verlato, G., additional, Mengardo, V., additional, Sacco, M., additional, Allum, W.H., additional, and de Manzoni, G., additional
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- 2021
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13. Small type O-IIa de novo colon cancer treated with curative endoscopic full-thickness resection (EFTR)
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Catalano, F., primary, Cerofolini, A., additional, Mengardo, V., additional, Tomezzoli, A., additional, Borghini, R., additional, and Trecca, A., additional
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- 2020
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14. Is enhanced recovery protocol for gastric cancer feasible and safe in the west? A single center experience
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Weindelmayer, J., primary, Mengardo, V., additional, Gasparini, A., additional, Torroni, L., additional, Benedetti, B., additional, De Pasqual, C.A., additional, Verlato, G., additional, and de Manzoni, G., additional
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- 2019
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15. OD185 - Correlation between 18F-FDG PET-CT metrics and the pathological response in esophageal cancer treated with induction chemotherapy followed by neoadjuvant chemoradiotherapy: conventional and radiomic features
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Guariglia, S., Zivelonghi, E., Simoni, N., Rossi, G., Benetti, G., Micera, R., Pavarana, M., Mengardo, V., Weindelmayer, J., Giacopuzzi, S., De Manzoni, G., Zuffante, M., Mazzarotto, R., and Cavedon, C.
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- 2021
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16. Analysis of functional outcomes post gastrectomy and oesophagectomy
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Cormack, O. Mc, primary, McLaren, N., additional, Mengardo, V., additional, Andreyev, J., additional, and Allum, W., additional
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- 2019
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17. Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial.
- Author
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Weindelmayer, J., Mengardo, V., Veltri, A., Baiocchi, G. L., Giacopuzzi, S., Verlato, G., de Manzoni, G., and Italian Research Group for Gastric Cancer (GIRCG)
- Subjects
- *
GASTRECTOMY , *LENGTH of stay in hospitals , *STOMACH cancer , *NULL hypothesis - Abstract
Background: Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15 years, and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless, the authors evidenced the moderate/low quality of the included studies and highlighted how 3 out of 4 came from Eastern countries. After 2015, only retrospective studies have been published, all with inconsistent results.Methods: ADiGe (Abdominal Drain in Gastrectomy) Trial is a multicenter prospective randomized non-inferiority trial with a parallel design. It aimed to verify whether avoiding routine use of abdominal drain is burdened with complications, particularly an increase in postoperative invasive procedures. Patients with gastric cancer, scheduled for subtotal or total gastrectomy with curative intent, are eligible for inclusion, irrespective of previous oncological treatment. The primary composite endpoint is reoperation or percutaneous drainage procedures within 30 postoperative days. The primary analysis will verify whether the incidence of the primary composite endpoint is higher in the experimental arm, avoiding routine drain placement, than control arm, undergoing prophylactic drain placement, in order to falsify or support the null hypothesis of inferiority. Secondary endpoints assessed for superiority are overall morbidity and mortality, Comprehensive Complications Index, incidence and time for diagnosis of anastomotic and duodenal leaks, length of hospital stay, and readmission rate. Assuming one-sided alpha of 5%, and cumulative incidence of the primary composite endpoint of 6.4% in the control arm and 4.2% in the experimental one, 364 patients allow to achieve 80% power to detect a non-inferiority margin difference between the arm proportions of 3.6%. Considering a 10% drop-out rate, 404 patients are needed. In order to have a balanced percentage between total and subtotal gastrectomy, recruitment will end at 202 patients for each type of gastrectomy. The surgeon and the patient are blinded until the end of the operation, while postoperative course is not blinded to the patient and caregivers.Discussion: ADiGe Trial could contribute to critically re-evaluate the role of prophylactic drain in gastrectomy, a still widely used procedure.Trial Registration: Prospectively registered (last updated on 29 October 2020) at ClinicalTrials.gov with the identifier NCT04227951 . [ABSTRACT FROM AUTHOR]- Published
- 2021
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18. Reply to letter: obesity and esophagectomy for esophageal cancer: is it only the high BMI that defines prognosis?
- Author
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Mc Cormack, O, primary, Mengardo, V, additional, Pucetti, F, additional, Chaudry, A, additional, and Allum, W H, additional
- Published
- 2018
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19. Management, short and long-term outcomes in septegenerians and octegenerians undergoing gastrectomy for cancer
- Author
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Mengardo, V., primary, McCormack, O., additional, Weindelmayer, J., additional, Chaudry, A., additional, Bencivenga, M., additional, Giacopuzzi, S., additional, Allum, W.H., additional, and de Manzoni, G., additional
- Published
- 2018
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- View/download PDF
20. The impact of obesity on esophagectomy: a meta-analysis
- Author
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Mengardo, V, primary, Pucetti, F, additional, Mc Cormack, O, additional, Chaudry, A, additional, and Allum, W H, additional
- Published
- 2017
- Full Text
- View/download PDF
21. The amount of cells with Signet Ring Cell morphology has a prognostic impact in poorly cohesive gastric carcinoma
- Author
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Bencivenga, M., Treppiedi, E., Verlato, G., Mengardo, V., Giacopuzzi, S., and de Manzoni, G.
- Published
- 2018
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- View/download PDF
22. The impact of obesity on esophagectomy: a meta-analysis.
- Author
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Mengardo, V., Pucetti, F., Mc Cormack, O., Chaudry, A., and Allum, W. H.
- Subjects
- *
ESOPHAGECTOMY , *META-analysis , *BODY mass index , *ESOPHAGEAL cancer , *QUANTITATIVE research - Abstract
The impact of body mass index (BMI) on postoperative outcomes after curative resection for esophageal cancer has been assessed in many studies worldwide with conflicting conclusions. The aim of this metaanalysis is to evaluate the influence of preoperative BMI on surgical and oncologic outcomes after radical surgery for esophageal cancer, in Western studies. A comprehensive electronic search was performed to identify Western publications reporting BMI and outcomes following surgery for esophageal cancer. Articles that did not report preoperative BMI, postoperative morbidity, and early mortality were excluded. Statistical analysis was performed using the OpenMetaAnalyst software (Version 10.10). One hundred and ninety records were examined and 8 studies were included with a total of 2838 patients. The study population was stratified into two groups: a nonobese group (BMI < 30 kg/m2), containing 2199 patients, and an obese group (BMI ≥ 30 kg/m2), with 639 patients. In the obese group, there was an increased risk (up to 35%) of anastomotic leak (P = 0.003; RR: 0.857, 95% CI: 0.497, 0.867). The obese group showed a significantly more favorable five-year overall survival (P = 0.011). Although there was a significant association between anastomotic leak and obesity, patients with obesity also have a better overall 5-year survival. This meta-analysis demonstrates that patients with obesity should be counseled regarding the specific risks of surgery but they can be reassured that despite these risks overall outcome is satisfactory. [ABSTRACT FROM AUTHOR]
- Published
- 2018
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- View/download PDF
23. Management of critically ill surgical patients
- Author
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Mangiante, G., Roberto Padoan, Mengardo, V., Bencivenga, M., and Manzoni, G.
- Subjects
Abdominal compartmental syndrome ,Acute abdomen ,Laparostomy
24. Current practice on the use of prophylactic drain after gastrectomy in Italy: the Abdominal Drain in Gastrectomy ({ADiGe}) survey
- Author
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Mengardo, Valentina, Weindelmayer, Jacopo, Veltri, Alessandro, Giacopuzzi, Simone, Torroni, Lorena, DE MANZONI, Giovanni, Ferdinando, Agresta, Rita, Alfieri, Sergio, Alfieri, Nicola, Antonacci, Gian Luca Baiocchi, Lapo, Bencini, Bencivenga, Maria, Benedetti, Michele, Mattia, Berselli, Alberto, Biondi, Gabriella Teresa Capolupo, Fabio, Carboni, Riccardo, Casadei, Casella, Francesco, Catarci, Marco, Paolo, Cerri, Damiano, Chiari, Eugenio, Cocozza, Giovanni, Colombo, Luca, Cozzaglio, Giorgio, Dalmonte, Maurizio, Degiuli, Maurizio De Luca, Raffaele De Luca, Nicol(`(o)) De Manzini, DE PASQUAL, CARLO ALBERTO, Stefano De Pascale, Nicola De Ruvo, DI COSMO, Mariantonietta, DI LEO, Alberto, Massimiliano Di Paola, Amedeo, Elio, Francesco, Ferrara, Giovanni, Ferrari, Valentino, Fiscon, Uberto, Fumagalli, Gianluca, Garulli, Andrea, Gennai, Irene, Gentile, Paola, Germani, Monica, Gualtierotti, Guerini, Francesca, Angela, Gurrado, Inama, Marco, Filippo La Torre, Ernesto, Laterza, Pasquale, Losurdo, Antonio, Macr(`(i)), Alessandra, Marano, Luigi, Marano, Federico, Marchesi, Fabio, Marino, Marco, Massani, Roberta, Menghi, Marco, Milone, Sarah, Molfino, Mauro, Montuori, Moretto, Gianluigi, Paolo, Morgagni, Emilio, Morpurgo, Moukchar, Abdallah, Luca, Nespoli, Stefano, Olmi, Raffaele, Palaia, Giovanni, Pallabazer, Parise, Paolo, Alessandro, Pasculli, Marco Pericoli Ridolfini, Antonio, Pesce, Enrico, Pinotti, Michele, Pisano, Elia, Poiasina, Vittorio, Postiglione, Stefano, Rausei, Antonio, Rella, Fausto, Rosa, Riccardo, Rosati, Gianmaria, Rossi, Luca, Rossit, Massimo, Rovatti, Laura, Ruspi, DAL SACCO, Luca, Saladino, Edoardo, Andrea, Sansonetti, Sartori, Alberto, Donatella, Scaglione, Stefano, Scaringi, Christian, Schoenthaler, Giuseppe, Sena, Michele, Simone, Leonardo, Solaini, Paolo, Strignano, Nicola, Tartaglia, Silvio, Testa, Mario, Testini, Guido Alberto Massimo Tiberio, Treppiedi, Elio, Alessio, Vagliasindi, Michele, Valmasoni, Jacopo, Vigan(`(o)), Gianpietro, Zanchettin, Andrea, Zanoni, Zardini, Claudio, Antonio Zerbinati and, Mengardo, V, Weindelmayer, J, Veltri, A, Giacopuzzi, S, Torroni, L, de Manzoni, G, Agresta, F, Alfieri, R, Alfieri, S, Antonacci, N, Baiocchi, G, Bencini, L, Bencivenga, M, Benedetti, M, Berselli, M, Biondi, A, Capolupo, G, Carboni, F, Casadei, R, Casella, F, Catarci, M, Cerri, P, Chiari, D, Cocozza, E, Colombo, G, Cozzaglio, L, Dalmonte, G, Degiuli, M, De Luca, M, De Luca, R, De Manzini, N, De Pasqual, C, De Pascale, S, De Ruvo, N, Di Cosmo, M, Di Leo, A, Di Paola, M, Elio, A, Ferrara, F, Ferrari, G, Fiscon, V, Fumagalli, U, Garulli, G, Gennai, A, Gentile, I, Germani, P, Gualtierotti, M, Guerini, F, Gurrado, A, Inama, M, La Torre, F, Laterza, E, Losurdo, P, Macri, A, Marano, A, Marano, L, Marchesi, F, Marino, F, Massani, M, Menghi, R, Milone, M, Molfino, S, Montuori, M, Moretto, G, Morgagni, P, Morpurgo, E, Abdallah, M, Nespoli, L, Olmi, S, Palaia, R, Pallabazer, G, Parise, P, Pasculli, A, Pericoli Ridolfini, M, Pesce, A, Pinotti, E, Pisano, M, Poiasina, E, Postiglione, V, Rausei, S, Rella, A, Rosa, F, Rosati, R, Rossi, G, Rossit, L, Rovatti, M, Ruspi, L, Sacco, L, Saladino, E, Sansonetti, A, Sartori, A, Scaglione, D, Scaringi, S, Schoenthaler, C, Sena, G, Simone, M, Solaini, L, Strignano, P, Tartaglia, N, Testa, S, Testini, M, Tiberio, G, Treppiedi, E, Vagliasindi, A, Valmasoni, M, Vigano, J, Zanchettin, G, Zanoni, A, Zardini, C, Zerbinati, A, Mengardo, Valentina, Weindelmayer, Jacopo, Veltri, Alessandro, Giacopuzzi, Simone, Torroni, Lorena, de Manzoni, Giovanni, and de Manzini, Nicolo
- Subjects
Surgeons ,Postoperative Complications ,Gastrectomy ,Stomach Neoplasms ,Surveys and Questionnaires ,Drain ,Drainage ,Gastric cancer ,Survey ,Humans ,Surgery - Abstract
Evidence against the use of prophylactic drain after gastrectomy are increasing and ERAS guidelines suggest the benefit of drain avoidance. Nevertheless, it is unclear whether this practice is still widespread. We conducted a survey among Italian surgeons through the Italian Gastric Cancer Research Group and the Polispecialistic Society of Young Surgeons, aiming to understand the current use of prophylactic drain. A 28-item questionnaire-based survey was developed to analyze the current practice and the individual opinion about the use of prophylactic drain after gastrectomy. Groups based on age, experience and unit volume were separately analyzed. Response of 104 surgeons from 73 surgical units were collected. A standardized ERAS protocol for gastrectomy was applied by 42% of the respondents. Most of the surgeons, regardless of age, experience, or unit volume, declared to routinely place one or more drain after gastrectomy. Only 2 (1.9%) and 7 surgeons (6.7%) belonging to high volume units, do not routinely place drains after total and subtotal gastrectomy, respectively. More than 60% of the participants remove the drain on postoperative day 4–6 after performing an assessment of the anastomosis integrity. Interestingly, less than half of the surgeons believe that drain is the main tool for leak management, and this percentage further drops among younger surgeons. On the other hand, drain’s role seems to be more defined for duodenal stump leak treatment, with almost 50% of the surgeons recognizing its importance. Routine use of prophylactic drain after gastrectomy is still a widespread practice even if younger surgeons are more persuaded that it could not be advantageous.
- Published
- 2022
25. Preoperative or Perioperative Docetaxel, Oxaliplatin, and Capecitabine (GASTRODOC Regimen) in Patients with Locally-Advanced Resectable Gastric Cancer: A Randomized Phase-II Trial
- Author
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Luigina Graziosi, Uberto Fumagalli Romario, Maria Bencivenga, Franco Roviello, Oriana Nanni, Daniele Marrelli, Giovanni de Manzoni, Silvia Bozzarelli, Francesca Steccanella, Stefano Rausei, Massimo Framarini, Giovanni Sgroi, Annibale Donini, Stefano Santi, Luca Saragoni, Andrea Rinnovati, Giorgio Ercolani, Lorenza Rimassa, Flavia Foca, Paolo Morgagni, Ilaria Proserpio, Valentina Mengardo, Giovanni Luca Frassineti, Carlo Milandri, Manlio Monti, Sarah Molfino, Emilio Parma, Roberto Petrioli, Gian Luca Baiocchi, Gianni Mura, Dino Amadori, Linda Valmorri, Alessandra Signorini, Verena De Angelis, J. Viganò, Silvia Brugnatelli, Monti M., Morgagni P., Nanni O., Framarini M., Saragoni L., Marrelli D., Roviello F., Petrioli R., Romario U.F., Rimassa L., Bozzarelli S., Donini A., Graziosi L., De Angelis V., De Manzoni G., Bencivenga M., Mengardo V., Parma E., Milandri C., Mura G., Signorini A., Baiocchi G., Molfino S., Sgroi G., Steccanella F., Rausei S., Proserpio I., Vigano J., Brugnatelli S., Rinnovati A., Santi S., Ercolani G., Foca F., Valmorri L., Amadori D., and Frassineti G.L.
- Subjects
0301 basic medicine ,Cancer Research ,medicine.medical_specialty ,medicine.medical_treatment ,lcsh:RC254-282 ,Gastroenterology ,Article ,Capecitabine ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Chemotherapy ,Medicine ,Perioperative ,Progression-free survival ,Preoperative ,Gastric cancer ,business.industry ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,medicine.disease ,Oxaliplatin ,Regimen ,030104 developmental biology ,Oncology ,Docetaxel ,030220 oncology & carcinogenesis ,business ,Febrile neutropenia ,medicine.drug - Abstract
Docetaxel associated with oxaliplatin and 5-fluorouracil (FLOT) has been reported as the best perioperative treatment for gastric cancer. However, there is still some debate about the most appropriate number and timing of chemotherapy cycles. In this randomized multicenter phase II study, patients with resectable gastric cancer were staged through laparoscopy and peritoneal lavage cytology, and randomly assigned (1:1) to either four cycles of neoadjuvant chemotherapy (arm A) or two preoperative + two postoperative cycles of docetaxel, oxaliplatin, and capecitabine (DOC) chemotherapy (arm B). The primary endpoint was to assess the percentage of patients receiving all the planned preoperative or perioperative chemotherapeutic cycles. Ninety-one patients were enrolled between September 2010 and August 2016. The treatment was well tolerated in both arms. Thirty-three (71.7%) and 24 (53.3%) patients completed the planned cycles in arms A and B, respectively (p = 0.066), reporting an odds ratio for early interruption of treatment of 0.45 (95% confidence interval (CI): 0.18&ndash, 1.07). Resection was curative in 39 (88.6%) arm A patients and 35 (83.3%) arm B patients. Five-year progression-free survival (PFS) was 51.2% (95% CI: 34.2&ndash, 65.8) in arm A and 40.3% (95% CI: 28.9&ndash, 55.2) in arm B (p = 0.300). Five-year survival was 58.5% (95% CI: 41.3&ndash, 72.2) and 53.9% (95% CI: 35.5&ndash, 69.3) (p = 0.883) in arms A and B, respectively. The planned treatment was more frequently completed and was more active, albeit not significantly, in the neoadjuvant arm than in the perioperative group.
- Published
- 2020
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- View/download PDF
26. Association Between Compliance to an Enhanced Recovery Protocol and Outcome After Elective Surgery for Gastric Cancer. Results from a Western Population-Based Prospective Multicenter Study
- Author
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Andrea Sansonetti, Lapo Bencini, Luca Gianotti, Andrea Coratti, Francesco Casella, Riccardo Rosati, Federica Galli, Jacopo Weindelmayer, Giovanni Colombo, Marta Sandini, Andrea Costanzi, Paolo Parise, Davide Paolo Bernasconi, Stefano De Pascale, Andrea Cossu, Uberto Fumagalli Romario, Giovanni de Manzoni, Stefano Rausei, Dario Maggioni, Valentina Mengardo, Gianotti, L, Fumagalli Romario, U, De Pascale, S, Weindelmayer, J, Mengardo, V, Sandini, M, Cossu, A, Parise, P, Rosati, R, Bencini, L, Coratti, A, Colombo, G, Galli, F, Rausei, S, Casella, F, Sansonetti, A, Maggioni, D, Costanzi, A, Bernasconi, D, De Manzoni, G, Gianotti, Luca, Fumagalli Romario, Uberto, De Pascale, Stefano, Weindelmayer, Jacopo, Mengardo, Valentina, Sandini, Marta, Cossu, Andrea, Parise, Paolo, Rosati, Riccardo, Bencini, Lapo, Coratti, Andrea, Colombo, Giovanni, Galli, Federica, Rausei, Stefano, Casella, Francesco, Sansonetti, Andrea, Maggioni, Dario, Costanzi, Andrea, Bernasconi, Davide P, and De Manzoni, Giovanni
- Subjects
Male ,medicine.medical_specialty ,Comorbidity ,030230 surgery ,Logistic regression ,03 medical and health sciences ,symbols.namesake ,Postoperative Complications ,0302 clinical medicine ,Stomach Neoplasms ,Stomach Neoplasm ,Gastrectomy ,Internal medicine ,Humans ,Medicine ,Age Factor ,Prospective Studies ,Poisson Distribution ,Postoperative Period ,Poisson regression ,ERAS ,Elective surgery ,Prospective cohort study ,Aged ,Elective Surgical Procedure ,business.industry ,gastric cancer ,Age Factors ,Middle Aged ,Length of Stay ,Vascular surgery ,medicine.disease ,Patient Discharge ,Prospective Studie ,Italy ,Elective Surgical Procedures ,030220 oncology & carcinogenesis ,symbols ,Patient Compliance ,Female ,Surgery ,Observational study ,Postoperative Complication ,business ,Human ,Abdominal surgery - Abstract
Background: The association between compliance to an enhanced recovery protocol (ERAS) and outcome after surgery for gastric cancer has been poorly investigated, particularly in Western patients. The aim of the study was to evaluate whether the rate of adherence to the ERAS program was correlated with outcome and time of discharge. Methods: A prospective, observational, multicenter study was designed to be performed at Italian referral centers for gastric surgery. The protocol was discussed and approved by the Italian Research Group on Gastric Cancer. Twenty-three ERAS domains were applied. A multivariate logistic regression was used to assess the association between ERAS compliance and overall and major complication rates. The Poisson regression model (measured as mean ratios) was used to assess the association of ERAS compliance rate and length of stay (LOS). Results: Eight centers participated and 290 subjects with a median age of 73 years were enrolled. The overall rates of adherence to pre-, intra-, and postoperative ERAS items were 69.8%, 60.3%, and 82.5%, respectively. At the multivariate model, there was an association between overall rate of morbidity and an overall ERAS compliance rate greater than 70% (OR 0.413; 95% CI 0.235–0.7240; P 0.002). A similar association was found for major complications (OR 0.328; 95% CI 0.151–0.709; P 0.005). The Poisson regression showed that in patients with ERAS compliance rate >70%, LOS was reduced of approximately 20% (mean ratio 0.812; 95% CI 0.694–0.950; P 0.009). Conclusions: These results suggest a moderate compliance to an ERAS program and a significant association between adherence and outcomes.
- Published
- 2019
27. Prophylactic Drain Placement and Postoperative Invasive Procedures After Gastrectomy: The Abdominal Drain After Gastrectomy (ADIGE) Randomized Clinical Trial.
- Author
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Weindelmayer J, Mengardo V, Ascari F, Baiocchi GL, Casadei R, De Palma GD, De Pascale S, Elmore U, Ferrari GC, Framarini M, Gelmini R, Gualtierotti M, Marchesi F, Milone M, Puca L, Reddavid R, Rosati R, Solaini L, Torroni L, Totaro L, Veltri A, Verlato G, and de Manzoni G
- Subjects
- Humans, Male, Female, Aged, Middle Aged, Prospective Studies, Postoperative Care methods, Length of Stay statistics & numerical data, Gastrectomy adverse effects, Gastrectomy methods, Drainage, Postoperative Complications prevention & control, Stomach Neoplasms surgery, Reoperation statistics & numerical data
- Abstract
Importance: Evidence suggests that prophylactic abdominal drainage after gastrectomy for cancer may reduce postoperative morbidity and hospital stay but this evidence comes from small studies with a high risk of bias. Further research is needed to determine whether drains safely meet their primary purpose of identifying and managing postoperative intraperitoneal collections without the need for reoperation or additional percutaneous drainage., Objective: To determine whether avoiding routine abdominal drainage increased postoperative invasive procedures., Design, Setting, and Participants: The Abdominal Drain in Gastrectomy (ADIGE) Trial was a multicenter prospective randomized noninferiority trial. Enrollment spanned from December 2019 to January 2023. Follow-up evaluations were completed at 30 and 90 days. Eleven centers within the Italian Research Group for Gastric Cancer, encompassing both academic medical centers and community hospitals, were included. Patients with gastric cancer undergoing subtotal or total gastrectomy with curative intent were eligible, excluding those younger than 18 years, with serious comorbidities, or undergoing procedure types outside the scope of the study. Of 803 patients assessed for eligibility, 404 were randomized and 390 were included in final analyses., Interventions: Patients were randomized 1:1 into prophylactic drain or no drain arms., Main Outcomes and Measures: The primary end point was a modified intention-to-treat (mITT) analysis measuring reoperation or percutaneous drainage within 30 postoperative days. The null hypothesis was rejected when the 90% CI upper limit of the proportion difference did not exceed 3.56%. The calculated sample size to achieve 80% power with a 10% dropout rate was 404 patients (202 in each group). Surgeons and patients were blinded until gastrointestinal reconstruction., Results: Of the 404 patients randomized 226 (57.8%) were male; the median (IQR) age was 71 (62-78) years. Intraoperative identification of nonresectable disease occurred in 14 patients, leading to their exclusion from the study, leaving 390 patients. In the mITT analysis, 15 patients (7.7%) in the drain group needed reoperation or percutaneous drainage by postoperative day 30 vs 29 (15%) in the no drain group, favoring the drain group (difference, 7.2%; 90% CI, 2.1-12.4; P = .02). Of note, the difference in the primary composite end point was entirely due to a similar difference in reoperation (5.1% in the drain group vs 12.4% in the no drain group; P = .01). Drain-related complications occurred in 4 patients., Conclusions and Relevance: The findings of this study indicate that refraining from prophylactic drain use after gastrectomy heightened the risk of postoperative invasive procedures, discouraging its avoidance. Future studies identifying high-risk groups could optimize prophylactic drainage decisions., Trial Registration: ClinicalTrials.gov Identifier: NCT04227951.
- Published
- 2025
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- View/download PDF
28. The effect of aging on short- and long-term results after esophagectomy: an international multicenter retrospective analysis.
- Author
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Mengardo V, Weindelmayer J, Ceccherini G, Wilkinson M, de Manzoni G, Allum W, and Giacopuzzi S
- Subjects
- Aged, Middle Aged, Humans, Retrospective Studies, Aging, Disease-Free Survival, Esophagectomy, Esophageal Neoplasms surgery
- Abstract
The optimal treatment for esophageal cancer in elderly patients is still debated and data on postoperative results are limited. This retrospective international study aims to clarify the impact of age on clinical and oncological outcomes after esophagectomy. All patients that underwent esophagectomy for cancer between 2007 and 2016 at two European high-volume Centers have been included in the study. Patients were divided into three groups according to their age: young-age group (YAG) (18-69), middle-age group (70-74) and old-age group (>74). Primary outcome was 5-year overall survival (OS), while secondary outcomes considered were 5-year disease free survival and disease related survival, 90-day morbidity and mortality, readmission rate and radicality. A total of 575 patients were included. No differences emerged in terms of morbidity and length of stay, while mortality increased with aging from 2% in YAG to 4.8% in old-aged (P = 0.003). Old-age patients had less neoadjuvant treatment (P < 0.001), a less aggressive mediastinal lymphadenectomy and presented a more advanced pathological stage. As expected, OS decreased significantly for older patients compared with the other two age groups (P = 0.044) but, on the other hand, disease free and disease related survival were comparable between the groups. Age itself should not be considered a contraindication to esophagectomy. Although in patients older than 75 years postoperative mortality is significantly increased, esophagectomy could be still an option in selected patients, favoring the use of minimally invasive techniques and enhanced recovery protocols., (© The Author(s) 2023. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2024
- Full Text
- View/download PDF
29. The "Weekday Effect" on Enhanced Recovery after Surgery Protocol for Gastrectomy.
- Author
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Weindelmayer J, Mengardo V, Torroni L, Gervasi MC, Hetoja S, De Pasqual CA, Simion D, and Giacopuzzi S
- Subjects
- Humans, Length of Stay, Postoperative Complications etiology, Postoperative Complications surgery, Gastrectomy adverse effects, Gastrectomy methods, Enhanced Recovery After Surgery, Stomach Neoplasms surgery
- Abstract
Introduction: While enhanced recovery after surgery (ERAS) protocol demonstrated to improve outcomes after gastrectomy, some papers evidenced a detrimental effect on postoperative morbidity related to the "weekday effect." We aimed to understand whether the day of gastrectomy could affect postoperative outcomes and compliance with ERAS items., Methods: We included all patients that underwent gastrectomy for cancer between January 2017 and September 2021. Cohort was divided considering the day of surgery: Early group (Monday-Wednesday) and Late group (Thursday-Friday). Compliance with protocol and postoperative outcomes were compared., Results: Two hundred twenty-seven patients were included in Early group, while 154 were in Late group. The groups were comparable in preoperative characteristics. No significant difference in pre/intraoperative and postoperative ERAS items' compliance was apparent between Early and Late groups, with most items exceeding the 70% threshold. Median length of stay was 6.5 days and 6 days in Early and Late groups (p = 0.616), respectively. Morbidity was 50% in both groups, with severe complications that occurred in 13% of Early patients and 15% of Late patients. Ninety-day mortality was 2%, and it was similar between the two groups., Conclusions: In a center with a standardized ERAS protocol, the weekday of gastrectomy has no significant impact on the success of each ERAS item and on postoperative surgical and oncological outcomes., (© 2023 S. Karger AG, Basel.)
- Published
- 2023
- Full Text
- View/download PDF
30. Current practice on the use of prophylactic drain after gastrectomy in Italy: the Abdominal Drain in Gastrectomy (ADiGe) survey.
- Author
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Mengardo V, Weindelmayer J, Veltri A, Giacopuzzi S, Torroni L, and de Manzoni G
- Subjects
- Humans, Gastrectomy methods, Drainage methods, Surveys and Questionnaires, Postoperative Complications prevention & control, Postoperative Complications surgery, Stomach Neoplasms surgery, Surgeons
- Abstract
Evidence against the use of prophylactic drain after gastrectomy are increasing and ERAS guidelines suggest the benefit of drain avoidance. Nevertheless, it is unclear whether this practice is still widespread. We conducted a survey among Italian surgeons through the Italian Gastric Cancer Research Group and the Polispecialistic Society of Young Surgeons, aiming to understand the current use of prophylactic drain. A 28-item questionnaire-based survey was developed to analyze the current practice and the individual opinion about the use of prophylactic drain after gastrectomy. Groups based on age, experience and unit volume were separately analyzed. Response of 104 surgeons from 73 surgical units were collected. A standardized ERAS protocol for gastrectomy was applied by 42% of the respondents. Most of the surgeons, regardless of age, experience, or unit volume, declared to routinely place one or more drain after gastrectomy. Only 2 (1.9%) and 7 surgeons (6.7%) belonging to high volume units, do not routinely place drains after total and subtotal gastrectomy, respectively. More than 60% of the participants remove the drain on postoperative day 4-6 after performing an assessment of the anastomosis integrity. Interestingly, less than half of the surgeons believe that drain is the main tool for leak management, and this percentage further drops among younger surgeons. On the other hand, drain's role seems to be more defined for duodenal stump leak treatment, with almost 50% of the surgeons recognizing its importance. Routine use of prophylactic drain after gastrectomy is still a widespread practice even if younger surgeons are more persuaded that it could not be advantageous., (© 2022. The Author(s).)
- Published
- 2022
- Full Text
- View/download PDF
31. Enhanced Recovery After Surgery can Improve Patient Outcomes and Reduce Hospital Cost of Gastrectomy for Cancer in the West: A Propensity-Score-Based Analysis.
- Author
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Weindelmayer J, Mengardo V, Gasparini A, Sacco M, Torroni L, Carlini M, Verlato G, and de Manzoni G
- Subjects
- Gastrectomy, Hospital Costs, Humans, Length of Stay, Postoperative Complications, Propensity Score, Retrospective Studies, Enhanced Recovery After Surgery, Stomach Neoplasms surgery
- Abstract
Background: Data on ERAS for gastrectomy are scarce, and the majority of the studies come from Eastern countries. Patients in the West are older and suffer from more advanced tumors that impair their clinical condition and often require neoadjuvant treatment. This retrospective study assessed the feasibility and safety of an Enhanced Recovery After Surgery (ERAS) protocol for gastrectomy in a Western center., Methods: We conducted a single-center study of 351 patients operated for gastric cancer: 103, operated from January 2015 to December 2016, followed the standard pathway, while 248, operated from January 2017 to December 2019, followed the ERAS program. The primary outcomes considered were length of hospital stay (LOS) and direct costs. Secondary outcomes were 90-day morbidity and mortality, readmission rate, and compliance with ERAS items. A propensity score (PS) was built on confounding variables., Results: Compliance with ERAS items after the program was ≥ 70%. Univariable analysis evidenced a 2-day median reduction in LOS and a median cost reduction of €826 per patient in the ERAS group. PS-based multivariable analysis confirmed a significant, 2-day decrease in median LOS and a €1097 saving after ERAS introduction. Ninety-day mortality decreased slightly in ERAS group, while complications and readmissions did not change significantly. When complications were included in the multivariable analysis, ERAS retained its significance, although the effects on LOS and cost were blunted to a median reduction of 1 day and €775, respectively., Conclusions: ERAS for gastrectomy improved patients' recovery and reduced hospital costs without changes in morbidity, mortality, or readmission., (© 2021. The Author(s).)
- Published
- 2021
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32. Effectiveness of endoscopic vacuum therapy as rescue treatment in refractory leaks after gastro-esophageal surgery.
- Author
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De Pasqual CA, Mengardo V, Tomba F, Veltri A, Sacco M, Giacopuzzi S, Weindelmayer J, and de Manzoni G
- Subjects
- Anastomotic Leak surgery, Esophagus, Gastrectomy adverse effects, Humans, Stomach surgery, Negative-Pressure Wound Therapy
- Abstract
The treatment of leak after esophageal and gastric surgery is a major challenge. Over the last few years, endoscopic vacuum therapy (E-VAC) has gained popularity in the management of this life-threatening complication. We reported our initial experience on E-VAC therapy as rescue treatment in refractory anastomotic leak and perforation after gastro-esophageal surgery. From September 2017 to December 2019, a total of 8 E-VAC therapies were placed as secondary treatment in 7 patients. Six for anastomotic leak (3 cervical, 1 thoracic, 2 abdominal) and 1 for perforation of the gastric conduit. In 6 cases, E-VAC was placed intracavitary; while in the remaining 2, the sponge was positioned intraluminal (one patient was treated with both approaches). A total of 60 sponges were used in the whole cohort. The median number of sponge insertions was 10 (range: 5-14) with a median treatment duration of 41 days (range: 19-49). A complete healing was achieved in 4 intracavitary (67%) and in 1 intraluminal (50%) E-VAC. We observed only one E-VAC-related complication: a bleeding successfully managed endoscopically. E-VAC therapy seems to be a safe and effective tool in the management of leaks and perforations after upper GI surgery, although with longer healing time when it is used as secondary treatment.
- Published
- 2021
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33. Long-Term Outcomes of Induction Chemotherapy Followed by Chemo-Radiotherapy as Intensive Neoadjuvant Protocol in Patients with Esophageal Cancer.
- Author
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Simoni N, Pavarana M, Micera R, Weindelmayer J, Mengardo V, Rossi G, Cenzi D, Tomezzoli A, Del Bianco P, Giacopuzzi S, De Manzoni G, and Mazzarotto R
- Abstract
Background: A phase II intensive neoadjuvant chemo-radiotherapy (nCRT) protocol for esophageal cancer (EC) was previously tested at our Center with promising results. We here present an observational study to evaluate the efficacy of the protocol also in "real life" patients., Methods: We retrospectively reviewed 122 ECs (45.1% squamous cell (SCC) and 54.9% adenocarcinoma (ADC)) treated with induction docetaxel, cisplatin, and 5-fluorouracil (TCF), followed by concomitant TCF and radiotherapy (50-50.4 Gy/25-28 fractions), between 2008 and 2017. Primary endpoints were overall survival (OS), event-free survival (EFS) and pathological complete response (pCR)., Results: With a median follow-up of 62.1 months (95% CI 50-67.6 months), 5-year OS and EFS rates were 54.8% (95% CI 44.7-63.9) and 42.7% (95% CI 33.1-51.9), respectively. A pCR was observed in 71.1% of SCC and 37.1% of ADC patients ( p = 0.001). At multivariate analysis, ypN+ was a significant prognostic factor for OS (Hazard Ratios (HR) 4.39 [95% CI 2.36-8.18]; p < 0.0001), while pCR was a strong predictor of EFS (HR 0.38 [95% CI 0.22-0.67]; p < 0.0001)., Conclusions: The nCRT protocol achieved considerable long-term survival and pCR rates also in "real life" patients. Further research is necessary to evaluate this protocol in a watch-and-wait approach.
- Published
- 2020
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34. 18 F-FDG PET/CT Metrics Are Correlated to the Pathological Response in Esophageal Cancer Patients Treated With Induction Chemotherapy Followed by Neoadjuvant Chemo-Radiotherapy.
- Author
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Simoni N, Rossi G, Benetti G, Zuffante M, Micera R, Pavarana M, Guariglia S, Zivelonghi E, Mengardo V, Weindelmayer J, Giacopuzzi S, de Manzoni G, Cavedon C, and Mazzarotto R
- Abstract
Background and Objective: The aim of this study was to assess the ability of Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (
18 F-FDG PET/CT) to provide functional information useful in predicting pathological response to an intensive neoadjuvant chemo-radiotherapy (nCRT) protocol for both esophageal squamous cell carcinoma (SCC) and adenocarcinoma (ADC) patients., Material and Methods: Esophageal carcinoma (EC) patients, treated in our Center between 2014 and 2018, were retrospectively reviewed. The nCRT protocol schedule consisted of an induction phase of weekly administered docetaxel, cisplatin, and 5-fluorouracil (TCF) for 3 weeks, followed by a concomitant phase of weekly TCF for 5 weeks with concurrent radiotherapy (50-50.4 Gy in 25-28 fractions). Three18 F-FDG PET/CT scans were performed: before (PET1 ) and after (PET2 ) induction chemotherapy (IC), and prior to surgery (PET3 ). Correlation between PET parameters [maximum and mean standardized uptake value (SUVmax and SUVmean ), metabolic tumor volume (MTV), and total lesion glycolysis (TLG)], radiomic features and tumor regression grade (TGR) was investigated., Results: Fifty-four patients (35 ADC, 19 SCC; 48 cT3/4; 52 cN+) were eligible for the analysis. Pathological response to nCRT was classified as major (TRG1-2, 41/54, 75.9%) or non-response (TRG3-4, 13/54, 24.1%). A major response was statistically correlated with SCC subtype (p = 0.02) and smaller tumor length (p = 0.03). MTV and TLG measured prior to IC (PET1 ) were correlated to TRG1-2 response (p = 0.02 and p = 0.02, respectively). After IC (PET2 ), SUVmean and TLG correlated with major response (p = 0.03 and p = 0.04, respectively). No significance was detected when relative changes of metabolic parameters between PET1 and PET2 were evaluated. At textural quantitative analysis, three independent radiomic features extracted from PET1 images ([JointEnergy and InverseDifferenceNormalized of GLCM and LowGrayLevelZoneEmphasis of GLSZM) were statistically correlated with major response (p < 0.0002)., Conclusions:18 F-FDG PET/CT traditional metrics and textural features seem to predict pathologic response (TRG) in EC patients treated with induction chemotherapy followed by neoadjuvant chemo-radiotherapy. Further investigations are necessary in order to obtain a reliable predictive model to be used in the clinical practice., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The handling editor declared a past co-authorship with one of the authors with several of the authors [NS, RMa]., (Copyright © 2020 Simoni, Rossi, Benetti, Zuffante, Micera, Pavarana, Guariglia, Zivelonghi, Mengardo, Weindelmayer, Giacopuzzi, de Manzoni, Cavedon and Mazzarotto.)- Published
- 2020
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35. Feasibility and safety of an enhanced recovery protocol (ERP) for upper GI surgery in elderly patients (≥ 75 years) in a high-volume surgical center.
- Author
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De Pasqual CA, Torroni L, Gervasi MC, Alberti L, Mengardo V, Benedetti B, Giacopuzzi S, and Weindelmayer J
- Subjects
- Age Factors, Aged, Cardiovascular Diseases epidemiology, Feasibility Studies, Female, Humans, Incidence, Male, Postoperative Complications epidemiology, Safety, Enhanced Recovery After Surgery, Esophagectomy, Gastrectomy, Patient Compliance statistics & numerical data
- Abstract
Enhanced recovery protocols (ERP) have demonstrated their efficacy after esophagectomy and gastrectomy but little is known about their feasibility and safety in elderly patients. Patients submitted to Ivor-Lewis esophagectomy or gastrectomy for cancer between January 2016 and June 2019 were divided into three age groups: young-age group, YG (≤ 65 years, n = 130); middle-age group, MG (66-74 years, n = 101); old-age group, OG (≥ 75 years, n = 74). The groups were compared for adherence to our ERP, morbidity and mortality rates. After esophagectomy, adherence to ERP was comparable between the three groups, overall morbidity was higher in OG, without statistically significant difference, while the incidence of cardiac complications was significantly higher in OG (p = 0.02). After gastrectomy, OG presented a lower adherence to urinary catheter removal and to early mobilization. No difference in overall morbidity rate was observed (p = 0.13). The median length of stay was comparable both after esophagectomy (p = 0.075) and gastrectomy (p = 0.07). Multivariable analysis showed that age ≥ 75 years was not associated with a higher risk of ERP failure either after esophagectomy (p = 0.59) or after gastrectomy (p = 0.83). After esophagectomy, the risk of failure of the ERP program was higher for patients with ASA grade 3-4 (p = 0.03) and for those with postoperative complications (p < 0.001) while after gastrectomy only postoperative complications were associated to higher risk of ERP failure (p < 0.001). In our series, adherence to ERP protocol of patients ≥ 75 years old was similar to that of younger patients after esophagectomy and gastrectomy, without a significant increase in morbi-mortality rates.
- Published
- 2020
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36. Gastric conduit perforation after Ivor Lewis esophagectomy successfully treated with endoscopic vacuum therapy (E-VAC): a case report.
- Author
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Hetoja S, De Pasqual CA, Mengardo V, Weindelmayer J, and Giacopuzzi S
- Abstract
Gastric conduit perforation is a life-threatening complication after esophagectomy and currently there is no consensus about its optimal management. Endoscopic vacuum therapy (E-VAC) is a promising technique for the treatment of leaks and perforations after upper gastro-intestinal surgery. We report the case of a 65 years-old male patient who underwent an Ivor Lewis esophagectomy for esophago-gastric junction adenocarcinoma. He referred to our Emergency Department for septic shock and right hydropneumothorax. We performed an emergency thoracoscopy with intraoperative esophagogastroduodenoscopy which showed a pre-pyloric perforation of the gastric conduit. The perforation was initially treated with unsuccessful primary surgical closure and subsequently by means of E-VAC, firstly placed intraluminal and then intracavitary. With the latter technique, we assisted to a progressive clinical improvement until the definitive healing of the perforation. To our knowledge, this is the first case of a gastric tube perforation after esophagectomy successfully treated with E-VAC., (Published by Oxford University Press and JSCR Publishing Ltd. All rights reserved. © The Author(s) 2020.)
- Published
- 2020
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37. Should we still use prophylactic drain in gastrectomy for cancer? A systematic review and meta-analysis.
- Author
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Weindelmayer J, Mengardo V, Veltri A, Torroni L, Zhao E, Verlato G, and de Manzoni G
- Subjects
- Anastomotic Leak etiology, Drainage adverse effects, Gastrectomy adverse effects, Gastrectomy mortality, Humans, Length of Stay, Randomized Controlled Trials as Topic, Reoperation, Drainage methods, Gastrectomy methods, Stomach Neoplasms surgery
- Abstract
Prophylactic drain in gastrectomy for cancer is still widely used, although some evidence has disputed this practice and spreading enhanced recovery protocol has been pushing towards surgical simplification. This study aimed at assessing the impact of drain placement on important clinical outcomes, evaluating the results of randomised controlled trials (RCTs), or cohort studies whenever information provided by the former was scarce. PubMed, PMC, Cochrane Library, CNKI and Wanfang databases were searched from January 1990 to February 2019, both for RCTs and cohort studies comparing use or avoidance of prophylactic drain in gastric cancer patients undergoing gastrectomy. All RCTs and cohort studies were rated according to Jadad score and Newcastle-Ottawa-Scale, respectively. Meta-analysis was separately performed on RCTs and cohort studies. The following clinical outcomes were considered: anastomotic leak, reoperation rate, additional drain procedure, length of stay, postoperative morbidity, postoperative mortality, readmission rate and drain related complications. Overall, 3 RCTs (330 patients) and 7 cohort studies (2897 patients) were included. Seven studies came from Eastern Countries. Meta-analysis on RCTs evidenced that drain avoidance halves overall morbidity (RR = 0.47, 95%CI 0.26-0.86, p = 0.014) and slightly reduces length of stay (SMD -0.24, 95%CI -0.51-0.03, p = 0.083). Only one postoperative death occurred in the drain group. The other outcomes were either not reported or reported just by one RCT each. Meta-analysis on cohort studies, despite higher statistical power, did not highlight any significant difference. This meta-analysis showed that prophylactic drain avoidance can reduce morbidity and length of stay, while not significantly affecting other major surgical outcomes., Competing Interests: Declaration of competing interest The authors declare that they have no conflict of interest., (Copyright © 2020 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)
- Published
- 2020
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38. A Comprehensive PDX Gastric Cancer Collection Captures Cancer Cell-Intrinsic Transcriptional MSI Traits.
- Author
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Corso S, Isella C, Bellomo SE, Apicella M, Durando S, Migliore C, Ughetto S, D'Errico L, Menegon S, Moya-Rull D, Cargnelutti M, Capelôa T, Conticelli D, Giordano J, Venesio T, Balsamo A, Marchiò C, Degiuli M, Reddavid R, Fumagalli U, De Pascale S, Sgroi G, Rausa E, Baiocchi GL, Molfino S, Pietrantonio F, Morano F, Siena S, Sartore-Bianchi A, Bencivenga M, Mengardo V, Rosati R, Marrelli D, Morgagni P, Rausei S, Pallabazzer G, De Simone M, Ribero D, Marsoni S, Sottile A, Medico E, Cassoni P, Sapino A, Pectasides E, Thorner AR, Nag A, Drinan SD, Wollison BM, Bass AJ, and Giordano S
- Subjects
- Adult, Aged, Aged, 80 and over, Animals, Biomarkers, Tumor genetics, Female, Gene Expression Profiling methods, Genes, ras genetics, Humans, Male, Mice, Mice, Inbred NOD, Mice, SCID, Microsatellite Instability, Middle Aged, Neoplasm Staging methods, Phenotype, Prognosis, Stomach Neoplasms pathology, Stomach Neoplasms genetics, Transcription, Genetic genetics
- Abstract
Gastric cancer is the world's third leading cause of cancer mortality. In spite of significant therapeutic improvements, the clinical outcome for patients with advanced gastric cancer is poor; thus, the identification and validation of novel targets is extremely important from a clinical point of view. We generated a wide, multilevel platform of gastric cancer models, comprising 100 patient-derived xenografts (PDX), primary cell lines, and organoids. Samples were classified according to their histology, microsatellite stability, Epstein-Barr virus status, and molecular profile. This PDX platform is the widest in an academic institution, and it includes all the gastric cancer histologic and molecular types identified by The Cancer Genome Atlas. PDX histopathologic features were consistent with those of patients' primary tumors and were maintained throughout passages in mice. Factors modulating grafting rate were histology, TNM stage, copy number gain of tyrosine kinases/ KRAS genes, and microsatellite stability status. PDX and PDX-derived cells/organoids demonstrated potential usefulness to study targeted therapy response. Finally, PDX transcriptomic analysis identified a cancer cell-intrinsic microsatellite instability (MSI) signature, which was efficiently exported to gastric cancer, allowing the identification, among microsatellite stable (MSS) patients, of a subset of MSI-like tumors with common molecular aspects and significant better prognosis. In conclusion, we generated a wide gastric cancer PDX platform, whose exploitation will help identify and validate novel "druggable" targets and optimize therapeutic strategies. Moreover, transcriptomic analysis of gastric cancer PDXs allowed the identification of a cancer cell-intrinsic MSI signature, recognizing a subset of MSS patients with MSI transcriptional traits, endowed with better prognosis. SIGNIFICANCE: This study reports a multilevel platform of gastric cancer PDXs and identifies a MSI gastric signature that could contribute to the advancement of precision medicine in gastric cancer., (©2019 American Association for Cancer Research.)
- Published
- 2019
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39. Is There Any Role for Super-Extended Limphadenectomy in Advanced Gastric Cancer? Results of an Observational Study from a Western High Volume Center.
- Author
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Bencivenga M, Verlato G, Mengardo V, Scorsone L, Sacco M, Torroni L, Giacopuzzi S, and de Manzoni G
- Abstract
Background: Although the Japan Clinical Oncology Group (JCOG) 9501 trial did not find that prophylactic D3 lymphadenectomy led to any survival advantage over D2 lymphadenectomy, it did find that the prognosis of subserosal and N0 gastric cancer patients improved. The aim of this retrospective observational study was to compare survival after D2 or D3 lymphadenectomy in different patient subgroups., Methods: The study considered all of the patients who underwent D2 or D3 lymphadenectomy at a high-volume center in Verona (Italy) between 1992 and 2011. After excluding patients with Bormann IV or neuroendocrine tumors, early gastric cancers, or non-curative resections, the analysis involved 301 R0 patients: 100 who underwent D2, and 201 who underwent D3 lymphadenectomy. Post-operative deaths and deaths due to recurrences were considered as terminal events in the survival analysis., Results: The D2 patients were significantly older than the D3 patients at baseline (69.8 ± 2.3 vs. 62.2 ± 10.7 years). The median number of retrieved nodes was 29 (interquartile range: 24.5-39) after D2, and 43 (34-52) after D3. The five-year disease-related survival rate was similar after D2 (44%, 95% confidence interval (CI) 34-54%) and D3 (41%, 34-48%) ( p = 0.766). A Cox model controlling for sex, age, tumor site, Laurén histology, and T and N stages showed that the risk of cancer-related death after D3 was similar to that recorded after D2 (hazard ratio 0.97, 95% CI 0.67-1.42). There was a significant interaction between the T status and the extension of the lymphadenectomy ( p = 0.012), with the prognosis being better after D2 in T2 and T4b patients, and after D3 in T3 patients., Conclusions: The findings of this study suggest that D3 lymphadenectomy is not routinely indicated for patients with advanced gastric cancer, although differences in survival after D3 across T tiers deserve further consideration.
- Published
- 2019
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40. Association Between Compliance to an Enhanced Recovery Protocol and Outcome After Elective Surgery for Gastric Cancer. Results from a Western Population-Based Prospective Multicenter Study.
- Author
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Gianotti L, Fumagalli Romario U, De Pascale S, Weindelmayer J, Mengardo V, Sandini M, Cossu A, Parise P, Rosati R, Bencini L, Coratti A, Colombo G, Galli F, Rausei S, Casella F, Sansonetti A, Maggioni D, Costanzi A, Bernasconi DP, and De Manzoni G
- Subjects
- Age Factors, Aged, Comorbidity, Elective Surgical Procedures, Female, Humans, Italy, Male, Middle Aged, Patient Discharge, Poisson Distribution, Postoperative Complications prevention & control, Postoperative Period, Prospective Studies, Gastrectomy, Length of Stay, Patient Compliance, Postoperative Complications epidemiology, Stomach Neoplasms surgery
- Abstract
Background: The association between compliance to an enhanced recovery protocol (ERAS) and outcome after surgery for gastric cancer has been poorly investigated, particularly in Western patients. The aim of the study was to evaluate whether the rate of adherence to the ERAS program was correlated with outcome and time of discharge., Methods: A prospective, observational, multicenter study was designed to be performed at Italian referral centers for gastric surgery. The protocol was discussed and approved by the Italian Research Group on Gastric Cancer. Twenty-three ERAS domains were applied. A multivariate logistic regression was used to assess the association between ERAS compliance and overall and major complication rates. The Poisson regression model (measured as mean ratios) was used to assess the association of ERAS compliance rate and length of stay (LOS)., Results: Eight centers participated and 290 subjects with a median age of 73 years were enrolled. The overall rates of adherence to pre-, intra-, and postoperative ERAS items were 69.8%, 60.3%, and 82.5%, respectively. At the multivariate model, there was an association between overall rate of morbidity and an overall ERAS compliance rate greater than 70% (OR 0.413; 95% CI 0.235-0.7240; P 0.002). A similar association was found for major complications (OR 0.328; 95% CI 0.151-0.709; P 0.005). The Poisson regression showed that in patients with ERAS compliance rate >70%, LOS was reduced of approximately 20% (mean ratio 0.812; 95% CI 0.694-0.950; P 0.009)., Conclusions: These results suggest a moderate compliance to an ERAS program and a significant association between adherence and outcomes.
- Published
- 2019
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41. Multicenter Study of Presentation, Management, and Postoperative and Long-Term Outcomes of Septegenerians and Octogenerians Undergoing Gastrectomy for Gastric Cancer.
- Author
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Mengardo V, Cormack OM, Weindelmayer J, Chaudry A, Bencivenga M, Giacopuzzi S, Allum WH, and de Manzoni G
- Subjects
- Adenocarcinoma pathology, Adenocarcinoma surgery, Adult, Aged, Aged, 80 and over, Comorbidity, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prognosis, Retrospective Studies, Risk Factors, Stomach Neoplasms pathology, Stomach Neoplasms surgery, Survival Rate, Time Factors, Adenocarcinoma mortality, Gastrectomy mortality, Postoperative Complications mortality, Stomach Neoplasms mortality
- Abstract
Background: The optimal treatment strategy for elderly patients with gastric cancer is still controversial. This study aimed to assess the impact of age on short- and long-term outcomes after treatment for primary gastric cancer., Methods: From January 2004 to December 2014, a total of 507 patients underwent gastrectomy for gastric adenocarcinoma at two high-volume upper gastrointestinal (GI) centers. The patients were classified into three groups as follows: group A (patients ≤ 69 years old, n = 266), group B (patients 70-79 years old, n = 166), and group C (patients ≥ 80 years old, n = 75). Clinicopathologic characteristics as well as, short- and long-term outcomes were compared between the groups., Results: The patients in groups B and C had more comorbidities, whereas the younger subjects (group A) had more advanced tumor stages. Less extensive surgery was performed in the groups B and C. Older patients (age ≥ 70 years) had more postoperative medical complications. Moreover, group C had a higher postoperative mortality rate (8.1%) than group A (1.8%) or group B (1.9%). In the multivariable analysis, age older than 80 years (group C) was a negative independent factor for overall survival (OS) (hazard ratio [HR], 2.36) compared with group A, whereas group B seemed to have a comparable risk (HR, 1.37). Notably, the three groups did not show significant differences in disease-related survival (DRS)., Conclusion: The data suggest that patients 70-79 years of age show a risk of postoperative death comparable with that of younger subjects. However, patients older than 80 years should be carefully selected for surgical treatment due to the increased risk of postoperative mortality.
- Published
- 2018
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42. Clinical pathways in gastric cancer care.
- Author
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Bencivenga M, Palla I, Scorsone L, Bortolami A, Mengardo V, Pavarana M, Turchetti G, and de Manzoni G
- Subjects
- Adenocarcinoma pathology, Follow-Up Studies, Humans, Italy, Neoplasm Staging, Patient Care Team, Postoperative Care, Stomach Neoplasms pathology, Adenocarcinoma diagnosis, Adenocarcinoma surgery, Critical Pathways, Stomach Neoplasms diagnosis, Stomach Neoplasms surgery
- Abstract
The diagnostic-therapeutic pathways (DTPs) are emerging as useful instruments for clinical management of complex diseases as gastric cancer, whose treatment is challenging and requires a multidisciplinary approach. However, the DPTs of patients with gastric cancer are still not defined yet. The aim of this study was to define the optimal DPT to be applied for patients with gastric cancer in the Veneto region. Rather than defining the ideal DTPs a priori, we conducted a preliminary research by analyzing the differences in the actual DPTs for patients with gastric cancer among different hospitals (hub and spokes) in Veneto. Then, the final DPT was elaborated based on the current available best clinical evidences; however, also the areas of homogeneity among the actual DPTs of the included centers as well as the critical issues that had emerged by our preliminary analysis were taken into account for pathway design. High heterogeneity in actual DTPs of patients with gastric cancer was observed among the analyzed centres. Moreover, some of the major criticisms have been found at crucial points of the current pathways. Based on these data, a reference path that is applicable to the whole-regional health network was constructed. The reference DTP is focused on multidisciplinary team management of patients with gastric cancer. Clinical pathways are essential tools to properly manage complex diseases such as gastric cancer. As such, more efforts should be done to implement their use.
- Published
- 2018
- Full Text
- View/download PDF
43. Do all the European surgeons perform the same D2? The need of D2 audit in Europe.
- Author
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Bencivenga M, Verlato G, Mengardo V, Weindelmayer J, and Allum WH
- Subjects
- Europe, Humans, Lymph Node Excision methods, Lymph Node Excision standards, Lymphatic Metastasis, Practice Guidelines as Topic, Stomach, Stomach Neoplasms pathology, Guideline Adherence statistics & numerical data, Lymph Node Excision statistics & numerical data, Stomach Neoplasms surgery, Surgeons standards
- Abstract
Although D2 lymphadenectomy is the standard of care for radical intent surgical treatment of gastric cancer, the real compliance with D2 dissection in Europe is still unknown. The aim of the present study is to analyze the variation in lymph-node harvesting reported after D2 dissection in European series and to present a European project aiming at evaluating the real compliance with D2 lymphadenectomy. A PubMed search for papers using the key words "D2 lymphadenectomy" and "gastric cancer" from 2008 to 2017 was undertaken. Only studies by European authors in English language reporting the number of retrieved lymph nodes after D2 lymphadenectomy were included. The results of literature review were descriptively reported. The literature survey yielded 16 studies: 2 RCTs, 3 observational multicentre studies, and 11 observational monocentric studies. A large variability was found in the number of retrieved nodes, which, overall, was the lowest in the surgical series from Eastern Europe (16.6 and 19.9 in the Lithuanian and Hungarian series, respectively) and the highest in an Italian RCT. The within-study variability was also quite high, especially in multicentre RCTs and observational studies. Sample size tended to have a larger effect on the variability of lymph nodes retrieved than on its actual value. However, in both cases, the relation was not significant, due to the low number of studies considered. There is a large variability in the number of retrieved nodes after D2 dissection in European series. This reflects, at least partly, different approaches to D2 lymphadenectomy by European surgeons and may be responsible of the different outcomes observed in patients with gastric cancer across Europe. Therefore, there is the need to standardize the practice of D2 gastrectomy in Europe and to define possible variations of D2 procedures according to tumour's characteristics.
- Published
- 2018
- Full Text
- View/download PDF
44. Para-aortic lymphadenectomy in surgery for gastric cancer: current indications and future perspectives.
- Author
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Mengardo V, Bencivenga M, Weindelmayer J, Pavarana M, Giacopuzzi S, and de Manzoni G
- Subjects
- Aorta, Combined Modality Therapy, Humans, Lymphatic Metastasis, Stomach Neoplasms pathology, Stomach Neoplasms therapy, Lymph Node Excision methods, Stomach Neoplasms surgery
- Abstract
Involvement of para-aortic nodes (PAN) has been detected at pathological examination in 10-25% of locally advanced gastric cancer. Based on these data of nodal diffusion, the lymphadenectomy of para-aortic stations would be desirable in locally advanced gastric cancer. However, the debate on the oncological benefit of para-aortic nodes dissection is still not solved. A review of the literature was performed and papers reporting either the rate of para-aortic nodal metastases or the long-term survival outcomes after D2+ para-aortic nodes dissection (PAND) or D3 lymphadenectomy were descriptively reported. The literature survey yielded 14 studies. Most of the papers show the outcome of series of advanced gastric cancer treated with surgery alone, while starting from 2012, 3 articles report the outcomes of D2 + PAND or D3 lymphadenectomy after preoperative chemotherapy. The rate of PAN metastases ranges between 8.5 and 28% in surgical series. Survival outcomes largely improved in series of patients treated with multimodal approach compared to those of surgery alone. In patients with clinically detected para-aortic nodal metastases, preoperative chemotherapy followed by PAND is indicated. More data are needed to clarify the indication to prophylactic PAND in the era of multimodal treatment, anyway super-extended lymphadenectomies have to be performed by experienced surgeons in dedicated centres.
- Published
- 2018
- Full Text
- View/download PDF
45. Management of critically ill surgical patients Case reports.
- Author
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Mangiante G, Padoan R, Mengardo V, Bencivenga M, and de Manzoni G
- Subjects
- Abdomen, Acute etiology, Adenocarcinoma complications, Adenocarcinoma surgery, Aged, Aged, 80 and over, Cecal Neoplasms complications, Cecal Neoplasms surgery, Colectomy, Critical Illness, Crohn Disease surgery, Disease Management, Drainage, Female, Humans, Ileostomy, Intestinal Perforation surgery, Intra-Abdominal Hypertension complications, Jejunostomy, Male, Middle Aged, Ovarian Neoplasms surgery, Ovariectomy, Pancreatitis surgery, Suture Techniques, Intra-Abdominal Hypertension surgery, Laparotomy methods, Negative-Pressure Wound Therapy methods, Postoperative Complications surgery
- Abstract
The acute abdomen (AA) still remains a challenging situation for surgeons. New pathological conditions have been imposed to our attention in this field in recent years. The definition of abdominal compartmental syndrome (ACS) in surgical practice and the introduction of new biological matrices, with the concepts of tension-free (TS) repair of incisional hernias, prompted us to set up new therapeutic strategies for the treatment of patients with AA. Thus we reviewed the cases of AA that we observed in recent years in which we performed a laparostomy in order to prevent or to treat an ACS. They are all cases of acute abdomen (AA), but from different origin, including chronic diseases, as in the course of inflammatory bowel disease (IBD), and acute pancreatitis. In all the cases, the open abdominal cavity was covered with a polyethylene sheet. The edges of the wound were sutured to the plastic sheet, and a traction exerted by a device that causes a negative pressure was added. This method was adopted in several cases without randomization, and resulted in excellent patient's outcomes., Key Words: Abdominal compartmental syndrome, Acute abdomen, Laparostomy.
- Published
- 2016
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