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4 results on '"Müller, Verena"'

1. Comprehensive complication index for NOTES procedures: results from a randomized controlled trial and comparison to published NOTES complication data.

Author

Borchert DH, Federlein M, Müller VA, Wagenpfeil S, and Eisele RM

Subjects
Cholecystectomy, Laparoscopic, Female, Humans, Randomized Controlled Trials as Topic, Cholecystectomy methods, Natural Orifice Endoscopic Surgery adverse effects, Vagina surgery
Abstract

Objective: This investigation uses the comprehensive complication index (CCI) to compare complications after natural orifice transluminal endoscopic surgery (NOTES) procedures., Background: NOTES procedures are developed to miniaturize surgical trauma. NOTES publications inconsistently report complications. The CCI improves reporting of complications., Methods: The CCI is calculated using complication data from a single center, double blind, randomized controlled trial comparing transvaginal [transvaginal cholecystectomy (TVC), N = 41] and conventional laparoscopic cholecystectomy (CLC, N = 51). Complications are assessed using the classification of surgical complications (CSC). Two different scenarios are applied to the CSC for definition of complications with an emphasis on minor complications. CSC data are fed into the free online CCI-calculator. The CCIs from complication data from other NOTES reports are calculated accordingly and compared to our results., Results: The CCI allows easy indexing of complications with or without a CSC table. For scenario I, the mean CCI of CLC versus TVC is 3.3 (± 6.3; SD) versus 3.5 (± 6.4; n.s.) and for scenario II it is 7.6 (± 6.4) versus 6.5 (± 7.0; n.s.). The difference of the mean between the two scenarios is highly significant (p < 0.000). The mean CCIs of both groups and scenarios are below the CCI of 8.7 for a grade I CSC complication. Similar calculation of CCIs from other NOTES publications yields mean CCIs below 8.7 for the surgical procedures reported., Conclusion: The CCI results in a single, easily comparable complication index for surgical procedures whereas the CSC yields tabular results. A significant difference in interpretation occurs with variation in definition of complications. Average CCIs below a value of 10 describe low complication rates. Authors need to describe their definition of complications if using the CSC and the CCI. More emphasis should be given to reporting of minor complications. The use of the CCI for NOTES procedures will enable international comparison.

Published
2015
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4. International multicenter trial on clinical natural orifice surgery--NOTES IMTN study: preliminary results of 362 patients

Author

Paulo Ayrosa Galvão Ribeiro, Manoel Galvao Neto, Muthukumaran Ranagrajan, N.A Gómez, T.S. Balashanmugan, Priyadarshan Anand Jategaonkar, K. Sivakumar, Fausto D'Ávila Avila, Camilo Boza, Ramakrishnan Parthasarathi, Ricardo Zorron, Francesco Corcione, Chinnusamy Palanivelu, Raffaele Pugliese, Luiz Henrique de Sousa, Marcos Filgueiras, P. S. Rajan, Diego Cuccurullo, Antonello Forgione, Gustavo Salinas, Lil Saavedra, Verena Müller, Almino Ramos, Jens Burghardt, Edwin Ramírez, Anibal Wood Branco, José Américo Gomides de Sousa, Susana Martins, Klaus Gellert, Luis DeCarli, Josemberg Marins Campos, Jose Inacio Sanseverino, William Kondo, Palanisamy Senthilnathan, Mohan Prasad, Alcides Branco, Zorron, Ricardo, Palanivelu, Chinnusamy, Galvão Neto, Manoel Passo, Ramos, Almino, Salinas, Gustavo, Burghardt, Jen, Decarli, Lui, Henrique Sousa, Luiz, Forgione, Antonello, Pugliese, Raffaele, Branco, Alcides J, Balashanmugan, T. S., Boza, Camilo, Corcione, Francesco, D'Ávila Avila, Fausto, Arturo Gómez, Néstor, Galvão Ribeiro, Paulo Ayrosa, Martins, Susana, Filgueiras, Marco, Gellert, Klau, Wood Branco, Anibal, Kondo, William, Inacio Sanseverino, Jose, De Sousa, José Américo G., Saavedra, Lil, Ramírez, Edwin, Campos, Josemberg, Sivakumar, K., Seshiyer Rajan, Pidigu, Anand Jategaonkar, Priyadarshan, Ranagrajan, Muthukumaran, Parthasarathi, Ramakrishnan, Senthilnathan, Palanisamy, Prasad, Mohan, Cuccurullo, Diego, and Müller, Verena

Subjects
Registrie, medicine.medical_specialty, Time Factors, Time Factor, medicine.medical_treatment, Natural orifice surgery, Minimally invasive surgery, Multicenter trial, medicine, Appendectomy, Humans, Minimally Invasive Surgical Procedures, Cholecystectomy, Prospective Studies, Registries, Prospective study, Laparoscopy, Prospective cohort study, medicine.diagnostic_test, business.industry, General surgery, NOTES, Stomach, Minimally Invasive Surgical Procedure, Institutional review board, Multicenter study, Natural orifice translumenal endoscopic surgery, Surgery, Prospective Studie, Vagina, Operative time, Female, business, Abdominal surgery, Human
Abstract

Objectives: Natural orifice translumenal endoscopic surgery (NOTES) is evolving as a promising alternative for abdominal surgery. IMTN Registry was designed to prospectively document early results of natural orifice surgery among a large group of clinical cases. Methods: Sixteen centers from 9 countries were approved to participate in the study, based on study protocol requirements and local institutional review board approval. Transgastric and transvaginal endoscopic natural orifice surgery was clinically applied in 362 patients. Intraoperative and postoperative parameters were prospectively documented. Results: Mean operative time for transvaginal cholecystectomy was 96 minutes, compared with 111 minute for transgastric cholecystectomy. A general complication rate of 8.84% was recorded (grade I-II representing 5.8%, grade III-IV representing 3.04%). No requirement for any analgesia was found in one fourth of cholecystectomy and appendectomy patients. Conclusions: Results of clinical applications of NOTES in the IMTN Study showed the feasibility of different methods of this new minimally invasive alternative for laparoscopic and open surgery.

Published
2010

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