38 results on '"R. Bergamaschi"'
Search Results
2. Transanal Hemorrhoidal Dearterialization With Mucopexy Versus Ferguson Hemorrhoidectomy for Prolapsed Internal Hemorrhoids: A Multicenter Prospective Study.
- Author
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Gachabayov M, Angelos G, Orangio G, Abcarian H, and Bergamaschi R
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- Humans, Prospective Studies, Quality of Life, Treatment Outcome, Ligation, Pain, Hemorrhoids surgery, Hemorrhoids complications, Hemorrhoidectomy
- Abstract
Objective: To compare transanal hemorrhoidal dearterialization (THD) with mucopexy to Ferguson hemorrhoidectomy in terms of recurrence rates and quality of life., Background: There is uncertainty regarding the durability of the therapeutic effect of THD with mucopexy compared with Ferguson hemorrhoidectomy in terms of recurrence rates., Methods: This was a multicenter prospective study. Participating surgeons performed the operation they knew best enrolling 10 patients each. Surgeons' unedited videos were reviewed by an independent expert. Patients with prolapsed internal hemorrhoids in at least 3 columns were eligible. The primary endpoint was recurrence rates defined as prolapsing internal hemorrhoids. Patient-reported outcomes and satisfaction were evaluated with Pain Scale and Brief Pain Inventory, Fecal Incontinence Quality Of Life (FIQOL), Cleveland Clinic Incontinence, Constipation, Short-Form 12 scores, and Patient satisfaction (4-point Likert) scale., Results: Twenty surgeons enrolled 197 patients. THD patients had lower Visual pain scores at postoperative day (POD) 1 (6.2 vs 8.3, P =0.047), POD7 (4.5 vs 7.7, P =0.021), POD14 (2.8 vs 5.3, P <0.001), and medication use at POD14 (23% vs 58%, P <0.001). Median follow-up was 3.1 (1.0-5.5) years. Recurrence rates did not differ between the study arms (5.9% vs 2.4%, P =0.253). Patient satisfaction rate was higher after THD at POD14 (76.4% vs 52.5%, P =0.031) and 3 months (95.1% vs 63.3%, P =0.029), but did not differ at 6 months (91.7% vs 88%, P =0.228) and 1 year (94.2% vs 88%, P =0.836)., Conclusion: THD with mucopexy was associated with improved patient-reported outcomes and quality of life as compared with Ferguson hemorrhoidectomy with nonsignificantly different recurrence rates., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2023
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3. Association of Latitude and Exposure to Ultraviolet B Radiation With Severity of Multiple Sclerosis: An International Registry Study.
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Vitkova M, Diouf I, Malpas C, Horakova D, Kubala Havrdova E, Patti F, Ozakbas S, Izquierdo G, Eichau S, Shaygannejad V, Onofrj M, Lugaresi A, Alroughani R, Prat A, Larochelle C, Girard M, Duquette P, Terzi M, Boz C, Grand'Maison F, Sola P, Ferraro D, Grammond P, Butzkueven H, Buzzard K, Skibina O, Yamout BI, Karabudak R, Gerlach O, Lechner-Scott J, Maimone D, Bergamaschi R, Van Pesch V, Iuliano G, Cartechini E, José Sà M, Ampapa R, Barnett M, Hughes SE, Ramo-Tello CM, Hodgkinson S, Spitaleri DLA, Petersen T, Butler EG, Slee M, McGuigan C, McCombe PA, Granella F, Cristiano E, Prevost J, Taylor BV, Sãnchez-Menoyo JL, Laureys G, Van Hijfte L, Vucic S, Macdonell RA, Gray O, Olascoaga J, Deri N, Fragoso YD, Shaw C, and Kalincik T
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- Disability Evaluation, Female, Humans, Male, Registries, Severity of Illness Index, Ultraviolet Rays adverse effects, Multiple Sclerosis diagnosis, Multiple Sclerosis epidemiology
- Abstract
Background and Objectives: The severity of multiple sclerosis (MS) varies widely among individuals. Understanding the determinants of this heterogeneity will help clinicians optimize the management of MS. The aim of this study was to investigate the association between latitude of residence, UV B radiation (UVB) exposure, and the severity of MS., Methods: This observational study used the MSBase registry data. The included patients met the 2005 or 2010 McDonald diagnostic criteria for MS and had a minimum dataset recorded in the registry (date of birth, sex, clinic location, date of MS symptom onset, disease phenotype at baseline and censoring, and ≥1 Expanded Disability Status Scale score recorded). The latitude of each study center and cumulative annualized UVB dose at study center (calculated from National Aeronautics and Space Administration's Total Ozone Mapping Spectrometer) at ages 6 and 18 years and the year of disability assessment were calculated. Disease severity was quantified with Multiple Sclerosis Severity Score (MSSS). Quadratic regression was used to model the associations between latitude, UVB, and MSSS., Results: The 46,128 patients who contributed 453,208 visits and a cumulative follow-up of 351,196 patient-years (70% women, mean age 39.2 ± 12 years, resident between latitudes 19°35' and 56°16') were included in this study. Latitude showed a nonlinear association with MS severity. In latitudes <40°, more severe disease was associated with higher latitudes (β = 0.08, 95% CI 0.04-0.12). For example, this translates into a mean difference of 1.3 points of MSSS between patients living in Madrid and Copenhagen. No such association was observed in latitudes <40° (β = -0.02, 95% CI -0.06 to 0.03). The overall disability accrual was faster in those with a lower level of estimated UVB exposure before the age of 6 years (β = - 0.5, 95% CI -0.6 to 0.4) and 18 years (β = - 0.6, 95% CI -0.7 to 0.4), as well as with lower lifetime UVB exposure at the time of disability assessment (β = -1.0, 95% CI -1.1 to 0.9)., Discussion: In temperate zones, MS severity is associated with latitude. This association is mainly, but not exclusively, driven by UVB exposure contributing to both MS susceptibility and severity., (© 2022 American Academy of Neurology.)
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- 2022
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4. Comment on "Local Recurrence After taTME for Rectal Cancer".
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Bergamaschi R, Gachabayov M, Orangio G, and Remzi F
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- Humans, Proctectomy, Rectal Neoplasms surgery
- Abstract
Competing Interests: The authors report no conflicts of interest.
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- 2021
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5. Comment on: "Neyman's Bias in Online Voluntary Databases!"
- Author
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Felsenreich DM, Gachabayov M, Rojas A, Bendl R, Palmer S, and Bergamaschi R
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- Bias, Databases, Factual, Humans, Models, Statistical
- Abstract
Competing Interests: The authors have no conflicts of interest or financial ties to disclose.
- Published
- 2021
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6. Natalizumab, Fingolimod and Dimethyl Fumarate Use and Pregnancy-Related Relapse and Disability in Women With Multiple Sclerosis.
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Yeh WZ, Widyastuti PA, Van der Walt A, Stankovich J, Havrdova E, Horakova D, Vodehnalova K, Ozakbas S, Eichau S, Duquette P, Kalincik T, Patti F, Boz C, Terzi M, Yamout BI, Lechner-Scott J, Sola P, Skibina OG, Barnett M, Onofrj M, Sá MJ, McCombe PA, Grammond P, Ampapa R, Grand'Maison F, Bergamaschi R, Spitaleri DLA, Van Pesch V, Cartechini E, Hodgkinson S, Soysal A, Saiz A, Gresle M, Uher T, Maimone D, Turkoglu R, Hupperts RM, Amato MP, Granella F, Oreja-Guevara C, Altintas A, Macdonell RA, Castillo-Trivino T, Butzkueven H, Alroughani R, and Jokubaitis VG
- Abstract
Objective: To investigate pregnancy-related disease activity in a contemporary multiple sclerosis (MS) cohort., Methods: Using data from the MSBase Registry, we included pregnancies conceived after 31 Dec 2010 from women with relapsing-remitting MS or clinically isolated syndrome. Predictors of intrapartum relapse, and postpartum relapse and disability progression were determined by clustered logistic regression or Cox regression analyses., Results: We included 1998 pregnancies from 1619 women with MS. Preconception annualized relapse rate (ARR) was 0.29 (95% CI 0.27-0.32), fell to 0.19 (0.14-0.24) in third trimester, and increased to 0.59 (0.51-0.67) in early postpartum. Among women who used fingolimod or natalizumab, ARR before pregnancy was 0.37 (0.28-0.49) and 0.29 (0.22-0.37), respectively, and increased during pregnancy. Intrapartum ARR decreased with preconception dimethyl fumarate use. ARR spiked after delivery across all DMT groups. Natalizumab continuation into pregnancy reduced the odds of relapse during pregnancy (OR 0.76 per month [0.60-0.95], p=0.017). DMT re-initiation with natalizumab protected against postpartum relapse (HR 0.11 [0.04-0.32], p<0.0001). Breastfeeding women were less likely to relapse (HR 0.61 [0.41-0.91], p=0.016). 5.6% of pregnancies were followed by confirmed disability progression, predicted by higher relapse activity in pregnancy and postpartum., Conclusion: Intrapartum and postpartum relapse probabilities increased among women with MS after natalizumab or fingolimod cessation. In women considered to be at high relapse risk, use of natalizumab before pregnancy and continued up to 34 weeks gestation, with early re-initiation after delivery is an effective option to minimize relapse risks. Strategies of DMT use have to be balanced against potential fetal/neonatal complications., (© 2021 American Academy of Neurology.)
- Published
- 2021
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7. Effect of Disease-Modifying Therapy on Disability in Relapsing-Remitting Multiple Sclerosis Over 15 Years.
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Kalincik T, Diouf I, Sharmin S, Malpas C, Spelman T, Horakova D, Havrdova EK, Trojano M, Izquierdo G, Lugaresi A, Prat A, Girard M, Duquette P, Grammond P, Jokubaitis V, van der Walt A, Grand'Maison F, Sola P, Ferraro D, Shaygannejad V, Alroughani R, Hupperts R, Terzi M, Boz C, Lechner-Scott J, Pucci E, Van Pesch V, Granella F, Bergamaschi R, Spitaleri D, Slee M, Vucic S, Ampapa R, McCombe P, Ramo-Tello C, Prevost J, Olascoaga J, Cristiano E, Barnett M, Saladino ML, Sanchez-Menoyo JL, Hodgkinson S, Rozsa C, Hughes S, Moore F, Shaw C, Butler E, Skibina O, Gray O, Kermode A, Csepany T, Singhal B, Shuey N, Piroska I, Taylor B, Simo M, Sirbu CA, Sas A, and Butzkueven H
- Subjects
- Adult, Disability Evaluation, Disease Progression, Female, Fingolimod Hydrochloride therapeutic use, Glatiramer Acetate therapeutic use, Humans, Immunosuppressive Agents therapeutic use, Interferon-beta therapeutic use, Longitudinal Studies, Male, Middle Aged, Multiple Sclerosis, Relapsing-Remitting physiopathology, Natalizumab therapeutic use, Proportional Hazards Models, Immunologic Factors therapeutic use, Multiple Sclerosis, Relapsing-Remitting drug therapy
- Abstract
Objective: To test the hypothesis that immunotherapy prevents long-term disability in relapsing-remitting multiple sclerosis (MS), we modeled disability outcomes in 14,717 patients., Methods: We studied patients from MSBase followed for ≥1 year, with ≥3 visits, ≥1 visit per year, and exposed to MS therapy, and a subset of patients with ≥15-year follow-up. Marginal structural models were used to compare the cumulative hazards of 12-month confirmed increase and decrease in disability, Expanded Disability Status Scale (EDSS) step 6, and the incidence of relapses between treated and untreated periods. Marginal structural models were continuously readjusted for patient age, sex, pregnancy, date, disease course, time from first symptom, prior relapse history, disability, and MRI activity., Results: A total of 14,717 patients were studied. During the treated periods, patients were less likely to experience relapses (hazard ratio 0.60, 95% confidence interval [CI] 0.43-0.82, p = 0.0016), worsening of disability (0.56, 0.38-0.82, p = 0.0026), and progress to EDSS step 6 (0.33, 0.19-0.59, p = 0.00019). Among 1,085 patients with ≥15-year follow-up, the treated patients were less likely to experience relapses (0.59, 0.50-0.70, p = 10
-9 ) and worsening of disability (0.81, 0.67-0.99, p = 0.043)., Conclusion: Continued treatment with MS immunotherapies reduces disability accrual by 19%-44% (95% CI 1%-62%), the risk of need of a walking aid by 67% (95% CI 41%-81%), and the frequency of relapses by 40-41% (95% CI 18%-57%) over 15 years. This study provides evidence that disease-modifying therapies are effective in improving disability outcomes in relapsing-remitting MS over the long term., Classification of Evidence: This study provides Class IV evidence that, for patients with relapsing-remitting MS, long-term exposure to immunotherapy prevents neurologic disability., (© 2020 American Academy of Neurology.)- Published
- 2021
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8. Treatment Response Score to Glatiramer Acetate or Interferon Beta-1a.
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Bovis F, Kalincik T, Lublin F, Cutter G, Malpas C, Horakova D, Havrdova EK, Trojano M, Prat A, Girard M, Duquette P, Onofrj M, Lugaresi A, Izquierdo G, Eichau S, Patti F, Terzi M, Grammond P, Bergamaschi R, Sola P, Ferraro D, Ozakbas S, Iuliano G, Boz C, Hupperts R, Grand'Maison F, Oreja-Guevara C, van Pesch V, Cartechini E, Petersen T, Altintas A, Soysal A, Ramo-Tello C, McCombe P, Turkoglu R, Butzkueven H, Wolinsky JS, Solaro C, and Sormani MP
- Subjects
- Adult, Cohort Studies, Databases, Factual trends, Female, Humans, Injections, Intramuscular, Male, Middle Aged, Treatment Outcome, Adjuvants, Immunologic administration & dosage, Glatiramer Acetate administration & dosage, Immunosuppressive Agents administration & dosage, Interferon beta-1a administration & dosage, Multiple Sclerosis, Relapsing-Remitting diagnosis, Multiple Sclerosis, Relapsing-Remitting drug therapy
- Abstract
Objective: To compare the effectiveness of glatiramer acetate (GA) vs intramuscular interferon beta-1a (IFN-β-1a), we applied a previously published statistical method aimed at identifying patients' profiles associated with efficacy of treatments., Methods: Data from 2 independent multiple sclerosis datasets, a randomized study (the Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis [CombiRx] trial, evaluating GA vs IFN-β-1a) and an observational cohort extracted from MSBase, were used to build and validate a treatment response score, regressing annualized relapse rates (ARRs) on a set of baseline predictors., Results: The overall ARR ratio of GA to IFN-β-1a in the CombiRx trial was 0.72. The response score (made up of a linear combination of age, sex, relapses in the previous year, disease duration, and Expanded Disability Status Scale score) detected differential response of GA vs IFN-β-1a: in the trial, patients with the largest benefit from GA vs IFN-β-1a (lower score quartile) had an ARR ratio of 0.40 (95% confidence interval [CI] 0.25-0.63), those in the 2 middle quartiles of 0.90 (95% CI 0.61-1.34), and those in the upper quartile of 1.14 (95% CI 0.59-2.18) (heterogeneity p = 0.012); this result was validated on MSBase, with the corresponding ARR ratios of 0.58 (95% CI 0.46-0.72), 0.92 (95% CI 0.77-1.09,) and 1.29 (95% CI 0.97-1.71); heterogeneity p < 0.0001)., Conclusions: We demonstrate the possibility of a criterion, based on patients' characteristics, to choose whether to treat with GA or IFN-β-1a. This result, replicated on an independent real-life cohort, may have implications for clinical decisions in everyday clinical practice., (© 2020 American Academy of Neurology.)
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- 2021
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9. Comment on "Controlling for Ascertainment Bias May Introduce Control Group Bias in Prospective Nonrandomized Trials".
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Gachabayov M, Dyatlov A, and Bergamaschi R
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- Bias, Control Groups, Double-Blind Method, Humans, Prospective Studies, Colonic Neoplasms
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- 2019
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10. A Succinct Critical Appraisal of Indications to Transanal Total Mesorectal Excision.
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Gachabayov M, Chudner A, and Bergamaschi R
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- Humans, Registries, Rectal Neoplasms, Transanal Endoscopic Surgery
- Published
- 2018
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11. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway.
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Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, and Fiore JF Jr
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- Fasting physiology, Humans, Perioperative Care trends, Societies, Medical trends, United States, Consensus, Nutritional Status physiology, Perioperative Care standards, Qualitative Research, Recovery of Function physiology, Societies, Medical standards
- Abstract
Perioperative malnutrition has proven to be challenging to define, diagnose, and treat. Despite these challenges, it is well known that suboptimal nutritional status is a strong independent predictor of poor postoperative outcomes. Although perioperative caregivers consistently express recognition of the importance of nutrition screening and optimization in the perioperative period, implementation of evidence-based perioperative nutrition guidelines and pathways in the United States has been quite limited and needs to be addressed in surgery-focused recommendations. The second Perioperative Quality Initiative brought together a group of international experts with the objective of providing consensus recommendations on this important topic with the goal of (1) developing guidelines for screening of nutritional status to identify patients at risk for adverse outcomes due to malnutrition; (2) address optimal methods of providing nutritional support and optimizing nutrition status preoperatively; and (3) identifying when and how to optimize nutrition delivery in the postoperative period. Discussion led to strong recommendations for implementation of routine preoperative nutrition screening to identify patients in need of preoperative nutrition optimization. Postoperatively, nutrition delivery should be restarted immediately after surgery. The key role of oral nutrition supplements, enteral nutrition, and parenteral nutrition (implemented in that order) in most perioperative patients was advocated for with protein delivery being more important than total calorie delivery. Finally, the role of often-inadequate nutrition intake in the posthospital setting was discussed, and the role of postdischarge oral nutrition supplements was emphasized.
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- 2018
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12. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Gastrointestinal Dysfunction Within an Enhanced Recovery Pathway for Elective Colorectal Surgery.
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Hedrick TL, McEvoy MD, Mythen MMG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, and Fiore JF Jr
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- Colorectal Surgery adverse effects, Consensus, Elective Surgical Procedures adverse effects, Elective Surgical Procedures trends, Gastrointestinal Diseases prevention & control, Humans, Perioperative Care methods, Postoperative Complications prevention & control, United States epidemiology, Colorectal Surgery trends, Gastrointestinal Diseases epidemiology, Perioperative Care standards, Postoperative Complications epidemiology, Recovery of Function physiology, Societies, Medical standards
- Abstract
The primary driver of length of stay after bowel surgery, particularly colorectal surgery, is the time to return of gastrointestinal (GI) function. Traditionally, delayed GI recovery was thought to be a routine and unavoidable consequence of surgery, but this has been shown to be false in the modern era owing to the proliferation of enhanced recovery protocols. However, impaired GI function is still common after colorectal surgery, and the current literature is ambiguous with regard to the definition of postoperative GI dysfunction (POGD), or what is typically referred to as ileus. This persistent ambiguity has impeded the ability to ascertain the true incidence of the condition and study it properly within a research setting. Furthermore, a rational and standardized approach to prevention and treatment of POGD is needed. The second Perioperative Quality Initiative brought together a group of international experts to review the published literature and provide consensus recommendations on this important topic with the goal to (1) develop a rational definition for POGD that can serve as a framework for clinical and research efforts; (2) critically review the evidence behind current prevention strategies and provide consensus recommendations; and (3) develop rational treatment strategies that take into account the wide spectrum of impaired GI function in the postoperative period.
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- 2018
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13. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Patient-Reported Outcomes in an Enhanced Recovery Pathway.
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Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr, Shaw AD, Thacker JKM, Gan TJ, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, and Grocott M
- Subjects
- Humans, Perioperative Care standards, Quality of Health Care standards, Quality of Life psychology, Societies, Medical standards, Consensus, Patient Reported Outcome Measures, Perioperative Care trends, Quality of Health Care trends, Recovery of Function physiology, Societies, Medical trends
- Abstract
Patient-reported outcomes (PROs) are measures of health status that come directly from the patient. PROs are an underutilized tool in the perioperative setting. Enhanced recovery pathways (ERPs) have primarily focused on traditional measures of health care quality such as complications and hospital length of stay. These measures do not capture postdischarge outcomes that are meaningful to patients such as function or freedom from disability. PROs can be used to facilitate shared decisions between patients and providers before surgery and establish benchmark recovery goals after surgery. PROs can also be utilized in quality improvement initiatives and clinical research studies. An expert panel, the Perioperative Quality Initiative (POQI) workgroup, conducted an extensive literature review to determine best practices for the incorporation of PROs in an ERP. This international group of experienced clinicians from North America and Europe met at Stony Brook, NY, on December 2-3, 2016, to review the evidence supporting the use of PROs in the context of surgical recovery. A modified Delphi method was used to capture the collective expertise of a diverse group to answer clinical questions. During 3 plenary sessions, the POQI PRO subgroup presented clinical questions based on a literature review, presented evidenced-based answers to those questions, and developed recommendations which represented a consensus opinion regarding the use of PROs in the context of an ERP. The POQI workgroup identified key criteria to evaluate patient-reported outcome measures (PROMs) for their incorporation in an ERP. The POQI workgroup agreed on the following recommendations: (1) PROMs in the perioperative setting should be collected in the framework of physical, mental, and social domains. (2) These data should be collected preoperatively at baseline, during the immediate postoperative time period, and after hospital discharge. (3) In the immediate postoperative setting, we recommend using the Quality of Recovery-15 score. After discharge at 30 and 90 days, we recommend the use of the World Health Organization Disability Assessment Scale 2.0, or a tailored use of the Patient-Reported Outcomes Measurement Information System. (4) Future study that consistently applies PROMs in an ERP will define the role these measures will have evaluating quality and guiding clinical care. Consensus guidelines regarding the incorporation of PRO measures in an ERP were created by the POQI workgroup. The inclusion of PROMs with traditional measures of health care quality after surgery provides an opportunity to improve clinical care.
- Published
- 2018
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14. A Nonsurgical Approach to Mesenteric Vascular Disease.
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Tabriziani H, Ahmad A, Narasimha D, Bergamaschi R, and Frishman WH
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- Disease Management, Embolectomy, Humans, Mesenteric Ischemia drug therapy, Mesenteric Ischemia surgery, Stents, Thrombectomy, Thrombolytic Therapy, Vasodilator Agents therapeutic use, Mesenteric Ischemia diagnosis, Vascular Surgical Procedures
- Abstract
Mesenteric ischemia is a rare disorder, with considerably high morbidity and mortality rates. It can manifest in several ways, including acute mesenteric ischemia, chronic mesenteric ischemia, nonocclusive mesenteric ischemia, mesenteric venous thrombosis, and colonic ischemia. Of these, acute mesenteric ischemia is the most severe form of intestinal ischemia, with a high mortality rate. The mainstay of therapy for mesenteric ischemia is surgical exploration and resection of infarcted bowel; however, medical therapy can play an important adjunctive role. When diagnosed early, before bowel infarction, endovascular therapy can be used as the primary treatment option. Endovascular therapy includes catheter-based thrombolysis, thromboembolectomy, and stenting. Vasodilators also play an important role in the early management of mesenteric ischemia. Anticoagulation is the main form of therapy in mesenteric venous thrombosis.
- Published
- 2018
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15. A Giant With Clay Feet.
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Bianco F, Romano G, Tsarkov P, Tulina I, and Bergamaschi R
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- Clay, Humans, Aluminum Silicates, Foot
- Published
- 2017
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16. Anti-inflammatory disease-modifying treatment and short-term disability progression in SPMS.
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Lorscheider J, Jokubaitis VG, Spelman T, Izquierdo G, Lugaresi A, Havrdova E, Horakova D, Trojano M, Duquette P, Girard M, Prat A, Grand'Maison F, Grammond P, Pucci E, Boz C, Sola P, Ferraro D, Spitaleri D, Lechner-Scott J, Terzi M, Van Pesch V, Iuliano G, Bergamaschi R, Ramo-Tello C, Granella F, Oreja-Guevara C, Butzkueven H, and Kalincik T
- Subjects
- Adult, Area Under Curve, Disability Evaluation, Disease Progression, Female, Follow-Up Studies, Humans, Longitudinal Studies, Magnetic Resonance Imaging, Male, Middle Aged, Multiple Sclerosis, Chronic Progressive diagnostic imaging, Propensity Score, Proportional Hazards Models, Recurrence, Treatment Outcome, Anti-Inflammatory Agents therapeutic use, Multiple Sclerosis, Chronic Progressive drug therapy
- Abstract
Objective: To investigate the effect of disease-modifying treatment on short-term disability outcomes in secondary progressive multiple sclerosis (SPMS)., Methods: Using MSBase, an international cohort study, we previously validated a highly accurate definition of SPMS. Here, we identified patients in MSBase who were either untreated or treated with a disease-modifying drug when meeting this definition. Propensity score matching was used to select subpopulations with comparable baseline characteristics. Disability outcomes were compared in paired, pairwise-censored analyses adjusted for treatment persistence, visit density, and relapse rates., Results: Of the 2,381 included patients, 1,378 patients were matchable (treated n = 689, untreated n = 689). Median pairwise-censored follow-up was 2.1 years (quartiles 1.2-3.8 years). No difference in the risk of 6-month sustained disability progression was observed between the groups (hazard ratio [HR] 0.9, 95% confidence interval [CI] 0.7-1.1, p = 0.27). We also did not find differences in any of the secondary endpoints: risk of reaching Expanded Disability Status Scale (EDSS) score ≥7 (HR 0.6, 95% CI 0.4-1.1, p = 0.10), sustained disability reduction (HR 1.0, 95% CI 0.8-1.3, p = 0.79), or change in disability burden (area under the EDSS-time curve, β = -0.05, p = 0.09). Secondary and sensitivity analyses confirmed the results., Conclusions: Our pooled analysis of the currently available disease-modifying agents used after conversion to SPMS suggests that, on average, these therapies have no substantial effect on relapse-unrelated disability outcomes measured by the EDSS up to 4 years., Classification of Evidence: This study provides Class IV evidence that for patients with SPMS, disease-modifying treatment has no beneficial effect on short-term disability progression., (© 2017 American Academy of Neurology.)
- Published
- 2017
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17. Comparative efficacy of first-line natalizumab vs IFN-β or glatiramer acetate in relapsing MS.
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Spelman T, Kalincik T, Jokubaitis V, Zhang A, Pellegrini F, Wiendl H, Belachew S, Hyde R, Verheul F, Lugaresi A, Havrdová E, Horáková D, Grammond P, Duquette P, Prat A, Iuliano G, Terzi M, Izquierdo G, Hupperts RM, Boz C, Pucci E, Giuliani G, Sola P, Spitaleri DL, Lechner-Scott J, Bergamaschi R, Grand'Maison F, Granella F, Kappos L, Trojano M, and Butzkueven H
- Abstract
Background: We compared efficacy and treatment persistence in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) initiating natalizumab compared with interferon-β (IFN-β)/glatiramer acetate (GA) therapies, using propensity score-matched cohorts from observational multiple sclerosis registries., Methods: The study population initiated IFN-β/GA in the MSBase Registry or natalizumab in the Tysabri Observational Program, had ≥3 months of on-treatment follow-up, and had active RRMS, defined as ≥1 gadolinium-enhancing lesion on cerebral MRI at baseline or ≥1 relapse within the 12 months prior to baseline. Baseline demographics and disease characteristics were balanced between propensity-matched groups. Annualized relapse rate (ARR), time to first relapse, treatment persistence, and disability outcomes were compared between matched treatment arms in the total population (n = 366/group) and subgroups with higher baseline disease activity., Results: First-line natalizumab was associated with a 68% relative reduction in ARR from a mean (SD) of 0.63 (0.92) on IFN-β/GA to 0.20 (0.63) ( p [signed-rank] < 0.0001), a 64% reduction in the rate of first relapse (hazard ratio [HR] 0.36, 95% confidence interval [CI] 0.28-0.47; p < 0.001), and a 27% reduction in the rate of discontinuation (HR 0.73, 95% CI 0.58-0.93; p = 0.01), compared with first-line IFN-β/GA therapy. Confirmed disability progression and area under the Expanded Disability Status Scale-time curve analyses were not significant. Similar relapse and treatment persistence results were observed in each of the higher disease activity subgroups., Conclusions: This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse and treatment persistence outcomes compared to first-line IFN-β/GA. This needs to be balanced against the risk of progressive multifocal leukoencephalopathy in natalizumab-treated patients., Classification of Evidence: This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse rates and treatment persistence outcomes compared to first-line IFN-β/GA.
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- 2016
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18. Duloxetine is effective in treating depression in multiple sclerosis patients: an open-label multicenter study.
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Solaro C, Bergamaschi R, Rezzani C, Mueller M, Trabucco E, Bargiggia V, Dematteis F, Mattioda A, Cimino V, Restivo D, Patti F, and Cavalla P
- Subjects
- Adrenergic Uptake Inhibitors adverse effects, Adult, Aged, Aged, 80 and over, Antidepressive Agents adverse effects, Diagnostic and Statistical Manual of Mental Disorders, Drug Monitoring, Duloxetine Hydrochloride, Fatigue etiology, Fatigue prevention & control, Female, Humans, Immunosuppressive Agents therapeutic use, Male, Middle Aged, Multiple Sclerosis drug therapy, Multiple Sclerosis physiopathology, Multiple Sclerosis, Relapsing-Remitting drug therapy, Multiple Sclerosis, Relapsing-Remitting physiopathology, Multiple Sclerosis, Relapsing-Remitting psychology, Nausea chemically induced, Patient Dropouts, Selective Serotonin Reuptake Inhibitors adverse effects, Thiophenes adverse effects, Adrenergic Uptake Inhibitors therapeutic use, Antidepressive Agents therapeutic use, Depression drug therapy, Multiple Sclerosis psychology, Selective Serotonin Reuptake Inhibitors therapeutic use, Thiophenes therapeutic use
- Abstract
Objectives: Duloxetine hydrochloride, a dual reuptake inhibitor of serotonin and norepinephrine, was evaluated for its therapeutic efficacy, safety, and tolerability in the treatment of depression in patients with multiple sclerosis (MS). Lifetime depression prevalence approaches 50% in MS patients. The aim of the study was to assess the safety and efficacy of duloxetine for treatment of depression in MS patients., Methods: An open-label study evaluated the efficacy of 12 weeks of duloxetine administration (maximal dose = 60 mg/d) in MS patients with clinical depression. The Beck scale score variation after 4 (T1) and 12 (T2) weeks of treatment was used for the primary outcome measurement, whereas secondary outcome was measured using the Modified Fatigue Impact Scale. Safety was evaluated by recording treatment-related adverse events, monitoring vital signs, and recording frequency and reasons for interruption or discontinuation of treatment., Results: Seventy-five patients were enrolled in the study. Sixty-three patients completed the study by continuing duloxetine treatment for 12 weeks (T2). Twelve subjects dropped out of the study because of adverse effects or noncompliance. Nausea was the most common adverse event reported. A significant reduction in the Beck Depression Inventory and Modified Fatigue Impact Scale scores, after both 4 and 12 weeks of therapy, was observed., Conclusions: The results suggest that duloxetine is well tolerated, safe, and effective in reducing depression and fatigue in MS patients.
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- 2013
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19. Postinfectious neurologic syndromes: a prospective cohort study.
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Marchioni E, Ravaglia S, Montomoli C, Tavazzi E, Minoli L, Baldanti F, Furione M, Alfonsi E, Bergamaschi R, Romani A, Piccolo L, Zardini E, Bastianello S, Pichiecchio A, Ferrante P, Delbue S, Franciotta D, Bono G, and Ceroni M
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Diagnosis, Differential, Encephalomyelitis, Acute Disseminated diagnosis, Encephalomyelitis, Acute Disseminated etiology, Female, Humans, Male, Middle Aged, Multiple Sclerosis diagnosis, Myelitis, Transverse diagnosis, Myelitis, Transverse etiology, Syndrome, Vaccines adverse effects, Young Adult, Infections complications, Nervous System Diseases diagnosis, Nervous System Diseases etiology
- Abstract
Objectives: Postinfectious neurologic syndromes (PINSs) of the CNS include heterogeneous disorders, sometimes relapsing. In this study, we aimed to a) describe the spectrum of PINSs; b) define predictors of outcome in PINSs; and c) assess the clinical/paraclinical features that help differentiate PINSs from multiple sclerosis (MS)., Methods: In this prospective cohort study, adult inpatients with PINSs underwent extensive diagnostic assessment and therapeutic protocols at inclusion and during a minimum 2-year follow-up. We compared them with newly diagnosed, treatment-naive patients with MS, also prospectively recruited., Results: The study sample comprised 176 patients with PINSs aged 59.9 ± 17.25 years (range: 18-80 years) divided into 2 groups: group 1 (CNS syndromes, 64%)-encephalitis, encephalomyelitis, or myelitis; and group 2 (CNS + peripheral nervous system [PNS] syndromes, 36%)-encephalomyeloradiculoneuritis or myeloradiculoneuritis. We observed the patients for 24 to 170 months (median 69 months). Relapses, almost invariably involving the spinal cord, occurred in 30.5%. PNS involvement was an independent risk factor for relapses (hazard ratio 2.8). The outcome was poor in 43% of patients; risk factors included older age, greater neurologic disability at onset, higher serum-CSF albumin percentage transfer, myelitis, and PNS involvement. Steroid resistance occurred in 30% of the patients, half of whom responded favorably to IV immunoglobulins. Compared with MS, PINSs were characterized by older age, lower tendency to relapse, and distinct CSF findings., Conclusions: The category of PINSs should be revised: most of the clinical variants have a poor prognosis and are not readily classifiable on the basis of current knowledge. PNS involvement has a critical role in relapses, which seem to affect the spine only.
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- 2013
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20. Acute myeloid leukemia in Italian patients with multiple sclerosis treated with mitoxantrone.
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Martinelli V, Cocco E, Capra R, Salemi G, Gallo P, Capobianco M, Pesci I, Ghezzi A, Pozzilli C, Lugaresi A, Bellantonio P, Amato MP, Grimaldi LM, Trojano M, Mancardi GL, Bergamaschi R, Gasperini C, Rodegher M, Straffi L, Ponzio M, and Comi G
- Subjects
- Aged, Female, Follow-Up Studies, Humans, Italy epidemiology, Male, Retrospective Studies, Statistics, Nonparametric, Analgesics adverse effects, Leukemia, Myeloid, Acute chemically induced, Mitoxantrone adverse effects, Multiple Sclerosis drug therapy
- Abstract
Objectives: To evaluate the incidence and dose-dependency of mitoxantrone (MTX)-associated acute myelocytic leukemia (AML) in the network of Italian multiple sclerosis (MS) clinics., Methods: We performed a multicenter retrospective cohort study of patients treated with MTX in MS centers under the Italian national health care system between 1998 and 2008. Demographic, disease, treatment, and follow-up information were collected using hospital records., Results: Data were available for 3,220 patients (63% women) from 40 Italian centers. Follow-up (mean ± SD) was 49 ± 29 months (range 12-140 months). We observed 30 cases of AML (incidence 0.93% [95% confidence interval 0.60%-1.26%]). The mean cumulative dose was higher in patients with AML (78 vs 65 mg/m(2), p = 0.028). The median interval from the start of therapy to AML diagnosis was longer than expected at 33 months (range 13-84 months); 8 patients (27%) developed AML 4 years or more after the first MTX infusion. The rate of mortality associated with AML was 37%., Conclusions: This higher than expected risk of AML and related mortality requires that treatment decisions must be made jointly between clinicians and patients who understand their prognosis, treatment options, and treatment-related risks. The now large exposed MS population must be monitored for hematologic abnormalities for at least 6 years from the end of therapy, to ensure the rapid actions needed for early diagnosis and treatment of AML.
- Published
- 2011
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21. Lymphocyte TRPV 1-4 gene expression and MIF blood levels in a young girl clinically diagnosed with HSAN IV.
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Bachiocco V, Bergamaschi R, Spinsanti G, Lima M, Romagnoli R, Sorda G, and Aloisi AM
- Subjects
- Adult, Cytokines metabolism, Enzyme-Linked Immunosorbent Assay methods, Female, Flow Cytometry methods, Humans, Male, Middle Aged, TRPV Cation Channels classification, TRPV Cation Channels metabolism, Young Adult, Gene Expression Regulation physiology, Hereditary Sensory and Autonomic Neuropathies blood, Hereditary Sensory and Autonomic Neuropathies genetics, Hereditary Sensory and Autonomic Neuropathies pathology, Intramolecular Oxidoreductases blood, Lymphocytes metabolism, Macrophage Migration-Inhibitory Factors blood, TRPV Cation Channels genetics
- Abstract
Objective: Patients with congenital insensitivity to pain are unable to sense pain and temperature. They undergo many injuries, inflammatory state, and infections. Various mutations in the neurotrophic tyrosine kinase receptor gene have been implicated in this disorder. We measured the leukocyte expression of transient receptor potential vanilloid (TRPV) 1-4 genes and the blood macrophage migration inhibitory factor (MIF) concentration in a young girl clinically diagnosed with congenital insensitivity to pain. The investigation may help to define the interplay between nerve growth factor and TRPV 1-4 channels and between these sensors and MIF in this disease, and in broader terms in nociception., Methods: TRPV 1-4 gene expression (real-time polymerase chain reaction) and MIF concentration (enzyme-linked immunosorbent assay) were determined in the blood of the girl, her family, and control participants. Statistical analysis of gene expression was carried out between samples and controls with a mathematical model based on the correction for exact polymerase chain reaction efficiencies, and the mean crossing point deviation between samples and controls., Results: The TRPV 1--4 gene expression rates did not significantly differ from the values found in the control group. TRPV1 was almost doubly upregulated. MIF levels were much higher than the reference value., Discussion: The high increase in the MIF concentration (likely due to the chronic or recurrent inflammatory state) may have contributed to the normal expression of TRPV 1-4 and to the relative upregulation of TRPV1. The role of this cytokine on the expression of these genes deserves further investigation.
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- 2011
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22. Robotic camera holder as good as expert camera holder: a randomized crossover trial.
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Uchal M, Haughn C, Raftopoulos Y, Hussain F, Reed JF, Tjugum J, and Bergamaschi R
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- Cross-Over Studies, Duodenal Diseases etiology, Equipment Design, Humans, Prospective Studies, Quality Assurance, Health Care methods, Rupture, Stomach Diseases etiology, Duodenal Diseases surgery, Robotics instrumentation, Stomach Diseases surgery, Suture Techniques instrumentation, Video Recording instrumentation
- Abstract
Introduction: This study aimed to compare the impact of robotic camera holder (RCH) and human camera holder (HCH) on product quality and procedure effectiveness of a simulated laparoscopic procedure., Methods: This was a prospective randomized crossover trial including voluntary surgical residents. Block randomization generated RCH-HCH or HCH-RCH sequence allocation. The task was suturing a duodenal perforation on foam stomach with intracorporeally knot tying in a simulator. The camera was operated by the same robot and same expert. Product quality was measured by accuracy error, tissue damage, sliding knot, and leak. Procedure effectiveness was measured by operating time, nongoal directed actions, and dangerous actions. Kendall's coefficient tau_b was used for interrater reliability between 2 blinded assessors., Results: Forty-four subjects performed their tasks as allocated. Product quality and procedure effectiveness were similar when first attempt of task was compared with the repeat task by same subject ignoring the type of camera holder. There was no evidence of significant unequal carryover effect when comparison was stratified by RCH-HCH or HCH-RCH sequences. There were no differences in product quality and procedure effectiveness when RCH was compared with HCH. Coefficient tau_b was > or = 0.80 for all but dangerous actions (0.72, P=0.08)., Conclusions: RCH and HCH had similar impact on product quality and procedure effectiveness of simulated laparoscopic procedure.
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- 2009
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23. Laparoscopic sigmoid resection for diverticulitis decreases major morbidity rates: a randomized control trial: short-term results of the Sigma Trial.
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Klarenbeek BR, Veenhof AA, Bergamaschi R, van der Peet DL, van den Broek WT, de Lange ES, Bemelman WA, Heres P, Lacy AM, Engel AF, and Cuesta MA
- Subjects
- Adult, Aged, Aged, 80 and over, Double-Blind Method, Female, Humans, Male, Middle Aged, Prospective Studies, Time Factors, Diverticulitis surgery, Laparoscopy, Postoperative Complications epidemiology, Postoperative Complications prevention & control, Sigmoid Diseases surgery
- Abstract
Background: No randomized controlled trial has compared laparoscopic sigmoid resection (LSR) to open sigmoid resection (OSR) for symptomatic diverticulitis of the sigmoid colon. This study tested the hypothesis that LSR is associated with decreased postoperative complication rates as compared with OSR., Methods: This was a prospective, multicenter, double-blind, parallel-arm, randomized controlled trial. Eligible patients were randomized to either LSR or OSR. Endpoints included postoperative mortality, and complications were classified as major and minor. The generator of the allocation sequence was separated from the executor. Blinding was ensured using an opaque wound dressing to cover the abdomen. Symptomatic diverticulitis of the sigmoid colon was defined as recurrent disease Hinchey I, IIa, IIb, symptomatic stricture, or severe rectal bleeding. The decision to discharge patients was made by independent physicians blind to the allocation sequence. Data were analyzed according to the intention to treat principle., Results: From 2002 to 2006, 104 patients were randomized in 5 centers. All patients underwent the allocated intervention. Fifty-two LSR patients were comparable to 52 OSR patients for gender, age, BMI, ASA grade, comorbid conditions, previous abdominal surgery, and indication for surgery. LSR took longer (P = 0.0001) but caused less blood loss (P = 0.033). Conversion rate was 19.2%. Mortality rate was 1%. There were significantly more major complications in OSR patients (9.6% vs. 25.0%; P = 0.038). Minor complication rates were similar (LSR 36.5% vs. OSR 38.5%; P = 0.839). LSR patients had less pain (Visual Analog Scale 1.6; P = 0.0003), systemic analgesia requirement (P = 0.029), and returned home earlier (P = 0.046). The short form-36 questionnaire showed significantly better quality of life for LSR., Conclusions: LSR was associated with a 15.4% reduction in major complication rates, less pain, improved quality of life, and shorter hospitalization at the cost of a longer operating time.
- Published
- 2009
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24. Occurrence of CNS demyelinating disease in patients with myasthenia gravis.
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Kister I, Herbert J, Swerdlow ML, Bergamaschi R, Piccolo G, and Oger J
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- Autoantibodies blood, Autoantibodies immunology, Diagnosis, Differential, Humans, Myasthenia Gravis immunology, Myasthenia Gravis physiopathology, Myelitis, Transverse diagnosis, Myelitis, Transverse immunology, Myelitis, Transverse physiopathology, Neuromyelitis Optica physiopathology, Optic Nerve immunology, Optic Nerve pathology, Optic Nerve physiopathology, Postoperative Complications physiopathology, Postoperative Complications prevention & control, Predictive Value of Tests, Self Tolerance immunology, Spinal Cord immunology, Spinal Cord pathology, Spinal Cord physiopathology, Autoantibodies analysis, Myasthenia Gravis complications, Neuromyelitis Optica diagnosis, Neuromyelitis Optica immunology, Postoperative Complications immunology, Thymectomy adverse effects
- Published
- 2007
25. NMO-IgG in the diagnosis of neuromyelitis optica.
- Author
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Jarius S, Franciotta D, Bergamaschi R, Wright H, Littleton E, Palace J, Hohlfeld R, and Vincent A
- Subjects
- Animals, Biomarkers blood, Brain blood supply, Brain immunology, Diagnosis, Differential, Fluorescent Antibody Technique, Humans, Mice, Microcirculation cytology, Microcirculation immunology, Multiple Sclerosis blood, Multiple Sclerosis diagnosis, Multiple Sclerosis immunology, Neuromyelitis Optica blood, Predictive Value of Tests, Recurrence, Autoantibodies blood, Immunoglobulin G blood, Neuromyelitis Optica diagnosis, Neuromyelitis Optica immunology
- Published
- 2007
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26. Grading cervical cord damage in neuromyelitis optica and MS by diffusion tensor MRI.
- Author
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Benedetti B, Valsasina P, Judica E, Martinelli V, Ghezzi A, Capra R, Bergamaschi R, Comi G, and Filippi M
- Subjects
- Adult, Analysis of Variance, Anisotropy, Case-Control Studies, Disability Evaluation, Female, Humans, Image Processing, Computer-Assisted, Male, Middle Aged, Statistics as Topic, Diffusion Magnetic Resonance Imaging, Multiple Sclerosis pathology, Neuromyelitis Optica pathology, Spinal Cord pathology
- Abstract
The authors assessed the ability of diffusion tensor MRI to grade cervical cord damage in 10 patients with neuromyelitis optica, 10 patients with multiple sclerosis, and 10 healthy controls. The three groups differed in terms of average mean diffusivity (p = 0.008) and average fractional anisotropy (p = 0.04). There was a correlation between the Expanded Standard Disability Status Scale score and cord average mean diffusivity (r = 0.52, p = 0.02).
- Published
- 2006
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27. Magnetization transfer and diffusion tensor MRI show gray matter damage in neuromyelitis optica.
- Author
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Rocca MA, Agosta F, Mezzapesa DM, Martinelli V, Salvi F, Ghezzi A, Bergamaschi R, Comi G, and Filippi M
- Subjects
- Adult, Aged, Female, Humans, Male, Middle Aged, Myelin Sheath pathology, Single-Blind Method, Brain pathology, Magnetic Resonance Imaging methods, Neuromyelitis Optica pathology
- Abstract
Using magnetization transfer (MT) and diffusion tensor (DT) MRI, the authors assessed the extent of tissue damage of the brain normal-appearing white and gray matter (NAGM) in patients with neuromyelitis optica (NMO). Compared to healthy controls, patients with NMO showed reduced MT ratio and increased mean diffusivity of the NAGM. This challenges the classic notion of a sparing of the brain tissue in the course of NMO.
- Published
- 2004
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28. Preserving the superior rectal artery in laparoscopic sigmoid resection for complete rectal prolapse.
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Bergamaschi R, Lovvik K, and Marvik R
- Subjects
- Adult, Aged, Aged, 80 and over, Anastomosis, Surgical adverse effects, Colectomy methods, Colon, Sigmoid surgery, Female, Humans, Laparoscopy methods, Male, Middle Aged, Prospective Studies, Surgical Wound Dehiscence etiology, Colectomy adverse effects, Colon, Sigmoid blood supply, Mesenteric Artery, Inferior surgery, Rectal Prolapse surgery
- Abstract
Sigmoid resection is indicated in the treatment of complete rectal prolapse (CRP) in patients with prolonged colorectal transit time (CTT). Its use, however, has been limited because of fear of anastomotic leakage. This study challenges the current practice of dividing the mesorectum by prospectively evaluating the impact of sparing the superior rectal artery (SRA) on leak rates after laparoscopic sigmoid resection (LSR) for CRP. During a 30-month period, data on 33 selected patients with CRP were prospectively collected. Three patients were withdrawn from the analysis, as they had neither resection nor anastomosis. Twenty-nine women and 1 man (median age 55 range 21-83 years) underwent LSR with preservation of SRA for a median CRP of 8 (3-15) cm. There were 20 ASA I and 10 ASA II patients. Ten patients had undergone previous surgery. Four patients complained of dyschezia, whereas incontinence was present in 26 patients. Anal ultrasound showed isolated internal sphincter defects in 2 patients. Four young adults (21-32 years) had normal CTT, whereas 26 older patients had a median CTT of 5(4-6) days. Defecography demonstrated 10 enteroceles, two sigmoidoceles, and one rectal hernia through the levator ani muscle. Mortality was nil. Median operating room time was 180 (120-330) min, suprapubic incision length 5(3-7) cm, estimated blood loss 150 (50-500) mL, specimen length 20 (12-45) cm, solid food resumption 3(1-6) days, and length of stay 4.5(2-7) days. Thirty-day complications were not related to anastomosing and occurred in 20% of the patients. Median follow-up was 34.1 (18-48) months. One patient had a recurrence. Although the evidence provided by the present study suggests that sparing SRA has a favorable impact on anastomotic leak rates, these nonrandomized results need further evaluation. The division of the mesorectum at the rectosigmoid junction seems not necessary, and its sparing should therefore be considered as it may contain anastomotic leak rates.
- Published
- 2003
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29. Recurrence rates at minimum 5-year follow-up: laparoscopic versus open sigmoid resection for uncomplicated diverticulitis.
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Thaler K, Weiss EG, Nogueras JJ, Arnaud JP, Wexner SD, and Bergamaschi R
- Subjects
- Aged, Female, Follow-Up Studies, Humans, Laparoscopy, Male, Middle Aged, Recurrence, Retrospective Studies, Treatment Outcome, Colectomy methods, Diverticulitis, Colonic physiopathology, Diverticulitis, Colonic surgery, Sigmoid Diseases physiopathology, Sigmoid Diseases surgery
- Abstract
The aim of the study was to compare the impact of surgical access to sigmoid resection on recurrence rates in patients with uncomplicated diverticulitis of the sigmoid (UDS) at a minimum follow-up of 5 years. Recurrence after surgery was defined as left lower quadrant pain, fever, and leucocytosis with consistent CT and enema findings on admission and at 6 weeks, respectively. Outcome measures included splenic flexure mobilization, specimen length, inflammation at proximal resection margin, and presence of teniae coli at distal resection margin. Seventy-nine patients undergoing laparoscopic sigmoid resection (LSR) were compared with 79 matched controls with open sigmoid resection (OSR) operated on at 2 institutions during the same period. Patients were well matched for age, gender, body mass index, ASA grading, and symptoms duration, but not for follow-up length (81.9 versus 86.9 months, P = 0.046). Differences in rates of splenic flexure mobilization (19 versus 41, P < 0.001), specimen length (16.1 versus 18.3 cm, P = 0.048), inflammation at proximal resection margin (21 versus 4, P < 0.001), and teniae coli at distal resection margin (4 versus 53, P < 0.001) did not show an impact on recurrence rates when comparison was made between LSR and OSR. Three LSR patients and 7 OSR patients had 1 recurrence (P = 0.19). There were no significant differences in rates of flexure mobilization, specimen length, and rates of inflammation present at proximal resection margin in 10 recurring and 145 non-recurring patients. The rate of teniae coli present at distal resection margin was significantly increased in recurring patients (7 versus 43, P = 0.03). Median time of recurrence after surgery was 29 (range 18-74) months. Two of 11 recurrences occurred after 5 years. Surgical access to sigmoid resection for UDS is unlikely to have an impact on recurrence rates provided that the oral bowel end is anastomosed to the proximal rectum rather than to the distal sigmoid.
- Published
- 2003
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30. Laparoscopic antiperistaltic versus isoperistaltic gastrojejunostomy for palliation of gastric outlet obstruction in advanced cancer.
- Author
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Bergamaschi R, Arnaud JP, Mårvik R, and Myrvold HE
- Subjects
- Aged, Female, Gastric Outlet Obstruction etiology, Humans, Male, Middle Aged, Palliative Care, Patient Readmission, Postoperative Complications, Treatment Outcome, Gastric Outlet Obstruction surgery, Gastrostomy methods, Jejunostomy methods, Stomach Neoplasms complications
- Abstract
The purpose of the study was to compare the impact of the peristaltic orientation of laparoscopic gastrojejunal anastomoses (LGJ) in patients with malignant gastric outlet obstruction (GOO) on postoperative delayed-return gastric emptying (DRGE) rates. GOO was defined as complete holdup of contrast at barium meal and/or failure of gastroscope to pass beyond stricture. DRGE was defined as inability to eat regular diet by day 10. Thirty-four patients undergoing antiperistaltic LGJ were compared with 21 patients undergoing isoperistaltic LGJ at two institutions during the same period. Thirty-day mortality was 5.4%, and median survival was 6.2 months. Thirty-day morbidity was 20%, and conversion rate was 3.6%. DRGE rates were increased after isoperistaltic LGJ (0 vs. 3; P < 0.05), but patient groups were not well matched for type of primary cancer (P < 0.05). All patients with DRGE resumed food intake 12 to 16 days after surgery. There were 21 admissions before death, with a reoperation rate of 11.5% and a recurrent GOO rate of 3.8%. Although no conclusions could be drawn about whether the peristaltic orientation of the anastomosis had a bearing on DRGE rates, LGJ resulted in an overall 6% rate of DRGE.
- Published
- 2002
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31. Laparoscopic cholecystectomy in cirrhotic patients.
- Author
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Tuech JJ, Pessaux P, Regenet N, Rouge C, Bergamaschi R, and Arnaud JP
- Subjects
- Adult, Aged, Comorbidity, Female, Humans, Male, Middle Aged, Cholecystectomy, Laparoscopic, Cholelithiasis epidemiology, Cholelithiasis surgery, Liver Cirrhosis epidemiology
- Abstract
Since 1992, laparoscopic cholecystectomy has been the treatment of choice for symptomatic gallstones. The advantages of laparoscopic cholecystectomy for most patients have been extensively published. However, its benefits and successful use in patients with cirrhosis are less well documented. The aim of this study was to determine the efficacy and safety of laparoscopic cholecystectomy in cirrhotic patients. We did a retrospective review of the records of 26 consecutive laparoscopic cholecystectomy procedures performed on cirrhotic patients between January 1992 and September 2000. Twenty-two patients were classified as having Child's class A cirrhosis, and 4 patients were classified as having Child's class B. No patients were classified as having Child's class C cirrhosis. There were 20 men and 6 women, with a mean age of 57 years (range, 37-76). All procedures were completed laparoscopically. There was histologic confirmation of cirrhosis in all patients. The mean operative time was 126 minutes (range, 60-184). The mean estimated blood loss was 110 mL (range, 40-380). Complications occurred in 7 patients (27%). No operative mortality occurred in this study. The mean length of hospital stay was 5 days (range, 3-14). Our results and the results of others show that laparoscopic cholecystectomy in cirrhotic patients seems to be safe in selected Child-Pugh class A and B patients with compensated cirrhosis. Cholecystectomy remains a high-risk procedure in cirrhotic patients, and indications for cholecystectomy should be evaluated carefully. Controlled trials are required to confirm the safety of this procedure, and further studies are also required to evaluate the management of gallbladder disease in patients with Child-Pugh class C cirrhosis.
- Published
- 2002
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32. Laparoscopic suture closure of perforated duodenal peptic ulcer.
- Author
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Arnaud JP, Tuech JJ, Bergamaschi R, Pessaux P, and Regenet N
- Subjects
- Aged, Female, Humans, Male, Omentum surgery, Peritoneal Lavage methods, Treatment Outcome, Duodenal Ulcer surgery, Laparoscopy methods, Peptic Ulcer Perforation surgery, Sutures
- Abstract
The aim of this study was to assess the outcome of a continuous series of 30 patients with perforated duodenal peptic ulcers treated by a laparoscopic approach. Between January 1996 and December 1998, 30 patients (24 males, 6 females) with a mean age of 69.2 years were operated on with a laparoscopic approach. Laparoscopic treatment included peritoneal lavage, suture of the perforation, and omental patching in 24 cases. A conversion to laparotomy was necessary in five patients (16.6%). Mean operative time was 92 minutes (range: 58-114) and mean hospital stay was 6 days (range: 4-16). Mortality and morbidity rates were 6.6% (n = 2) and 16.6% (n = 5). With a median follow-up of 12 months, 96% of the patients were in good condition; one patient had recurrent duodenal ulceration. The results of our study show the feasibility of the laparoscopic approach for perforated peptic ulcer repair, with acceptable mortality and morbidity rates.
- Published
- 2002
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33. Laparoscopic versus open cholecystectomy: a prospective comparative study in the elderly with acute cholecystitis.
- Author
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Pessaux P, Regenet N, Tuech JJ, Rouge C, Bergamaschi R, and Arnaud JP
- Subjects
- Acute Disease, Aged, Aged, 80 and over, Chi-Square Distribution, Cholecystectomy, Laparoscopic, Feasibility Studies, Female, Humans, Male, Prospective Studies, Cholecystectomy methods, Cholecystitis surgery
- Abstract
The aim of this prospective comparative study was to determine the feasibility and the efficacy of laparoscopic cholecystectomy for acute cholecystitis in patients older than 75 years of age and to compare the results with those of open cholecystectomy. From January 1992 to December 1999, 139 patients older than 75 years of age underwent cholecystectomy for acute cholecystitis. The two groups of patients with cholecystolithiasis included 50 patients who underwent laparoscopic cholecystectomy (group 1) and 89 patients who underwent open cholecystectomy (group 2). Group 1 consisted of 30 women and 20 men, with a mean age of 81.9 years (range, 75-98). Group 2 consisted of 51 women and 38 men, with a mean age of 81.9 years (range, 75-93). There was no difference in the American Society of Anesthesiologists classification in both groups. The length of the surgery (103.3 vs. 149.7 minutes), postoperative length of stay (7.7 vs. 12.7 days), and inpatient rehabilitation (15 vs. 42 patients) were significantly shorter in group 1 than in group 2. The postoperative morbidity rate was not different between the groups. There was no mortality in group 1, but four patients died in group 2 (P = 0.29). The conversion rate was 32% (n = 16) in group 1. In summary, laparoscopic cholecystectomy in elderly patients with acute cholecystitis is safe and effective. Laparoscopic cholecystectomy in elderly patients restores them to the best possible quality of life with the lowest cost to them physiologically.
- Published
- 2001
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34. Instruction versus passive observation: a randomized educational research study on laparoscopic suture skills.
- Author
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Bergamaschi R and Dicko A
- Subjects
- Humans, Clinical Competence, Laparoscopy, Psychomotor Performance, Suture Techniques
- Abstract
Implementing laparoscopic surgery is a challenge that should prompt educational research in an attempt to establish a link between instruction and the quality of patient care. This randomized study was undertaken to compare the impact of instruction versus passive observation on laparoscopic skills. The task was stitching and tying a surgeon's knot on a perforated ulcer in a foam stomach placed in a simulator. Outcome measures were accuracy error, goal-directed and non-goal-directed actions, operating time, and tissue damage. Time/motion analysis was carried out by an masked assessor. Twelve participants were well matched for hand-eye coordination at pretesting. Regardless of whether instruction was given or not, a positive correlation was found between overall actions and operating time, non-goal-directed actions and operating time, and overall actions and non-goal directed actions. Intraoperative instruction decreased errors, but this study did not have sufficient power to detect small differences in other outcome measures. The teaching of minimal-access surgery should increasingly be based on educational research data rather than on unstructured rating by attending surgeons.
- Published
- 2000
35. Anatomic rationale for arterial bleeding from the liver bed during and/or after laparoscopic cholecystectomy: a postmortem study.
- Author
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Bergamaschi R and Ignjatovic D
- Subjects
- Adult, Aged, Aged, 80 and over, Cadaver, Cholecystectomy, Laparoscopic methods, Female, Humans, Liver anatomy & histology, Liver Circulation, Liver Diseases diagnosis, Male, Middle Aged, Postoperative Hemorrhage diagnosis, Sensitivity and Specificity, Cholecystectomy, Laparoscopic adverse effects, Hepatic Artery anatomy & histology, Intraoperative Complications etiology, Liver blood supply, Liver Diseases etiology, Postoperative Hemorrhage etiology
- Abstract
The aim of this study was to establish an anatomic rationale for liver bed arterial bleeding during laparoscopic cholecystectomy. Fifty consecutive human cadavers were dissected. A corrosion cast method was used. Six anastomotic branches (12%) of the cystic artery to the right or left hepatic artery ran underneath the gallbladder serosa surface and entered liver parenchyma after crossing the medial or lateral edge of the liver fossa without passing through the areolar tissue of the liver bed. Their mean length was 18.3 mm (range 4-60), and the mean diameter was 0.38 mm (range 0.2-0.8). Two cystic arteries that ascended in the midline between the gallbladder and liver bed were identified in 50 (4%) casts. Their lengths were 16 and 18 mm, and their diameters were 1.9 and 2.2 mm. Five and seven branches encircling the gallbladder arose radially. These two arterial branching patterns can cause arterial bleeding from the liver bed during and/or after laparoscopic cholecystectomy.
- Published
- 1999
36. Magnetization transfer imaging of patients with definite MS and negative conventional MRI.
- Author
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Filippi M, Rocca MA, Minicucci L, Martinelli V, Ghezzi A, Bergamaschi R, and Comi G
- Subjects
- Adolescent, Adult, Brain pathology, Female, Humans, Male, Middle Aged, Magnetic Resonance Imaging methods, Multiple Sclerosis pathology
- Abstract
Objective: To assess, in a group of patients with clinically or laboratory-supported definite MS and negative conventional MRI scans of the brain, whether magnetization transfer imaging (MTI) is able to detect subtle white matter changes., Background: MTI of the brain in patients with MS frequently demonstrates the presence of microscopic damage to white matter, which appears normal on conventional MRI., Methods: Brain MRI and MTI scans were obtained from 11 patients with negative conventional MRIs of the brain, selected from 618 clinically or laboratory-supported definite MS cases scanned in the last 2 years in three Italian MS centers., Results: Compared with control subjects, patients had significantly lower mean MT ratios (MTR) in the pons, cerebellum, and periventricular regions. The percentages of pixels with MTR values below 1, 2, and 3 SD of the mean MTR value of the control subjects were 7.6% (range, 3.2% to 11.8%), 5.2% (range, 2.0% to 8.5%), and 3.6% (range, 1.2% to 6.1%), respectively. They were mainly located in the white matter of the centra semiovalia, and usually were isolated., Conclusions: MTI can detect white matter abnormalities in patients with MS and negative conventional brain MRI scans. The detection of such abnormalities may increase diagnostic confidence in those cases where MS is clinically suspected, but conventional MRI does not suggest the diagnosis.
- Published
- 1999
- Full Text
- View/download PDF
37. MRI and brainstem auditory evoked potential evidence of eighth cranial nerve involvement in multiple sclerosis.
- Author
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Bergamaschi R, Romani A, Zappoli F, Versino M, and Cosi V
- Subjects
- Adult, Female, Hearing Disorders etiology, Humans, Multiple Sclerosis complications, Evoked Potentials, Auditory, Brain Stem, Magnetic Resonance Imaging, Multiple Sclerosis pathology, Multiple Sclerosis physiopathology, Vestibulocochlear Nerve pathology, Vestibulocochlear Nerve physiopathology
- Abstract
An MS patient experienced sudden hearing loss. Brainstem auditory evoked potentials, previously normal, showed substantial abnormalities that suggested the impairment of the distal part of the acoustic nerve. MRI detected a small hyperintense lesion along the acoustic nerve; the lesion decreased in size and then disappeared after steroid treatment. This demonstrates that a demyelinating lesion in the distal tract of the eighth cranial nerve may cause an acute hearing loss in MS.
- Published
- 1997
- Full Text
- View/download PDF
38. Ataxia-telangiectasia: MR and CT findings.
- Author
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Farina L, Uggetti C, Ottolini A, Martelli A, Bergamaschi R, Sibilla L, Zappoli F, Egitto MG, and Lanzi G
- Subjects
- Adolescent, Adult, Ataxia Telangiectasia pathology, Atrophy, Cerebellar Ataxia pathology, Cerebellum diagnostic imaging, Cerebellum pathology, Cerebral Ventricles pathology, Child, Child, Preschool, Dilatation, Pathologic diagnostic imaging, Dilatation, Pathologic pathology, Double-Blind Method, Eye Diseases pathology, Female, Humans, Lung Diseases microbiology, Male, Skin Diseases, Vascular pathology, Ataxia Telangiectasia diagnosis, Ataxia Telangiectasia diagnostic imaging, Brain diagnostic imaging, Brain pathology, Magnetic Resonance Imaging, Tomography, X-Ray Computed
- Abstract
Objective: The aim of our study was to describe the neuroradiologic features of 12 patients with ataxia-telangiectasia (A-T), a degenerative multisystemic autosomal recessive hereditary disorder with onset in childhood. Clinical features include cerebellar ataxia, oculocutaneous telangiectasias, and recurrent bronchopulmonary infections. Patients present varying states of immunodeficiency and a high incidence of neoplasms. Chromosomal instability with a rearrangement of chromosomes 7 and 14 is always present., Materials and Methods: We describe the neuroradiological findings (10 MR and 2 CT) in 12 subjects: 11 with A-T and 1 heterozygote parent., Results: The images revealed a diffuse cerebellar atrophy, with marked involvement of the vermis and unusual decreased thickness of the superior cortex of the cerebellar hemispheres. Hypoplasia of the inferior vermis and a large cisterna magna were also frequent signs., Conclusion: Magnetic resonance is the technique of choice in this type of disorder since it permits better visualization of the posterior fossa structures.
- Published
- 1994
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