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临床试验/NCT01041079
NCT01041079已完成不适用

Laparoscopic Revision Gastric Bypass Surgery for Chronic Marginal Ulcers: a 10 Year Experience

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Morbidity and mortality

研究概览

简要总结

The purpose of this study is to determine the feasibility, safety, and efficacy of revision gastroplasty along with other adjunct procedures in the treatment of intractable / chronic marginal ulcers after Roux-en-Y gastric bypass. A secondary aim is the identification of good and poor outcome predictors after revisional strategies for intractable or chronic marginal ulcer.

详细描述

The epidemic of overweight and obesity in the United States of America along with its comorbidities continues to expand. Bariatric surgery has demonstrated to be the most effective and sustained method to control severe obesity and its comorbidities. For instance, type 2 diabetes mellitus was completely resolved in 76.8%, systemic arterial hypertension was resolved in 61.7%, dyslipidemia improved in 70% and obstructive sleep apnea-hypopnea syndrome was resolved in 85.7%. Furthermore, bariatric surgery significantly increases life expectancy (89%) and decreases overall mortality (30-40%), particularly deaths from diabetes, heart disease, and cancer. Lastly, preliminary evidence about downstream savings associated with bariatric surgery offset the initial costs in 2 to 4 years.

Since 1998, there has been a substantially progressive increase in bariatric surgery. In 2005, the ASMBS reported that 81% of bariatric procedures were approached laparoscopically and in 2007, 205,000 people had bariatric surgery in the United States from which approximately 80% of these were Gastric Bypass. Moreover, there is a mismatch between eligibility and receipt of bariatric surgery with just less than 1% of the eligible population being treated for morbid obesity through bariatric surgery. Along with the increasing number of elective primary weight loss procedures, up to 20% of post RYGB patients cannot sustain their weight loss beyond 2 to 3 years after the primary bariatric procedure. Thus, revisional surgery for poor weight loss and re-operations for technical or mechanical complications will rise in a parallel manner.

A common late complication after gastric bypass surgery is marginal ulceration, an ulcer at the margins of the gastrojejunostomy on the jejunal side. Its incidence after RYGB ranges from as low as 0.6 to as high as 16%. After 1,040 laparoscopic RYGB surgeries, the incidence rate, in our hands, is 1.4% and mainly related to NSAID´s use. In observational cohort studies, the presence of specific technical factors - staple-line dehiscence or gastro-gastric fistula, enlarged pouch, foreign material and local ischemia - and environmental factors - tobacco, NSAID´s, alcohol consumption, and H pylori infection among others - have been associated with marginal ulceration however the exact etiopathogenesis has not been completely elucidated.

Similar to peptic ulcer disease (PUD), most marginal ulcers respond to medical therapy, specifically sucralfate and acid-lowering medication. In contrast, when perforation, obstruction, penetration, bleeding and/or intractability presents, complex or complicated ulcer disease, warrants surgical intervention.

The intestinal mucosa is not typically exposed to gastric acid, which is neutralized by the alkaline biliopancreatic secretions. The jejunal mucosa has no natural barriers; when exposed to gastric acid, it ulcerates easily. Capella & Capella demonstrated that transecting the gastric segments significantly reduce staple-line dehiscence; this is the so-called divided gastric bypass. In the retrospective analysis of their consecutive series, the incidence for gastro-gastric fistula (GGF) formation after undivided gastric bypass (GBP) was 23%, after a partially divided GBP was 19%, after a completely divided GBP was 2% and after complete transection with interposition of the jejunal limb was 0% (p <0.001). MacLean et al confirmed that divided primary gastric bypass decreases GGF formation (29% vs. 3%). Also, patients who developed marginal ulcers had a lower pH as well as a greater time with a pH less than 2 correlating 100% with the presence of GGF; closure of the GGF increased the pH in the pouch with subsequent healing of the marginal ulcer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic/Intractable, either recurrent or persistent, marginal ulcers after Roux-en-Y gastric bypass surgery for clinically severe obesity

排除标准

  • Chronic or Intractable marginal ulcer after other bariatric procedures
  • Revision or re-operation by open approach
  • missing records and/or unreachable patients with scant information for analysis

结局指标

主要结局

Morbidity and mortality

时间窗: at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 4 years

Weight loss expressed as Body Mass Index and Percentage excess weight loss

时间窗: at 6 months, 1 year and annually thereafter for up to 4 years

Remission or improvement of marginal ulcer-related symptoms

时间窗: at 6 months, 1 year and annually thereafter for up to 4 years

Remission or improvement of comorbidities

时间窗: at 6 months, 1 year and annually thereafter for up to 4 years

次要结局

  • Length of operative time which is defined as the time duration of operation measured in minutes from the first skin incision to the final closure of the skin incision(It is measured in minutes from the first skin incision to the final closure of the skin incision at the time of revisional surgery under study. It is a transoperative measure of outcome of the surgery under study)
  • Length of Hospital Stay which is a measured of surgical recovery quantified and reported in days. It is a hospital pre-discharge traditional measure of outcome.(It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study.)

研究者

申办方类型
Other

研究点 (1)

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