跳至主要内容
临床试验/NCT01040481
NCT01040481已完成不适用

Laparoscopic Revisional Surgery: Adding Malabsorption for Failed Gastric Bypass

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2009年8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
19
试验地点
1
主要终点
Morbidity and mortality

研究概览

简要总结

The main aim of this study is to analyze and report the preliminary and intermediate term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for weight recidivism. The foremost outcome measurements are 1) Fat loss mainly measured as weight loss and expressed as trends in BMI, %EWL, and/or %EBL; 2) Trend in Comorbidity status; and 3) Patient satisfaction and Health-Related Quality of Life "HR-QoL" measured by a standardized, non-validated subjective satisfaction questionnaire and the validated, disease-specific, Moorehead-Ardelt II QoL questionnaires, respectively; 4) Morbidity & Mortality including nutritional status and metabolic complications.

Consequently, secondary objectives of this study are 1) to assess failure rate defined as percentage of excess weight loss < 50% , lowest BMI >35 for morbidly obese (MO) or >40 for superobese (SO), and/or lack of resolution/improvement of major comorbidities at the point in time when assessing preliminary and intermediate results after the surgery under analysis. 2) To evaluate the metabolic and nutritional status by measurements of particular clinical and biochemical parameters.

This research is in line with the most current provocative new ideas and recent high impact publications. To the best of our knowledge, this is the very first outcome study of revisional malabsorptive distal gastric bypass surgery by laparoscopy with diverse revisional strategies such as revisional gastroplasty, revisional Fobi-Capella, revisional Adjustable Gastric Band, conversion to distal, and conversion to very, very long limb gastric bypass. Previously, several studies have addressed conversion to malabsorptive gastric bypass after a failed primary proximal gastric bypass but none has addressed the failed distal gastric bypass nor the adequate balance between increasing restriction and malabsorption for decreasing the risk of protein-calorie malnutrition.

详细描述

Since 1998, there has been a substantially progressive increase in bariatric surgery. In 2005, the American Society of Metabolic and Bariatric Surgery (ASMBS) reported that 81% of bariatric procedures were approached laparoscopically. 205,000 people, in 2007, 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 procedure11. Thus, revisional surgery for poor weight loss and re-operations for technical or mechanical complications will rise in a parallel manner. RYGB is consistently considered the revisional procedure of choice for failed restrictive procedures.

At present there are three broad categories of bariatric procedures according to its mechanism of action: 1) purely restrictive, 2) primarily restrictive with some malabsorption, and 3) primarily malabsorptive with some restriction. Modern standard bariatric procedures recognized by the American Society for Metabolic and Bariatric Surgery "ASMBS" include the following 1) adjustable gastric band, 2) sleeve gastrectomy, 3) gastric bypass, 4) biliopancreatic diversion, and 5) duodenal switch.

In general, there is a lack of long-term (5-10 years) and very long-term (> 10 years) outcome studies for modern bariatric surgery that would allow us to better define the role of each one of these procedures, especially after the advent of the laparoscopic approach.

In an animal model, diet induced obese animals exhibiting metabolic syndrome underwent Roux-en-Y gastric bypass with highly reproducible surgical outcomes as well as biochemical and energetic homeostatic abnormalities similar to post-RYGB findings in humans. Weight regain occurs in approximately 20% of patients after two to three years after RYGB. It seems that the weight-loss-promoting effects of chronically elevated plasma PYY concentrations dominate the weight-gain-promoting effects of lowered plasma leptin concentrations, with the relative plasma PYY: leptin concentration ratio determining whether weight loss will be sustained or regained.

Several studies have compared different Roux limb lengths in primary bariatric surgery. It seems to be that long limb RYGB (150cm), especially in patients with BMI > 50 kg/m2, confers at least better short-term weight loss without nutritional consequences. Conversely, other investigators have not found any clinically significant difference in weight loss with increasing Roux limb lengths, especially in patients with BMI < 50 kg/m2 23-26. The following are the main investigators that have increased the malabsorptive component of the failed proximal gastric bypass as a revisional strategy:

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

  • Patients who met NIH criteria for recommendation of a bariatric procedure with the combination of the following characteristics:
  • Failed primary proximal gastric bypass with subsequent revision to a malabsortive distal gastric bypass.
  • Failed primary distal malabsorptive gastric bypass with subsequent revision to increase the restrictive component (revisional: gastroplasty, Fobi, or adjustable gastric band)

排除标准

  • Patients with prior major conversions or revisions.
  • 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: throughout follow-up

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

时间窗: throughout follow-up

次要结局

  • Traditional outcome measurements(Variable)
  • Remission or improvement of comorbidities(throughout follow-up)
  • Health-related Quality of Life (HR-QoL)(at last follow-up)
  • Subjective Satisfaction(at the last follow-up)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验

Adding Malabsorption for Failed Gastric Bypass | 临床试验