Laparoscopic Revisional Gastric Bypass Surgery for Failed and/or Complicated Open Vertical Banded Gastroplasty: Our Experience With 70 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 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 intermediate term outcomes after laparoscopic revision Roux-en-Y gastric bypass (RYGB) surgery for failed and/or complicated Vertical Banded Gastroplasty (VBG). 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. 3) Subjective Satisfaction and Health-Related Quality of Life "HR-QoL" are measured by a standardized, non-validated satisfaction questionnaire and by a validated, disease-specific worldwide used HR-QoL questionnaire. 4) Morbidity & Mortality include nutritional status and metabolic complications.
Consequently, secondary objectives of this study are the following. 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 assessed at each postoperative year after the surgery under study. 2) To evaluate the metabolic and nutritional status by measurements of particular clinical and biochemical parameters.
详细描述
There is no real standardization for any of the previously stated "modern standard bariatric procedures" endorse by the ASMBS; thus, outcomes vary widely with each one of them. For purposes of this study, the term Vertical Banded Gastroplasty (VBG) is used to encompass several types of vertical gastroplasties with a reinforced stoma such as nondivided vertical banded gastroplasty, nondivided vertical ringed gastroplasty, transected or divided vertical ringed or banded gastroplasties among others. VBG, in various forms, was used extensively for more than 2 decades after its original description by Mason in 198217. Designed to avoid the long-term nutritional implications and complexity of gastric bypass, VBG evolved and permitted us to infer some mechanism of failure and modify other bariatric procedures. Regardless of a laparoscopic approach, VBG is no longer a viable option for the treatment of morbid obesity because of less overall weight loss, high failure and late complication rates.
The following are the main investigators that have addressed diverse revisional strategies including restoration or conversion of VBG into a modern bariatric procedure, either by open or laparoscopic approach, because of failure and/or technical complications:
I. Open approach. Most of the scientific literature available on redo bariatric surgery is based on open surgery series. There is no consensus on what type of revisional procedure is the best; however, there are several options available.
A) Restoration or re-VBG is no longer a viable option.
- In a study of 122 gastroplasties, Sugerman et al reported that four out of ten re-VBG patients required a third revision.
- With a Kaplan-Meyer analysis, Van Gemert et al found that re-VBG carry a secondary revisional rate of 68% over a 5-year period vs. a 0% rate after conversion to RYGB.
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
- 否
入选标准
- •Patients status post failed and/or complicated VBG undergoing laparoscopic revisional RYGB
排除标准
- •Patients with prior major conversion, revision, and/or esophago-gastric surgery
- •Conversion performed by open approach
- •Conversion performed somewhere else with follow-up by our program
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 8 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 8 years
Remission or improvement of symptoms
时间窗: at 6 months, 1 year and annually thereafter for up to 8 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)
- Remission or improvement of comorbidities(at 6 months, 1 year, and annually thereafter for up to 8 years)
- 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.)