跳至主要内容
临床试验/NCT01040364
NCT01040364已完成不适用

Incidence of Internal Hernias After Laparoscopic Roux-en-Y Gastric Bypass Over the Last Decade: 1997 to 2008

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2009年5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
220
试验地点
1
主要终点
recurrence of symptomatic mesocolic internal hernia

研究概览

简要总结

The main goal of this study is to describe the trends in the incidence rate of internal hernia presentation after different modifications of the mesenteric closure technique after primary laparoscopic Roux-en-Y gastric bypass (RYGB) surgery from 1997-2009.

详细描述

The main goal of this study is to describe and analyze the trends in the incidence rate of internal hernia presentation after different modifications of the mesenteric closure technique after Primary Laparoscopic RYGB Surgery from 1997 to 2009.

Secondary study aims are to describe the following points 1. Clinical presentation, whether acute (small bowel obstruction), chronic (intermittent abdominal pain), or incidental finding -(asymptomatic); 2. Preoperative image studies. The percentage of patients that underwent preoperative CT/contrast studies as well as the percentage of patients that had positive, undetermined, and normal results; 3. Site of internal herniation including transverse mesocolon, jejunal mesentery, and Peterson's space as well as single vs. multiple internal hernias. This study along with the existing literature will allow us to formulate preliminary clinical recommendations.

This research is in line with the most current provocative new ideas and recent high impact publications. Most literature points towards the antecolic routing of the Roux limb to decrease the incidence rate of internal hernia formation. However, with this study we will demonstrate the statistically and clinically significant decrement of internal hernia formation with the improvement of the closure technique with a retrocolic antegastric routing of the Roux limb.

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 percent, systemic arterial hypertension was resolved in 61.7 percent, dyslipidemia improved in 70 percent, and obstructive sleep apnea-hypopnea syndrome was resolved in 85.7 percent. Furthermore, bariatric surgery significantly increases life expectancy (89 percent) and decreases overall mortality (30 to 40 percent), 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 American Society of Metabolic and Bariatric Surgery "ASMBS" reported that 81 percent of bariatric procedures were approached laparoscopically. 205,000 people, in 2007, had bariatric surgery in the United States from which approximately 80 percentage 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 surgery10. Along with the increasing number of elective primary weight loss procedures, up to 20 percent 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 reoperations for technical or mechanical complications will rise in a parallel manner. RYGB is consistently considered the revisional procedure of choice for failed restrictive procedures.

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

  • patient status post primary laparoscopic standard RYGB surgery who underwent internal hernia reduction and repair with any or the combination of the following:
  • closure of synchronous mesocolic or mesenteric space defects without incarcerated bowel
  • conversion to open (laparotomy)
  • small bowel resection with or without reversal
  • status post primary laparoscopic standard RYGB surgery with incidental finding of internal hernia space defect with or without bowel through the defect

排除标准

  • any other type of re-operative surgery after primary standard RYGB
  • patient age < 18 years
  • missing records and/or unreachable patients with scant information for analysis

结局指标

主要结局

recurrence of symptomatic mesocolic internal hernia

时间窗: throughout follow-up

Closure technique for mesocolic defect: 1- non-closure, 2- running with absorbable material, 3- interrupted with non-absorbable material, and 4- running with non-absorbable

时间窗: throughout follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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