Clinical Trial: Internal Hernias After Laparoscopic Gastric Bypass
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Incidence of Internal Hernias After Laparoscopic Roux-en-Y Gastric Bypass Over the Last Decade: 1997 to 2008
Brief Summary: 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.
Detailed Summary:
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,
Sponsor: University of California, San Francisco
Current Primary Outcome:
- 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 [ Time Frame: throughout follow-up ]
- recurrence of symptomatic mesocolic internal hernia [ Time Frame: throughout follow-up ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of California, San Francisco
Dates:
Date Received: December 26, 2009
Date Started: May 2009
Date Completion:
Last Updated: September 23, 2013
Last Verified: September 2013
