NCT00868543

Long or Very Long-Limb Gastric Bypass in Superobese

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Kaunas University of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to compare the clinical efficacy (weight loss and metabolic changes) of long (150 cm) versus very long (250cm) Roux alimentary limb gastric bypass in superobese (BMI\>50) patients.

Detailed description

The study is a multicentre trial in which superobese (BMI\>50) patients will be randomly assigned (in a 1:1 ratio) for laparoscopic gastric Roux-en-Y gastric bypass with: a) long (150 cm) or b) very long (250cm) alimentary Roux limb. Patients will be included from three hospitals: Kaunas University of Medicine Hospital (Lithuania), Klaipeda District Hospital (Lithuania), Vaasa Central Hospital (Finland) ) where preoperative investigation, the same technique surgical procedures and follow up will be performed acording approved protocol. Approximate duration of subject participation Subjects in the study will participate for approximately 5 years: * Preoperative investigation and surgery 3- 5 days in the hospital; * First follow up visit: 6 months after surgery; * Next follow up visits: 12, 24, 36, 48 months after surgery; * Last follow up visit: 5 years after surgery. * The interim results after 12, 24 and 36 months will be calculated and presented before end of the study.

Conditions

• Obesity

Interventions

Type	Name	Description
PROCEDURE	laparoscopic gastric Roux-en-Y gastric bypass	The fundus is separated by linear cutter. The intestine is opened approximately 75 cm from the ligament of Treitz and approached to the stomach. The gastrojejunostomy is performed in antecolic position The jejunum has to be in an antimesenteric position. After removing the endocutter, the anastomotic incision is closed with a continuous suture. The distance between the gastrojejunostomy and jejunojejunostomy was measured on the antimesenteric border with the bowel on a stretch. The jejunojejunostomy is performed in 150cm distance from gastrojejunostomy. The anastomosis is made by a posterior staple line and an anterior suture line. Preparation of a small window for the endocutter branches into the jejunal mesenterium 2-3 cm proximal to the gastrojejunostomy and above the entero-intestinal anastomosis.
PROCEDURE	laparoscopic gastric Roux-en-Y gastric bypass	The fundus is separated by linear cutter. The intestine is opened approximately 75 cm from the ligament of Treitz and approached to the stomach. The gastrojejunostomy is performed in antecolic position The jejunum has to be in an antimesenteric position. After removing the endocutter, the anastomotic incision is closed with a continuous suture. The distance between the gastrojejunostomy and jejunojejunostomy was measured on the antimesenteric border with the bowel on a stretch. The jejunojejunostomy is performed in 250cm distance from gastrojejunostomy. The anastomosis is made by a posterior staple line and an anterior suture line. Preparation of a small window for the endocutter branches into the jejunal mesenterium 2-3 cm proximal to the gastrojejunostomy and above the entero-intestinal anastomosis.

Timeline

• Start date: 2008-07-01
• Primary completion: 2013-07-01
• Completion: 2015-12-01
• First posted: 2009-03-25
• Last updated: 2009-03-25

Locations

1 site across 1 country: Lithuania