Long or Very Long-Limb Gastric Bypass in Superobese

Obesity Clinical Trial

Official title: Long or Very Long-Limb Gastric Bypass in Superobese

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT00868543
• Study type: Interventional
• Source: Kaunas University of Medicine
• Contact: Nerijus Kaselis
• Phone: +37069943431
• Email: nkaselis@gmail.com
• Status: Recruiting
• Phase: Phase 3
• Start date: July 2008
• Completion date: December 2015