Long or Very Long-Limb Gastric Bypass in Superobese

15:06 EST 24th November 2014 | BioPortfolio

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.

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

Conditions

Obesity

Intervention

laparoscopic gastric Roux-en-Y gastric bypass, laparoscopic gastric Roux-en-Y gastric bypass

Location

KMUK, surgery department
Kaunas
Lithuania
50009

Status

Recruiting

Source

Kaunas University of Medicine

Results (where available)

View Results

Links

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