Trial Comparing Early Complications of Two Techniques in the Laparoscopic Gastric Bypass

This study has been completed.

First Received: February 28, 2008 Last Updated: March 7, 2008 History of Changes

Sponsored by:	Hospital Universitari de Bellvitge
Information provided by:	Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:	NCT00632593

Purpose

The purpose of this study is to define and evaluate the early complications between two different surgical techniques used to perform a laparoscopic gastric bypass

Condition	Intervention
Obesity	Procedure: Laparoscopic Gastric Bypass

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Official Title:	Prospective Randomized Trial Comparing Early Complications of Hand-Sewn Versus Circular Stapled Gastro-Jejunal Anastomosis in Laparoscopic Gastric Bypass

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Hospital Universitari de Bellvitge:

Enrollment:	102
Study Start Date:	March 2005
Study Completion Date:	May 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Circular Stapled: Active Comparator Patients operated performing the gastric pouch of the gastric bypass with a circular staple device	Procedure: Laparoscopic Gastric Bypass
Handsewn anastomosis: Active Comparator Patients operated performing the gastric pouch of the gastric bypass in a handsewn manner	Procedure: Laparoscopic Gastric Bypass

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Body mass Index between 35 with comorbidities and 50 kg/mt2

Exclusion Criteria:

Body mass index <35kg7mt2 and >50kg/mt2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632593

Locations

Spain, Catalonia
University Hospital Of Bellvitge
Barcelona, Catalonia, Spain, 08907

Sponsors and Collaborators

Hospital Universitari de Bellvitge

Investigators

Principal Investigator:

Leonardo J Silvio, MD

University Hospital of Bellvitge

More Information

No publications provided

Responsible Party:	University Hospital of Bellvitge ( Leonardo J Silvio )
Study ID Numbers:	BPGlap1
Study First Received:	February 28, 2008
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00632593 History of Changes
Health Authority:	Spain: Ethics Committee

Keywords provided by Hospital Universitari de Bellvitge:

Early Complications of both techniques
Fistula rate
Dehiscence rate
reoperation rate and cause

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Fistula

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on September 10, 2009