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

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT00632593
First received: February 28, 2008
Last updated: March 7, 2008
Last verified: February 2008
History of Changes
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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
Active Comparator: Circular Stapled
Patients operated performing the gastric pouch of the gastric bypass with a circular staple device
 Procedure: Laparoscopic Gastric Bypass
Active Comparator: Handsewn anastomosis
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
University Hospital Of Bellvitge
Barcelona, Catalonia, Spain, 08907
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Investigators
Principal Investigator: Leonardo J Silvio, MD Hospital Universitari de Bellvitge
  More Information

No publications provided

Responsible Party: Leonardo J Silvio, University Hospital of Bellvitge
ClinicalTrials.gov Identifier: NCT00632593     History of Changes
Other Study ID Numbers: BPGlap1
Study First Received: February 28, 2008
Last Updated: March 7, 2008
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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 13, 2013