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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014