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

March 7, 2008 updated by: Hospital Universitari de Bellvitge

Prospective Randomized Trial Comparing Early Complications of Hand-Sewn Versus Circular Stapled Gastro-Jejunal Anastomosis in Laparoscopic Gastric Bypass

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08907
        • University Hospital of Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Investigators

  • Principal Investigator: Leonardo J Silvio, MD, Hospital Universitari de Bellvitge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Estimate)

March 10, 2008

Last Update Submitted That Met QC Criteria

March 7, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BPGlap1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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