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

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ClinicalTrials.gov Identifier: NCT00632593
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : March 10, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Obesity Procedure: Laparoscopic Gastric Bypass

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing Early Complications of Hand-Sewn Versus Circular Stapled Gastro-Jejunal Anastomosis in Laparoscopic Gastric Bypass
Study Start Date : March 2005
Primary Completion Date : January 2007
Study Completion Date : May 2007
Arms and Interventions

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


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Leonardo J Silvio, University Hospital of Bellvitge
ClinicalTrials.gov Identifier: NCT00632593     History of Changes
Other Study ID Numbers: BPGlap1
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: March 10, 2008
Last Verified: February 2008

Keywords provided by Hospital Universitari de Bellvitge:
Early Complications of both techniques
Fistula rate
Dehiscence rate
reoperation rate and cause