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

NCT ID: NCT00632593

Last Updated: 2008-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Circular Stapled

Patients operated performing the gastric pouch of the gastric bypass with a circular staple device

Group Type ACTIVE_COMPARATOR

Laparoscopic Gastric Bypass

Intervention Type PROCEDURE

Handsewn anastomosis

Patients operated performing the gastric pouch of the gastric bypass in a handsewn manner

Group Type ACTIVE_COMPARATOR

Laparoscopic Gastric Bypass

Intervention Type PROCEDURE

Interventions

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Laparoscopic Gastric Bypass

Intervention Type PROCEDURE

Laparoscopic Gastric Bypass

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Body mass index \<35kg7mt2 and \>50kg/mt2
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari de Bellvitge

OTHER

Sponsor Role lead

Responsible Party

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University Hospital of Bellvitge

Principal Investigators

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Leonardo J Silvio, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge

Locations

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University Hospital Of Bellvitge

Barcelona, Catalonia, Spain

Site Status

Countries

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Spain

Other Identifiers

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BPGlap1

Identifier Type: -

Identifier Source: org_study_id

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