Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy

NCT ID: NCT00793728

Last Updated: 2015-08-20

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2015-08-31

Brief Summary

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This study compares if there is any difference doing antrectomy while performing a sleeve gastrectomy for treating morbid obesity. The investigators compare the differences between leaving or not leaving the antrum in terms of food tolerance, weight lost and quality of life.

Detailed Description

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Conditions

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Morbid 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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Antrectomy

Group Type ACTIVE_COMPARATOR

Sleeve gastrectomy

Intervention Type PROCEDURE

Perform a gastrectomy guided by a 38F catheter and parallel to the small curvature of the stomach

Without antrectomy

Group Type ACTIVE_COMPARATOR

Sleeve gastrectomy

Intervention Type PROCEDURE

Perform a gastrectomy guided by a 38F catheter and parallel to the small curvature of the stomach

Interventions

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Sleeve gastrectomy

Perform a gastrectomy guided by a 38F catheter and parallel to the small curvature of the stomach

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI\>40 kg/m2
* Age \>18 years old
* Eligible for laparoscopic surgery

Exclusion Criteria

* Prior bariatric surgery
* Sleeve gastrectomy as a part of a duodenal switch
* Second time surgery before 18 months
* Other procedures done during the surgery
* Conversion to laparotomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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Amador Garci-a Ruiz de Gordejuela

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amador Garcia Ruiz de Gordejuela, Consultant

Role: PRINCIPAL_INVESTIGATOR

Consultant of Surgery

Jordi Pujol Gebelli, Consultant

Role: PRINCIPAL_INVESTIGATOR

Consultant of Surgery

Carles Masdevall Noguera, Consultant

Role: PRINCIPAL_INVESTIGATOR

Consultant of Surgery

Locations

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Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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PR131/08

Identifier Type: -

Identifier Source: org_study_id

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