Two or Five cm From Pylorus During Laparoscopic Sleeve Gastrectomy

May 2, 2013 updated by: Ahmed Abdel-Raouf El-Geidie, Mansoura University

Comparative Study Between Two and Five cm Resection During Laparoscopic Sleeve Gastrectomy

The investigators compare two techniques for laparoscopic sleeve gastrectomy. in the first one the distal margin of stapling is 2 cm from the pylorus and in the second it is 6 cm away from the pylorus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

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

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Gastroenterology Surgical Center

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • morbid obese patients

Exclusion Criteria:

  • contraindication to laparoscopy

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2 cm from pylorus
at laparoscopic sleeve gastrectomy the distal point of gastric division is 2 cm from the pylorus.
Procedure: laparoscopic sleeve gastrectomy
Active Comparator: 6 cm from pylorus
at laparoscopic sleeve gastrectomy the distal point of gastric division is 6 cm from the pylorus
Procedure: laparoscopic sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of excess weight loss
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
complications
Time Frame: 2 years
2 years

Other Outcome Measures

Outcome Measure
Time Frame
improvement of comorbidities
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Mansoura University

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

June 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

February 10, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Estimate)

May 6, 2013

Last Update Submitted That Met QC Criteria

May 2, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013 (Other Grant/Funding Number: Food Innovation Center)

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.

Clinical Trials on Morbid Obesity

Clinical Trials on laparoscopic sleeve gastrectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe