Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial

October 21, 2011 updated by: Paolo Gentileschi, University of Rome Tor Vergata
The main drawback of laparoscopic sleeve gastrectomy (LSG) is the severity of post-operative complications. Staple line reinforcement (SLR) is strongly advocated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was to prospectively and randomly compare three different techniques of SLR during LSG: oversewing (group A), buttressed transection with a polyglycolide acid and trimethylene carbonate (group B) and staple-line roofing with a gelatin fibrin matrix (group C).

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

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

28 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Morbidly obese patients waiting for sleeve gastrectomy

Exclusion Criteria:

  • BMI<35 Kg/m2,
  • Important comorbidities

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bleeding, leak, operative time
Procedure: Bariatric surgery
Staple line reinforcement during sleeve gastrectomy
Other Names:
  • bariatric surgical procedure
  • gastric resection
  • steaple line reinforcement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of staple line reinforcement during laparoscopic sleeve gastrectomy by measuring the number of adverse effects, i.e. bleeding and leaks.
Time Frame: six months
a comparison between three techniques of staple line reinforcement. The number of adverse events will be registered and analyzed
six months

Collaborators and Investigators

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

Sponsor

University of Rome Tor Vergata

Investigators

  • Study Director: Paolo Gentileschi, MD, University of Tor Vergata, Rome, Italy

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

April 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 4, 2011

First Submitted That Met QC Criteria

October 21, 2011

First Posted (Estimate)

October 25, 2011

Study Record Updates

Last Update Posted (Estimate)

October 25, 2011

Last Update Submitted That Met QC Criteria

October 21, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • SEND-11-0905

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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 Complication of Surgical Procedure

Clinical Trials on Bariatric surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe