Reinforcement Method in Laparoscopic Sleeve Gastrectomy

February 18, 2017 updated by: M.Timucin Aydin, Fatih Sultan Mehmet Training and Research Hospital

Staple Line Reinforcement Methods in Laparoscopic Sleeve Gastrectomy: Comparison of Burst Pressures and Leaks

Laparoscopic sleeve gastrectomy is a technically simple popular bariatric operation with acceptable results. Leaks can occur in long staple lines; therefore, variable reinforcement methods are used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigator compared non-reinforced stapling with three staple line reinforcement methods (suturing, absorbable buttressing material and fibrin glue) in laparoscopic sleeve gastrectomy.

The resected stomach specimens were treated in the same manner of reinforcement as used in the surgeries of the corresponding patients and then insufflated until a burst occurred. The burst pressures of the resected stomach specimens and postoperative events of the patients were recorded.

Study Type

Observational

Enrollment (Actual)

118

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

118 patients with body mass index >40 kg/m2 underwent sleeve gastrectomy and were enrolled into four groups

Description

Inclusion Criteria:

  • body mass index >40 kg/m2

Exclusion Criteria:

  • disruption of the resected stomach during extraction from the abdomen.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
no reinforcement
Group I: 25 patients; no reinforcement (NoR) Observation : Patients would be followed up for any signs of leaks. If any, treatment would be offered appropriataly but the results of treatment are not affiliated as a part in the study.
Other: observation
fibrin glue
Group II: 26 patients; fibrin glue (FG) Observation : Patients would be followed up for any signs of leaks. If any, treatment would be offered appropriataly but the results of treatment are not affiliated as a part in the study.
Other: observation
suture reinforcement
Group III: 44 patients; suture reinforcement with 2-0 polypropylene suture (S) Observation : Patients would be followed up for any signs of leaks. If any, treatment would be offered appropriataly but the results of treatment are not affiliated as a part in the study.
Other: observation
biological buttressing materaia
Group IV: 14 patients; biological buttressing material Observation : Patients would be followed up for any signs of leaks. If any, treatment would be offered appropriataly but the results of treatment are not affiliated as a part in the study.
Other: observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessing prevalence of leaks among different reinforcement methods
Time Frame: 3 months
observation
3 months

Collaborators and Investigators

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

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

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

March 1, 2014

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

April 1, 2015

First Submitted That Met QC Criteria

February 9, 2017

First Posted (ACTUAL)

February 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 18, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FSMTRH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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