Efficiency of TISSEEL for Sleeve Gastrectomy Complications (TISSEEL)

July 13, 2020 updated by: Centre Hospitalier Universitaire, Amiens

Randomized Prospective Clinical Study Evaluating the Usefulness of Fibrin Glue (TISSEEL® KIT) to Prevent Gastric Fistula, Intra Abdominal Haemorrhage and Intra Abdominal Loco Regional Collections After Laparoscopic Sleeve Gastrectomy

Laparoscopic Sleeve Gastrectomy has emerged over the last 20 years as a treatment of choice in the surgical management of patients with morbid obesity. However, this restrictive procedure is accompanied by outcomes such as gastric fistula (5%), postoperative hemorrhage (1%) and intra-abdominal loco regional collections (1%). At present, there is no sufficiently reliable technique to prevent these complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The hypothesis is the following : the use of fibrin glue (Tissucol ®) during Laparoscopic Sleeve Gastrectomy would reduce the incidence of complications (gastric fistula, intra-abdominal hemorrhage and intra-abdominal locoregional collection).

The aim is to investigate whether the use of fibrin glue (Tissucol®) during Laparoscopic Sleeve Gastrectomy reduces the incidence of postoperative complications (gastric fistula, intra-abdominal hemorrhage and intra-abdominal locoregional collection)

Study Type

Interventional

Enrollment (Actual)

597

Phase

  • Phase 3

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

  • France
      • Amiens, France, 80054
        • North Universitary Hospital
      • Rouen, France, 76031
        • Charles Nicolle Universitary Hospital

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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obesity requiring bariatric surgery (Laparoscopic Sleeve Gastrectomy) according to the Haute Autorité de Santé
  • Patients younger than 60 years old
  • BMI ≤ 60 kg/m2
  • Surgery accepted by an Obesity-related specific committee
  • Patient with social protection

Exclusion Criteria:

  • Previous bariatric or gastric surgery
  • BMI > 60 kg/m2
  • Under 18 years old
  • Allergy to Tissucol®
  • peroperative fistula
  • Consent not signed
  • Incapable of giving his opinion
  • Pregnancy or breast-feeding
  • Contraindication to surgery
  • ASA classification IV

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: tisseel
tisseel will be applied during the surgery
Drug: tisseel
The product will be given as a 2 mL bottle per patient, which will be spread along the staple line. If necessary, a second bottle of 2 mL is used. The precautions for use are described in the user manual.
PLACEBO_COMPARATOR: no tisseel
no tisseel will be applied during the surgery
Other: no tisseel
the surgeon does not applied tissucol during the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of post-operative complications
Time Frame: post operative day 30

The primary endpoint corresponds to the presence of complications after laparoscopic sleeve gastrectomy during the follow up period. A complication is considered as "present" if at least one of the following three items is present:

  • Gastric fistula
  • Postoperative hemorrhage
  • intra-abdominal locoregional collection
post operative day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The gastric fistula's rate
Time Frame: post operative day 30
post operative day 30
The postoperative hemorrhage's rate
Time Frame: post-operative day 30
post-operative day 30
The intra-abdominal locoregional collection's rate
Time Frame: post-operative day 30
post-operative day 30
the length of stay
Time Frame: post-operative day 30
post-operative day 30
the rate of readmission
Time Frame: post-operative day 30
post-operative day 30
the rate of reintervention
Time Frame: post-operative day 30
post-operative day 30
the overall mortality at one month
Time Frame: post-operative day 30
post-operative day 30
the specific mortality at one month
Time Frame: post-operative day 30
post-operative day 30
the rate of postoperative morbidity
Time Frame: postoperative day 30
the morbidity will be evaluated according to the clavien dindo classification
postoperative day 30

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: michel scotte, MD PhD, CHU Rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2014

Primary Completion (ACTUAL)

May 15, 2018

Study Completion (ACTUAL)

May 15, 2018

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (ESTIMATE)

June 7, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI11-PR-REGIMBEAU-2

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 tisseel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe