Efficiency of TISSEEL for Sleeve Gastrectomy Complications

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

PHASE3

Total Enrollment

597 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2018-05-15

Brief Summary

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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.

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Detailed Description

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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)

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

Outcome Assessors

Study Groups

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tisseel

tisseel will be applied during the surgery

Group Type EXPERIMENTAL

tisseel

Intervention Type DRUG

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.

no tisseel

no tisseel will be applied during the surgery

Group Type PLACEBO_COMPARATOR

no tisseel

Intervention Type OTHER

the surgeon does not applied tissucol during the surgery

Interventions

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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.

Intervention Type DRUG

no tisseel

the surgeon does not applied tissucol during the surgery

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No