Efficiency of TISSEEL for Sleeve Gastrectomy Complications

Centre Hospitalier Universitaire, Amiens

Status and phase: Completed; Phase 3

Conditions: Morbid Obesity

Treatments: Other: no tisseel; Drug: tisseel

Study type: Interventional

Funder types: Other

Identifiers

NCT01613664

PI11-PR-REGIMBEAU-2

Details and patient eligibility

About

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.

Full 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)

Enrollment: 597 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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597 participants in 2 patient groups, including a placebo group

tisseel

Experimental group

Description:

tisseel will be applied during the surgery

Treatment:

Drug: tisseel

no tisseel

Placebo Comparator group

Description:

no tisseel will be applied during the surgery

Treatment:

Other: no tisseel