Efficiency of TISSEEL for Sleeve Gastrectomy Complications

• Status: Completed
• Trial end date: 2018-05-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire, Amiens
• Treatments: Fibrin Tissue Adhesive

Criteria

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