Efficiency of TISSEEL for Sleeve Gastrectomy Complications

Phase 3

Completed

• Conditions: Morbid Obesity
• Interventions: Other: no tisseel; Drug: tisseel

• Registration Number: NCT01613664
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

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 Timeline

• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-07
• Study Start: 2014-02
• Primary Completion: 2018-05-15
• Study Completion: 2018-05-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 597

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no tisseel	no tisseel	no tisseel will be applied during the surgery
tisseel	tisseel	tisseel will be applied during the surgery

Primary Outcome Measures

Name	Time	Method
presence of post-operative complications	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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

North Universitary Hospital; 🇫🇷 Amiens, France

Charles Nicolle Universitary Hospital; 🇫🇷 Rouen, France