Efficiency of TISSEEL for Sleeve Gastrectomy Complications

Study Overview
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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.

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)

Official Title
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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

Conditions
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Morbid Obesity

Intervention / Treatment
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* Drug: tisseel
* Other: no tisseel


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tisseel<br>tisseel will be applied during the surgery | Drug: tisseel<br>* 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.<br>|
| Placebo Comparator: no tisseel<br>no tisseel will be applied during the surgery | Other: no tisseel<br>* the surgeon does not applied tissucol during the surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of post-operative complications | 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 |  | post operative day 30 | 
| The postoperative hemorrhage's rate |  | 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 overall mortality at one month |  | post-operative day 30 | 
| the specific mortality at one month |  | post-operative day 30 | 
| the rate of postoperative morbidity | the morbidity will be evaluated according to the clavien dindo classification | postoperative day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, surgical management, sleeve gastrectomy