Benefit of Single Port-surgery in Sleeve Gastrectomy

Study Overview
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Brief Summary
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Demonstrate non-inferiority of the single port for sleeve gastrectomy compared to the reference method in terms of complications using a score of morbidity and mortality at 6 and 24 months: Rate of fistula, intra and extra abdominal abcess, hemorrhage, gastric stenosis, splenic lesions, hernia, residual gastric pouch and mortality

Detailed Description
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The single port surgery is the natural evolution of laparoscopy. To date only few studies have evaluated the feasibility of this technique in sleeve gastrectomy. The investigators want to demonstrate the non-inferiority in terms of morbidity-mortality of use single trocar in sleeve gastrectomy compared the multiport technique. Moreover it should highlight the non-inferiority in terms of anatomical quality, reduction of excess weight lost, reduction of comorbidities, decrease post operative pain, improved quality of life and evaluate medico-economic impact of these technique to validating this new surgical approach for bariatric surgery. The study will be multicentric with 6 university center (Montpellier, Amiens, Lille, Creteil, Poissy and Montsouris Institut). 388 patients will be included in the tow group of the prospective randomise study.

Official Title
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Evaluation of Minimally Invasive Bariatric Surgery Using a Single Laparoscopic Trocar (Single Incision of 2.5 to 3 cm) Versus 4 to 7 Trocars in Sleeve Gastrectomy

Conditions
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Surgical Treatment of Obesity

Intervention / Treatment
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* Procedure: Sleeve gastrectomy single port
* Procedure: Sleeve gastrectomy multi trocar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI> 35 kg/m2 with comorbidity (s) or> 40 kg/m2 Patients aged 18 to 65 years Discussion and decision sleeve gastrectomy multidisciplinary meeting Free, informed and written consent Affiliation to a social security or other assurance Exclusion Criteria - Anesthetics Exclusion Criteria: Uncontrolled severe infection Liver disease other than obesity pathology Pregnancy (positive hCG) Large hiatal hernia Esophagitis uncontrolled History of gastric bypass and gastric surgery other than gastric banding Saving Justice guardianship Participation in another ongoing study Cognitive or severe mental illness Severe and non-stabilized eating disorders Addiction to alcohol and psychoactive substances

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleeve gastrectomy single port<br>Sleeve gastrectomy single port | Procedure: Sleeve gastrectomy single port<br>* Bariatric surgery: one incision of 2.5 to 3 cm<br>|
| Active Comparator: Sleeve gastrectomy multi trocar<br>Sleeve gastrectomy multi trocar | Procedure: Sleeve gastrectomy multi trocar<br>* Bariatric surgery: 4 to 7 incisions of 1 to 2 cm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | The principal criteria of analysis will be a score of morbidity and mortality at 24 months including: rate of fistula and intra-abdominal abscesses, the bleeding rate, the rate of gastric stenosis, rate splenic lesions, residual pouch or parietal damage (abscesses, incisional hernia, hematoma, delayed wound healing), and death | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate |  | up 3, 6, 9, and 12 months | 
| Reduction of excess weight by measuring BMI in kg / m2 pre-and postoperatively |  | up 3, 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single port surgery, bariatric surgery, sleeve gastrectomy, randomise prospective study, complication rate