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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleeve gastrectomy single port | Experimental | Sleeve gastrectomy single port |
|
| Sleeve gastrectomy multi trocar | Active Comparator | Sleeve gastrectomy multi trocar |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleeve gastrectomy single port | Procedure | Bariatric surgery: one incision of 2.5 to 3 cm |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria - Anesthetics
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume Pourcher, MD PhD | Montsouris Institut | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montsouris Insitut | Paris | 75014 | France |
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| Sleeve gastrectomy multi trocar | Procedure | Bariatric surgery: 4 to 7 incisions of 1 to 2 cm |
|