Surgical Treatment of Obesity
Conditions
Keywords
single port surgery, bariatric surgery, sleeve gastrectomy, randomise prospective study, complication rate
Brief summary
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
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.
Interventions
PROCEDURESleeve gastrectomy single port
Bariatric surgery: one incision of 2.5 to 3 cm
PROCEDURESleeve gastrectomy multi trocar
Bariatric surgery: 4 to 7 incisions of 1 to 2 cm
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | up to 24 months | 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 |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed