MINIOB: Benefit of Single Port-surgery in Sleeve Gastrectomy
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sleeve gastrectomy single port Sleeve gastrectomy single port |
Procedure: Sleeve gastrectomy single port
Bariatric surgery: one incision of 2.5 to 3 cm
|
| Active Comparator: Sleeve gastrectomy multi trocar Sleeve gastrectomy multi trocar |
Procedure: Sleeve gastrectomy multi trocar
Bariatric surgery: 4 to 7 incisions of 1 to 2 cm
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
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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)
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Large hiatal hernia
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Esophagitis uncontrolled
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History of gastric bypass and gastric surgery other than gastric banding
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Saving Justice guardianship
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Participation in another ongoing study
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Cognitive or severe mental illness
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Severe and non-stabilized eating disorders
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Addiction to alcohol and psychoactive substances"
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montsouris Insitut | Paris | France | 75014 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Guillaume Pourcher, MD PhD, Montsouris Institut
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P130940