Benefit of Single Port-surgery in Sleeve Gastrectomy (MINIOB)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Surgical Treatment of Obesity

Treatments: Procedure: Sleeve gastrectomy multi trocar; Procedure: Sleeve gastrectomy single port

Study type: Interventional

Funder types: Other

Identifiers

NCT02360176

P130940

Details and patient eligibility

About

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

Full 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.

Enrollment: 332 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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332 participants in 2 patient groups

Sleeve gastrectomy single port

Experimental group

Description:

Sleeve gastrectomy single port

Treatment:

Procedure: Sleeve gastrectomy single port

Sleeve gastrectomy multi trocar

Active Comparator group

Description:

Sleeve gastrectomy multi trocar

Treatment:

Procedure: Sleeve gastrectomy multi trocar