Clinical trial NCT02360176: Benefit of Single Port-surgery in Sleeve Gastrectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Treatment of Obesity
Keywords: single port surgery
bariatric surgery
sleeve gastrectomy
randomise prospective study
complication rate
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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
* 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"

Primary outcomes:
measure: Complication rate
timeFrame: up to 24 months
Secondary outcomes:
measure: Complication rate
timeFrame: up 3, 6, 9, and 12 months
measure: Reduction of excess weight by measuring BMI in kg / m2 pre-and postoperatively
timeFrame: up 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Montsouris Insitut
Study officials:
affiliation: Montsouris Institut
name: Guillaume Pourcher, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: