Benefit of Single Port-surgery in Sleeve Gastrectomy

Not Applicable

• Conditions: Surgical Treatment of Obesity
• Interventions: Procedure: Sleeve gastrectomy multi trocar; Procedure: Sleeve gastrectomy single port

• Registration Number: NCT02360176
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-10
• Study Start: 2017-01-04
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 332

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"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleeve gastrectomy multi trocar	Sleeve gastrectomy multi trocar	Sleeve gastrectomy multi trocar
Sleeve gastrectomy single port	Sleeve gastrectomy single port	Sleeve gastrectomy single port

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Reduction of excess weight by measuring BMI in kg / m2 pre-and postoperatively	up 3, 6, 12 and 24 months
Complication rate	up 3, 6, 9, and 12 months

Trial Locations

Locations (1)

Montsouris Insitut; 🇫🇷 Paris, France