MINIOB: Benefit of Single Port-surgery in Sleeve Gastrectomy

Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Active, not recruiting ID

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
  • Procedure: Sleeve gastrectomy single port
  • Procedure: Sleeve gastrectomy multi trocar

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

Study Type:
Actual Enrollment :
332 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
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
Actual Study Start Date :
Jan 4, 2017
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2022

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

  1. 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

  1. Complication rate [up 3, 6, 9, and 12 months]

  2. Reduction of excess weight by measuring BMI in kg / m2 pre-and postoperatively [up 3, 6, 12 and 24 months]

Eligibility Criteria


Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Accepts 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"

Contacts and Locations


Site City State Country Postal Code
1 Montsouris Insitut Paris France 75014

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris


  • Principal Investigator: Guillaume Pourcher, MD PhD, Montsouris Institut

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris Identifier:
Other Study ID Numbers:
  • P130940
First Posted:
Feb 10, 2015
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Keywords provided by Assistance Publique - Hôpitaux de Paris

Study Results

No Results Posted as of Sep 16, 2020