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

September 14, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

332

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Montsouris Insitut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: Sleeve gastrectomy multi trocar
Bariatric surgery: 4 to 7 incisions of 1 to 2 cm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: 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
up to 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2017

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

February 9, 2015

First Posted (Estimate)

February 10, 2015

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P130940

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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