Prevention of Abdominal Incisional Hernia After Laparoscopic Digestive Surgery in Obese Patients (BMI>30kg/m2) (EVINOV)

September 2, 2020 updated by: Institut Mutualiste Montsouris

EVINOV: Prevention of Abdominal Incisional Hernia After Laparoscopic Digestive Surgery in Obese Patients (BMI>30kg/m2)

The hypothesis of this study is to show that after laparoscopic digestive surgery in obese patients (BMI>30kg/m2), the wearing of an abdominal support belt is an effective treatment for the Incisional Hernia and feasible in terms of compliance, quality of life and patient satisfaction

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted at the Institut Mutualiste Montsouris, it is planned to include 350 patients in 12 months, the duration of participation of each patient is 24 months.

An orthopaedist will see patients in consultation to take their measurements, patients complete a quality of life questionnaire (the SF 36), when they are admitted for surgery.

After surgery, patients begin wearing their belts according to the instructions given by the surgeon during hospitalization:

  • Start wearing the belt as soon as possible.
  • wear it according to its recommendations: all day, every day of the week and for two months.

Patients should record the number of hours they would have worn their belts in the EVINOV logbook each day.

The studu Co will contact patients by phone every two weeks for the 2 months they will be wearing the belt.

At the one-month post-operative consultation, the patient will complete a quality of life questionnaire again (the SF 36).

Two months after surgery, patients receive a final SF 36 questionnaire by mail, with a satisfaction scale to evaluate their overall feeling around the period of wearing the abdominal belt. Patients are asked to return these two documents, as well as the EVINOV logbook.

The latest health data collection is the imaging data from the abdominal CT scan at 24 months, which will show the presence or absence of an incisional hernia.

Study Type

Interventional

Enrollment (Anticipated)

350

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
        • Recruiting
        • Institut Mutualiste Montsouris
        • Contact:
        • Principal Investigator:
          • Guillaume Pourcher, Dr

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be ≥18 years of age.
  • Signed an informed consent form (ICF) indicating that the subject understands the purpose of and procedures required for the study.
  • Having a BMI >30kg/m2.
  • Affiliated to health insurance regimen.
  • Having undergone laparoscopic digestive surgery

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Patient under guardianship or unable to give consent.
  • People particularly protected by French law.
  • Having undergone laparoscopic digestive surgery with ileostomy or ostomy closure.

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elasto compression belt
all patients must wear the belt 2 months after laparoscopic digestive surgery.
Device: OBESINOV elasto-compressive belt
It is a customised medical device, using a technique for calculating the compression ratio adapted to each patient according to his morphology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence or not of an eventration
Time Frame: During the 24 months following sugery
The presence of the eventration is detected by an abdominal CT scan.
During the 24 months following sugery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction: 5 level Likert scale2
Time Frame: 2 months after surgery
The satisfaction of patient is evaluated by the 5 level Likert scale2
2 months after surgery
Quality of life of patients: SF-36 quetionnaire
Time Frame: before surgery, 1 month after surgery and 2 months after surgery.
The quality of life of patients is evaluated using SF-36 quetionnaire.
before surgery, 1 month after surgery and 2 months after surgery.
Compliance with preventive treatment by the abdominal support belt.
Time Frame: 2 months after surgery
Patient compliance collected through a logbook completed daily.
2 months after surgery

Collaborators and Investigators

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

Sponsor

Institut Mutualiste Montsouris

Investigators

  • Study Chair: Guillaume Pourcher, Dr, Institut Mutualiste Montsouris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 26, 2019

Primary Completion (Anticipated)

April 15, 2022

Study Completion (Anticipated)

April 15, 2022

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

September 2, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIG-02-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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