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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Device: OBESINOV elasto-compressive belt


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study, single arm, interventional and prospective.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or not of an eventration | 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 | The satisfaction of patient is evaluated by the 5 level Likert scale2 | 2 months after surgery | 
| Quality of life of patients: SF-36 quetionnaire | 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. | Patient compliance collected through a logbook completed daily. | 2 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Eventration, Abdominal support belt