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

Not Applicable

• Conditions: Obesity
• Interventions: Device: OBESINOV elasto-compressive belt

• Registration Number: NCT04537546
• Lead Sponsor: Institut Mutualiste Montsouris

Brief Summary

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

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 Timeline

• Study Start: 2019-06-26
• Status Verified: 2020-08
• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-09-02
• Last Update Submitted: 2020-09-02
• Study First Posted: 2020-09-03
• Last Update Posted: 2020-09-03
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elasto compression belt	OBESINOV elasto-compressive belt	all patients must wear the belt 2 months after laparoscopic digestive surgery.

Primary Outcome Measures

Name	Time	Method
Presence or not of an eventration	During the 24 months following sugery	The presence of the eventration is detected by an abdominal CT scan.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Mutualiste Montsouris; 🇫🇷 Paris, France