NCT04537546

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Institut Mutualiste Montsouris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-06-26
• Primary completion: 2022-04-15
• Completion: 2022-04-15
• First posted: 2020-09-03
• Last updated: 2020-09-03

Locations

1 site across 1 country: France