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

I

Institut Mutualiste Montsouris

Status

Unknown

Conditions

Obesity

Treatments

Device: OBESINOV elasto-compressive belt

Study type

Interventional

Funder types

Other

Identifiers

NCT04537546
DIG-02-2018

Details and patient eligibility

About

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

Full 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.

Enrollment

350 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

350 participants in 1 patient group

Elasto compression belt
Experimental group
Description:
all patients must wear the belt 2 months after laparoscopic digestive surgery.
Treatment:
Device: OBESINOV elasto-compressive belt

Trial contacts and locations

1

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Central trial contact

Isabelle Sauret; Mouloud Bellahoues

Data sourced from clinicaltrials.gov

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