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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-26

Study Completion Date

2022-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endoscopic Gastric Plication for Weight Loss in Morbidly Obese Patients Prior to Incisional Hernia Repair

NCT02078934

Morbid Obesity Weight Loss Complex Incisional Hernias

WITHDRAWN NA

Randomized Controlled Prospective Multicenter Study Primary Onlay- Mesh After Elective Median Laparotomy in Patients With BMI ≥ 27

NCT01507870

Incisional Hernia Obesity

TERMINATED NA

Trocar Site Incisional Hernia Prevention

NCT04699201

Incisional Hernia

RECRUITING NA

Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI

NCT03105895

Incisional Hernia

UNKNOWN

Flexible Composite Next Generation Tissue Separating Mesh in Laparoscopic Incisional/Ventral Hernia Repair

NCT01162564

Incisional Hernia Ventral Hernia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Feasibility study, single arm, interventional and prospective.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Elasto compression belt

all patients must wear the belt 2 months after laparoscopic digestive surgery.

Group Type EXPERIMENTAL

OBESINOV elasto-compressive belt

Intervention Type DEVICE

It is a customised medical device, using a technique for calculating the compression ratio adapted to each patient according to his morphology

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No