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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OBESINOV elasto-compressive belt
Sponsored by
Institut Mutualiste Montsouris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Laparoscopy, Eventration, Abdominal support belt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institut Mutualiste MontsourisRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elasto compression belt

Arm Description

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

Outcomes

Primary Outcome Measures

Presence or not of an eventration
The presence of the eventration is detected by an abdominal CT scan.

Secondary Outcome Measures

Patient satisfaction: 5 level Likert scale2
The satisfaction of patient is evaluated by the 5 level Likert scale2
Quality of life of patients: SF-36 quetionnaire
The quality of life of patients is evaluated using SF-36 quetionnaire.
Compliance with preventive treatment by the abdominal support belt.
Patient compliance collected through a logbook completed daily.

Full Information

First Posted
August 28, 2020
Last Updated
September 2, 2020
Sponsor
Institut Mutualiste Montsouris
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1. Study Identification

Unique Protocol Identification Number
NCT04537546
Brief Title
Prevention of Abdominal Incisional Hernia After Laparoscopic Digestive Surgery in Obese Patients (BMI>30kg/m2)
Acronym
EVINOV
Official Title
EVINOV: Prevention of Abdominal Incisional Hernia After Laparoscopic Digestive Surgery in Obese Patients (BMI>30kg/m2)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
April 15, 2022 (Anticipated)
Study Completion Date
April 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Mutualiste Montsouris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Laparoscopy, Eventration, Abdominal support belt

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study, single arm, interventional and prospective.
Masking
None (Open Label)
Allocation
N/A
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Elasto compression belt
Arm Type
Experimental
Arm Description
all patients must wear the belt 2 months after laparoscopic digestive surgery.
Intervention Type
Device
Intervention Name(s)
OBESINOV elasto-compressive belt
Intervention Description
It is a customised medical device, using a technique for calculating the compression ratio adapted to each patient according to his morphology
Primary Outcome Measure Information:
Title
Presence or not of an eventration
Description
The presence of the eventration is detected by an abdominal CT scan.
Time Frame
During the 24 months following sugery
Secondary Outcome Measure Information:
Title
Patient satisfaction: 5 level Likert scale2
Description
The satisfaction of patient is evaluated by the 5 level Likert scale2
Time Frame
2 months after surgery
Title
Quality of life of patients: SF-36 quetionnaire
Description
The quality of life of patients is evaluated using SF-36 quetionnaire.
Time Frame
before surgery, 1 month after surgery and 2 months after surgery.
Title
Compliance with preventive treatment by the abdominal support belt.
Description
Patient compliance collected through a logbook completed daily.
Time Frame
2 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Sauret
Phone
0156616968
Ext
0033
Email
isabelle.sauret@imm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mouloud Bellahoues
Phone
0156616486
Ext
0033
Email
mouloud.bellahoues@imm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Pourcher, Dr
Organizational Affiliation
Institut Mutualiste Montsouris
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Pourcher, Dr
Phone
0156616309
Ext
0033
Email
guillaume.pourcher@imm.fr
First Name & Middle Initial & Last Name & Degree
Guillaume Pourcher, Dr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD
Citations:
PubMed Identifier
23232997
Citation
Lee DY, Rehmani SS, Guend H, Park K, Ross RE, Alkhalifa M, McGinty JJ, Teixeira JA. The incidence of trocar-site hernia in minimally invasive bariatric surgery: a comparison of multi versus single-port laparoscopy. Surg Endosc. 2013 Apr;27(4):1287-91. doi: 10.1007/s00464-012-2597-5. Epub 2012 Dec 12.
Results Reference
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PubMed Identifier
24960483
Citation
Agaba EA, Rainville H, Ikedilo O, Vemulapali P. Incidence of port-site incisional hernia after single-incision laparoscopic surgery. JSLS. 2014 Apr-Jun;18(2):204-10. doi: 10.4293/108680813X13693422518317.
Results Reference
background
PubMed Identifier
26389785
Citation
Bosanquet DC, Ansell J, Abdelrahman T, Cornish J, Harries R, Stimpson A, Davies L, Glasbey JC, Frewer KA, Frewer NC, Russell D, Russell I, Torkington J. Systematic Review and Meta-Regression of Factors Affecting Midline Incisional Hernia Rates: Analysis of 14,618 Patients. PLoS One. 2015 Sep 21;10(9):e0138745. doi: 10.1371/journal.pone.0138745. eCollection 2015.
Results Reference
background
PubMed Identifier
28445797
Citation
Weissler JM, Lanni MA, Hsu JY, Tecce MG, Carney MJ, Kelz RR, Fox JP, Fischer JP. Development of a Clinically Actionable Incisional Hernia Risk Model after Colectomy Using the Healthcare Cost and Utilization Project. J Am Coll Surg. 2017 Aug;225(2):274-284.e1. doi: 10.1016/j.jamcollsurg.2017.04.007. Epub 2017 Apr 23.
Results Reference
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Prevention of Abdominal Incisional Hernia After Laparoscopic Digestive Surgery in Obese Patients (BMI>30kg/m2)

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