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

Obesity Clinical Trial

— EVINOV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04537546
• Other study ID #: DIG-02-2018
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2019
• Est. completion date: April 15, 2022

Study information

• Verified date: August 2020
• Source: Institut Mutualiste Montsouris
• Contact: Isabelle Sauret
• Phone: 0156616968
• Email: isabelle.sauret[@]imm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Incisional Hernia
• Obesity

Intervention

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

Locations

Country	Name	City	State
France	Institut Mutualiste Montsouris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or not of an eventration	The presence of the eventration is detected by an abdominal CT scan.	During the 24 months following sugery
Secondary	Patient satisfaction: 5 level Likert scale2	The satisfaction of patient is evaluated by the 5 level Likert scale2	2 months after surgery
Secondary	Quality of life of patients: SF-36 quetionnaire	The quality of life of patients is evaluated using SF-36 quetionnaire.	before surgery, 1 month after surgery and 2 months after surgery.
Secondary	Compliance with preventive treatment by the abdominal support belt.	Patient compliance collected through a logbook completed daily.	2 months after surgery