NCT04537546

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

2.8 years

First QC Date

August 28, 2020

Last Update Submit

September 2, 2020

Conditions

Obesity

Keywords

LaparoscopyEventrationAbdominal support belt

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Patient satisfaction: 5 level Likert scale2

    2 months after surgery

  • Quality of life of patients: SF-36 quetionnaire

    before surgery, 1 month after surgery and 2 months after surgery.

  • Compliance with preventive treatment by the abdominal support belt.

    2 months after surgery

Study Arms (1)

Elasto compression belt

EXPERIMENTAL

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

Device: OBESINOV elasto-compressive belt

Interventions

OBESINOV elasto-compressive beltDEVICE

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

Elasto compression belt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Mutualiste Montsouris

Paris, 75014, France

RECRUITING

Related Publications (4)

  • 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.

    PMID: 23232997BACKGROUND

  • 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.

    PMID: 24960483BACKGROUND

  • 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.

    PMID: 26389785BACKGROUND

  • 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.

    PMID: 28445797BACKGROUND

MeSH Terms

Conditions

ObesityGastroschisis

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, AbdominalHerniaPathological Conditions, Anatomical

Study Officials

  • Guillaume Pourcher, Dr

    Institut Mutualiste Montsouris

    STUDY CHAIR

Central Study Contacts

Isabelle Sauret

CONTACT

0156616968isabelle.sauret@imm.fr

Mouloud Bellahoues

CONTACT

0156616486mouloud.bellahoues@imm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Feasibility study, single arm, interventional and prospective.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 3, 2020

Study Start

June 26, 2019

Primary Completion

April 15, 2022

Study Completion

April 15, 2022

Last Updated

September 3, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

No plan to share IPD

Locations

FR(1)