ObesityEVINOVNCT04537546
Prevention of Abdominal Incisional Hernia After Laparoscopic Digestive Surgery in Obese Patients (BMI>30kg/m2)
A study testing OBESINOV elasto-compressive belt in people with Obesity, run by Institut Mutualiste Montsouris at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- OBESINOV elasto-compressive belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2019to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Mutualiste Montsouris
Paris, 75014
Guillaume Pourcher, Dr, 0156616309 ext. 0033, guillaume.pourcher@imm.fr
Guillaume Pourcher, Dr
About this study
Official title: EVINOV: Prevention of Abdominal Incisional Hernia After Laparoscopic Digestive Surgery in Obese Patients (BMI>30kg/m2)
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
Read the 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.
- Conditions
- Obesity
- Being tested
- OBESINOV elasto-compressive belt
- Keywords
- Laparoscopy, Eventration, Abdominal support belt
- Medical subject headings
- Obesity, Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Elasto compression belt | Experimental | all patients must wear the belt 2 months after laparoscopic digestive surgery. Receives: Device: OBESINOV elasto-compressive belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or not of an eventration
The presence of the eventration is detected by an abdominal CT scan.
Measured: During the 24 months following sugery
Secondary outcomes (3)
Patient satisfaction: 5 level Likert scale2
The satisfaction of patient is evaluated by the 5 level Likert scale2
Measured: 2 months after surgery
Quality of life of patients: SF-36 quetionnaire
The quality of life of patients is evaluated using SF-36 quetionnaire.
Measured: before surgery, 1 month after surgery and 2 months after surgery.
Compliance with preventive treatment by the abdominal support belt.
Patient compliance collected through a logbook completed daily.
Measured: 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start26 Jun 2019
- Primary completion15 Apr 2022 (estimated)
- Study completion15 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study, single arm, interventional and prospective.
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Pourcher, Dr, Study chair, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537546
- Sponsor's protocol ID
- DIG-02-2018
- Acronym
- EVINOV
- Status last verified
- Aug 2020
- First submitted
- 28 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Publications
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.
PubMed 23232997Agaba 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.
PubMed 24960483Bosanquet 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.
PubMed 26389785Weissler 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.
PubMed 28445797
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVINOV: Prevention of Abdominal Incisional Hernia After Laparoscopic Digestive Surgery in Obese Patients (BMI>30kg/m2)
- ClinicalTrials.gov ID
- NCT04537546
- Acronym / sponsor ID
- EVINOV / DIG-02-2018
- Conditions
- Obesity
- Keywords
- Laparoscopy, Eventration, Abdominal support belt
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 15 Apr 2022 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study, single arm, interventional and prospective.
| Arm | Type | Receives |
|---|---|---|
| Elasto compression belt | Experimental | Device: OBESINOV elasto-compressive beltall patients must wear the belt 2 months after laparoscopic digestive surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBESINOV elasto-compressive beltIt is a customised medical device, using a technique for calculating the compression ratio adapted to each patient according to his morphology | Device | Elasto compression belt |
Primary outcome
Presence or not of an eventration
Time frame: During the 24 months following sugery
The presence of the eventration is detected by an abdominal CT scan.
3 secondary outcomes
Patient satisfaction: 5 level Likert scale2
Time frame: 2 months after surgery
Quality of life of patients: SF-36 quetionnaire
Time frame: before surgery, 1 month after surgery and 2 months after surgery.
Compliance with preventive treatment by the abdominal support belt.
Time frame: 2 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Background: PubMed 23232997Lee 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.
- Background: PubMed 24960483Agaba 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.
- Background: PubMed 26389785Bosanquet 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.
- Background: PubMed 28445797Weissler 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.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Pourcher, Dr study chair
Institut Mutualiste Montsouris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OBESINOV elasto-compressive belt in people with Obesity, run by Institut Mutualiste Montsouris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Sauret (0156616968 ext. 0033, isabelle.sauret@imm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or not of an eventration (time frame: During the 24 months following sugery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04537546, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.