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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elasto compression belt | Experimental | all patients must wear the belt 2 months after laparoscopic digestive surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OBESINOV elasto-compressive belt | Device | It is a customised medical device, using a technique for calculating the compression ratio adapted to each patient according to his morphology |
| Measure | Description | Time Frame |
|---|---|---|
| Presence or not of an eventration | The presence of the eventration is detected by an abdominal CT scan. | During the 24 months following sugery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction: 5 level Likert scale2 | The satisfaction of patient is evaluated by the 5 level Likert scale2 | 2 months after surgery |
| Quality of life of patients: SF-36 quetionnaire | The quality of life of patients is evaluated using SF-36 quetionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Sauret | Contact | 0156616968 | 0033 | isabelle.sauret@imm.fr |
| Mouloud Bellahoues | Contact | 0156616486 | 0033 | mouloud.bellahoues@imm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Guillaume Pourcher, Dr | Institut Mutualiste Montsouris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Mutualiste Montsouris | Recruiting | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23232997 | Background | 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. | |
| 24960483 | Background |
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No plan to share IPD
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D020139 | Gastroschisis |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Feasibility study, single arm, interventional and prospective.
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| 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. | 2 months after surgery |
| 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. |
| 26389785 | Background | 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. |
| 28445797 | Background | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |