Reducing the Incidence of Incisional Hernia After Stoma Closure Using a Prophylactic Mesh (PROMESH)
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ClinicalTrials.gov Identifier: NCT04510558 |
Recruitment Status :
Recruiting
First Posted : August 12, 2020
Last Update Posted : September 13, 2023
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Background:
Preliminary studies have shown that application of a prophylactic mesh during stoma closure reduces the incidence of incisional hernia at site of stoma closure.
Methods/Design:
The study will be a randomized controlled single-blinded monocentric study determining the 1-year incidence of incisional hernia in cancer patients undergoing ileostomy or colostomy closure with or without prophylactic non-absorbable mesh applied in the sublay position.
Discussion:
Prevention of incisional hernia at site of stoma closure will lead to an improvement in patients' quality of life and generating savings for healthcare systems. To date, no randomized controlled trial assessing the effect of prophylactic mesh applied during stoma closure on the prevention of incisional hernia has been published. With the present randomized controlled trial, we expect to demonstrate that the application of a prophylactic mesh reduces the one-year incidence of incisional hernia at site of stoma closure.
Condition or disease | Intervention/treatment | Phase |
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Incisional Hernia | Device: Stoma closure with non-resorbable mesh (ULTRAPRO Advanced Mesh, Ethicon, Johnson & Johnson) in the sublay position Procedure: Stoma closure without mesh | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Patients will be recruited during the preoperative consultation. Patients will be given written information related to the study and will sign an informed consent form. Investigators will be contacted and perform randomization using the RedCap (Research Electronic Data Capture) software system on a 1:1 allocation ratio between study groups. The surgery planning form will be forwarded to the investigators, which will indicate if a mesh should be added or not to the stoma closure procedure. |
Masking: | Single (Participant) |
Masking Description: | Patients will be blinded for the study group. |
Primary Purpose: | Prevention |
Official Title: | Reducing the Incidence of Incisional Hernia After Stoma Closure Using a PROphylactic MESH: a Single-blinded Randomized Controlled Trial (PROMESH TRIAL). |
Actual Study Start Date : | May 1, 2021 |
Estimated Primary Completion Date : | May 2024 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
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Experimental: Intervention (mesh)
Insertion of a non-resorbable mesh in the subway position.
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Device: Stoma closure with non-resorbable mesh (ULTRAPRO Advanced Mesh, Ethicon, Johnson & Johnson) in the sublay position
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Sham Comparator: Control (no mesh)
No insertion of mesh.
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Procedure: Stoma closure without mesh
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- Incidence of incisional hernia at site of stoma at one year after closure [ Time Frame: At one year after stoma closure ]The presence or not of an incisional hernia will be assessed clinically by a specialist in general surgery and radiologically by computed tomography realized in the setting of cancer followup. The investigator performing the 1-year follow-up and the radiologist interpreting the CTscan will be blinded for the study group. Patients diagnosed with incisional hernia and/or reoperated for a complication related to stoma closure and/or mesh will be considered as treatment failure.
- Incidence of surgical site infection (SSI) at site of stoma closure [ Time Frame: At seven days and 31 days after stoma closure ]The presence or not of surgical site infection (SSI) at site of stoma closure, evaluated at 7 and at 31 days after stoma closure according to the Center for Disease Control definition. Specialized nurses will record pictures of the stoma site for blinded evaluation by an investigator. In case of occurrence, SSI will be treated according to institutional guidelines.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Adult patient
- Ileostomy or colostomy performed during surgery for digestive cancer
- Planned elective closure of ileostomy or colostomy
- Informed written consent
Exclusion Criteria:
- Allergy to the mesh
- Patients under corticosteroids or other immunosuppressive treatment
- Inability/refusal to follow the procedures of the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510558
Contact: Jeremy Meyer, MD, MD-PhD | +41795533182 | jeremy.meyer@unige.ch | |
Contact: Vaihere Delaune, MD-PhD | vaihere.delaune@hcuge.ch |
Switzerland | |
University Hospitals of Geneva | Recruiting |
Geneva, Switzerland, 1205 | |
Contact: Nicolas Buchs, MD, PD nicolas.c.buchs@hcuge.ch | |
Contact: Vaihere Delaune, MD-PhD vaihere.delaune@hcuge.ch |
Study Director: | Nicolas Buchs, MD, PD | University Hospitals of Geneva |
Responsible Party: | Jeremy Meyer, Consultant surgeon, University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT04510558 |
Other Study ID Numbers: |
PROMESH TRIAL |
First Posted: | August 12, 2020 Key Record Dates |
Last Update Posted: | September 13, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
mesh ileostomy colostomy stoma closure |
Hernia Incisional Hernia Pathological Conditions, Anatomical Postoperative Complications Pathologic Processes |