Reducing the Incidence of Incisional Hernia After Stoma Closure Using a PROphylactic MESH: a Single-blinded Randomized Controlled Trial (PROMESH TRIAL).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Geneva
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Incidence of incisional hernia at site of stoma at one year after closure
Study Overview
Brief Summary
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.
Detailed Description
Background:
Recent pooled evidence indicates that the incidence of incisional hernia after stoma closure is of 7.4%, but this finding is limited by an important heterogeneity (reported incidences ranging from 0 to 48%). The pooled incidence of incisional hernia ranges from 4 to 10% according to the type of stoma, with the highest incidence reported after colostomy closure (10%). These incisional hernias at site of stoma generate patient discomfort, alteration of quality of life, complications such as bowel occlusion and increased costs for healthcare systems.
Several retrospective studies have investigated the impact of a prophylactic mesh during stoma closure on the incidence of incisional hernia. For instance, Liu et al. compared 47 patients who benefited from ileostomy closure with a synthetic non-resorbable mesh with 36 patients who underwent the same surgery without mesh, and found that incidences of incisional hernia (with a median follow-up of 18 months) were of 6.4% and 36.1%, respectively 3. Similarly, a retrospective case-control study compared 30 patients who had ileostomy closure with prophylactic biological mesh with 30 matched patients without mesh. At one year, the incidence of incisional hernia diagnosed with CTscan was of 3.3% in patients with mesh versus 40% in patients without mesh 4. A multicenter randomized controlled trial (RCT) is currently underway to evaluate whether an intra-abdominal mesh allows to prevent the one year incidence of CTscan-proven incisional hernia in patients undergoing ileostomy and colostomy closures 5. A preliminary feasibility study demonstrated the safety of the procedure 6. However, no specific techniques for mesh fixation and position are documented in the RCT protocol, which might introduce confusion factors in the final analysis. Further, applying an intra-abdominal mesh might potentially result in long-term complications due to bowel adhesion to the abdominal wall.
Therefore, we have planned to undertake a RCT aiming at determining whether a prophylactic non-resorbable mesh in the sublay position allows or not reducing the incidence of incisional hernia after ileostomy or colostomy closure.
Methods/Design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Masking Description
Patients will be blinded for the study group.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Intervention (mesh)
Insertion of a non-resorbable mesh in the subway position.
Intervention: Stoma closure with non-resorbable mesh (ULTRAPRO Advanced Mesh, Ethicon, Johnson & Johnson) in the sublay position (Device)
Control (no mesh)
No insertion of mesh.
Intervention: Stoma closure without mesh (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Incidence of surgical site infection (SSI) at site of stoma closure(At seven days and 31 days after stoma closure)
Investigators
Jeremy Meyer
Consultant surgeon
University Hospital, Geneva