None listed
Conditions
Brief summary
Temporary ileostomies are formed in patients for multiple reasons. Some reasons include permitting bowel rest and promoting healing in patients with inflammatory bowel diseases as well as in patients who have received bowel resections and anastomoses for malignancies. These temporary ileostomies are often reversed at a later point. The site of the ileostomy closure is at risk of incisional hernia formation. These herniae can cause significant impairment in quality of life and often require re-operation for repairs. The high rate of re-operations can incur significant cost to the health system as well as expose patients to the risks of an operation. This project trials the use of a biodegradable mesh at the site of ileostomy closures in an attempt to reduce the rate of incisional herniae thereby, reducing the chances of operative complications as well as reducing a burden off the healthcare system. This project aims to trial the use of the mesh in a randomized study design (Prospective Randomized Open Blinded End-point study) to see if there is a change in the incidence of incisional herniae. Patients will be recruited at the time of the clinic appointment when they are being consented for the reversal of ileostomy procedure. At the time of the operation, the mesh would be implemented depending on whether the patient is in the interventional group. the patient would be followed up in the clinic and receive imaging to assess for whether incisional herniae have formed.
Interventions
During the reversal of ileostomy procedure, the bowel will be anastamosed and placed back into the abdomen. The next step of the procedure is closure of the abdominal wall. The mesh will be implemented into the abdominal wall during this step. Note that the process of mesh placement and implementation is no different to any other incisional herniae repair. No specific training is required to use this mesh for this indication. All board certified general surgeons are qualified to close the abdome
During the reversal of ileostomy procedure, the bowel will be anastamosed and placed back into the abdomen. The next step of the procedure is closure of the abdominal wall. The mesh will be implemented into the abdominal wall during this step. Note that the process of mesh placement and implementation is no different to any other incisional herniae repair. No specific training is required to use this mesh for this indication. All board certified general surgeons are qualified to close the abdomen and implement mesh in the process. Specifically for this mesh, since the mesh has already been in use for repair of herniae (including incisional herniae) in other settings, the surgeons involved have already been using this mesh. If, for any reason, there are any queries regarding the use of this mesh, a Bard representative is available to answer any questios although this is not likely to occur. The implementation of this mesh may prolong the original reversal of ileostomy procedure by 5-10 minutes (can vary from patient to patient, but unlikely). There will be multiple colorectal surgeons performinig this procedure at the institution. To ensure that the mesh is implemented in a consistent manner, there will be a meeting prior to the initiation of the study with all the colorectal surgeons involved in the study to review the methods of mesh implementation to minimize variation in their practices.
Sponsors
Gold Coast University Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Require an elective closure of an ileostomy or a colostomy. 2. The patient is able and willing to provide written informed consent for the study. 3. The patient is aged 18 years or over
Exclusion criteria
1. They are taking part in another clinical study which is related to the surgical procedure 2. They are allergic to mesh material. 3. They have a history of familial adenomatous polyposis (due to increased risk of desmoid tumours) 4. The surgeon determines that a mesh repair will definitely be required due to large parastomal hernia. 5. They are unable or unwilling to provide written informed consent.
Outcome results
None listed