Prophylactic Onlay Mesh Reinforcement vs Anatomical Closure in Stoma Reversal: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Assiut University
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Incisional (stoma-site) hernia rate
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
In the current work we are aiming to compare between the mesh-reinforced stoma closure and the anatomical closure in terms of the risk of developing surgical site incisional hernia (SSIH),incidence of surgical site infection , post-operative Pain and Hospital stay
Detailed Description
Intestinal stomas are used to divert intestinal content as a treatment option. Faecal flow is diverted from the site of the pathology by bringing the end or a loop of bowel through the anterior abdominal wall; any segments of the colon can be used, as well as the distal part of the ileum. A stoma may be temporary or permanent according to the condition. Temporary stomas are usually followed by elective stoma closure 6-8 weeks after. Though considered a relative safe procedure, studies reported high morbidity rates following stoma closure with different complications. Incisional hernia following stoma closure occurs in up to 30% of patients. Incisional hernia affects quality of life, in regards to pain, physical function, ability to work, and cosmoses. Other serious complications due to bowel obstruction with incarceration or strangulation can occur which may necessitate reoperation. Mesh-reinforced stoma closure shown to decrease the incidence of surgical site incisional hernia (SSIH) with low complications risk. Though there is a debate about its efficacy due to lake of data ,and doubt to use a mesh in contaminated wounds due to fear of wounds complications which may necessitate mesh extraction or longer hospital stay make it hard for many surgeons to use Mesh-reinforced stoma closure. In the current work we are aiming to compare between the mesh-reinforced stoma closure and the anatomical closure in terms of the risk of developing (SSIH),incidence of surgical site infection ,post-operative Pain and Hospital stay
Investigators
Mahmoud Abdelwahed Abdeljaber
Principal investigator
Assiut University
Eligibility Criteria
Inclusion Criteria
- •Patients who are fit for aesthesia.
- •Patients with temporary double barrelled and simple loop ostomy
- •Patients older than 16 years old
- •Exclusion criteria:
- •Patients with end ostomy
- •Infected stomas
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incisional (stoma-site) hernia rate
Time Frame: Up to 12 months postoperatively
Proportion of participants developing an incisional hernia at the stoma site, confirmed by physical examination or imaging (ultrasound/CT).
Secondary Outcomes
- Surgical site infection rate(Within 30 days postoperatively)
- post-operative Pain(Daily for the first 7 postoperative days)
- Length of hospital stay(through study completion, an average of 2 years)
- Postoperative complications(Within 30 days postoperatively)
- Operative time(Intraoperative (from skin incision to skin closure))
- Intraoperative blood loss(through study completion, an average of 2 years)