NCT06157645

Prophylactic Mesh Reinforcement for Stoma Closure

Prophylactic Onlay Mesh Reinforcement vs Anatomical Closure in Stoma Reversal: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

Conditions

• Incisional Hernia
• Surgical Site Infection
• Postoperative Pain
• Hospital Stay, Length of Stay in Hospital From Surgery to Discharge
• Complication

Interventions

Type	Name	Description
DEVICE	Prolene mesh	Application of mesh onlay post stoma closure

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-07-01
• Completion: 2025-09-01
• First posted: 2023-12-06
• Last updated: 2025-12-15

Locations

1 site across 1 country: Egypt