Prophylactic Mesh Reinforcement for Stoma Closure (OASIS)

Assiut University

Status: Completed

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

Treatments: Device: Prolene mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT06157645

Mesh with stoma closur

Details and patient eligibility

About

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

Full 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

Enrollment: 62 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Group A

No Intervention group

Description:

1. Good preparation of the patient preoperative 2. Performing an opening in the skin surrounding the stoma 3-4 mm from the muco-cutaneous junctions. 3. Separate the bowel loop away from its attachment to the abdomen wall. 4. Cut out a rim of 0.3-0.4 cm of scarred bowel edges exposes healthful tissue. 5. Avoid any spillage or soiling 6. Closing of bowel defect can be made by double layer of 3-0 vicryl interrupted. 7. Once the tissue is of poor quality for simply closing, we expand the incision in the abdomen wall and resect a section. An end-to-end anastomosis is created using the conventional 2-layers suture method. 8. Reduction of the bowel into the abdomen are carried out. 9. irrigation the surgical field with a dilute anti-biotics or antiseptics and closure of the defect by continuous sutures using vicryl or prolene sutures 10. Closure of the wound

Group B

Experimental group

Description:

1. Good preparation of the patient preoperative 2. Performing an opening in the skin surrounding the stoma 3-4 mm from the muco-cutaneous junctions. 3. Separate the bowel loop away from its attachment to the abdomen wall. 4. Cut out a rim of 0.3-0.4 cm of scarred bowel edges exposes healthful tissue. 5. Avoid any spillage or soiling 6. Closing of bowel defect can be made by double layer of 3-0 vicryl interrupted. 7. Once the tissue is of poor quality for simply closing, we expand the incision in the abdomen wall and resect a section. An end-to-end anastomosis is created using the conventional 2-layers suture method. 8. Reduction of the bowel into the abdomen are carried out. 9. irrigation the surgical field with a dilute anti-biotics or antiseptics and closure of the defect by continuous sutures using vicryl or prolene sutures 10. mesh is simply fixed over the defect as a tension-free patch (onlay) 11. Closure of the wound

Treatment:

Device: Prolene mesh