Prophylactic Mesh Reinforcement for Stoma Closure

NCT06157645 | Completed DMC

• 1 other identifier: Mesh with stoma closur
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Stoma closure; Stoma reversal; Loop ileostomy; Prophylactic mesh; Onlay mesh; Incisional hernia; Abdominal wall reinforcement; Anatomical closure; Randomized controlled trial; Surgical outcomes

Outcome Measures

Primary Outcomes (1)

• Incisional (stoma-site) hernia rate

  Proportion of participants developing an incisional hernia at the stoma site, confirmed by physical examination or imaging (ultrasound/CT).

  Up to 12 months postoperatively

Secondary Outcomes (6)

• 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)

Study Arms (2)

Group A

NO INTERVENTION

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

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

Device: Prolene mesh

Interventions

Prolene mesh DEVICE

Application of mesh onlay post stoma closure

Group B

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are fit for aesthesia.
• Patients with temporary double barrelled and simple loop ostomy
• Patients older than 16 years old

You may not qualify if:

• Patients with end ostomy
• Infected stomas

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospitals

Asyut, Asyut Governorate, Egypt

Location

Related Publications (6)

• Chow A, Tilney HS, Paraskeva P, Jeyarajah S, Zacharakis E, Purkayastha S. The morbidity surrounding reversal of defunctioning ileostomies: a systematic review of 48 studies including 6,107 cases. Int J Colorectal Dis. 2009 Jun;24(6):711-23. doi: 10.1007/s00384-009-0660-z. Epub 2009 Feb 17.

  PMID: 19221766 BACKGROUND

• Williams NS, Nasmyth DG, Jones D, Smith AH. De-functioning stomas: a prospective controlled trial comparing loop ileostomy with loop transverse colostomy. Br J Surg. 1986 Jul;73(7):566-70. doi: 10.1002/bjs.1800730717.

  PMID: 3524742 BACKGROUND

• Reinforcement of Closure of Stoma Site (ROCSS) Collaborative and the West Midlands Research Collaborative. Randomized controlled trial of standard closure of a stoma site vs biological mesh reinforcement: study protocol of the ROCSS trial. Colorectal Dis. 2018 Feb;20(2):O46-O54. doi: 10.1111/codi.13997.

  PMID: 29314655 BACKGROUND

• Mohamedahmed AYY, Stonelake S, Zaman S, Hajibandeh S. Closure of stoma site with or without prophylactic mesh reinforcement: a systematic review and meta-analysis. Int J Colorectal Dis. 2020 Aug;35(8):1477-1488. doi: 10.1007/s00384-020-03681-0. Epub 2020 Jun 25.

  PMID: 32588121 BACKGROUND

• Liu DS, Banham E, Yellapu S. Prophylactic mesh reinforcement reduces stomal site incisional hernia after ileostomy closure. World J Surg. 2013 Sep;37(9):2039-45. doi: 10.1007/s00268-013-2109-3.

  PMID: 23716028 BACKGROUND

• Lee JH, Ahn BK, Lee KH. Complications Following the Use of Biologic Mesh in Ileostomy Closure: A Retrospective, Comparative Study. Wound Manag Prev. 2020 Jun;66(6):16-22.

  PMID: 32511101 BACKGROUND

MeSH Terms

Conditions

Incisional Hernia; Surgical Wound Infection; Pain, Postoperative

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Wound Infection; Infections; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mostafa Thabet, Professor

  Assiut University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Neither the participants, the treating surgeons, nor the outcome assessors are blinded to the assigned intervention due to the surgical nature of the procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Participants are randomized into two parallel groups. The intervention group undergoes stoma reversal with prophylactic onlay Prolene mesh reinforcement, while the control group undergoes standard anatomical closure without mesh. Each participant receives only one assigned surgical technique, and outcomes are compared between the two groups.

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: December 6, 2023
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-11

Locations

EG (1)