Prophylactic Mesh Reinforcement for Stoma Closure (OASIS)

December 10, 2025 updated by: Mahmoud Abdelwahed Abdeljaber, Assiut University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt
        • Assiut University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group A
  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
Experimental: Group B
  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
Application of mesh onlay post stoma closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection rate
Time Frame: Within 30 days postoperatively
Rate of postoperative infections at the stoma closure site
Within 30 days postoperatively
post-operative Pain
Time Frame: Daily for the first 7 postoperative days
Pain at the stoma closure site measured using the Visual Analog Scale (VAS).
Daily for the first 7 postoperative days
Length of hospital stay
Time Frame: through study completion, an average of 2 years
Number of days spent in hospital following surgery.
through study completion, an average of 2 years
Postoperative complications
Time Frame: Within 30 days postoperatively
Any postoperative complications, including wound dehiscence, ileus, bowel obstruction, or reoperation, graded according to Clavien-Dindo classification.
Within 30 days postoperatively
Operative time
Time Frame: Intraoperative (from skin incision to skin closure)
Total duration of surgery measured in minutes.
Intraoperative (from skin incision to skin closure)
Intraoperative blood loss
Time Frame: through study completion, an average of 2 years
During surgery
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Mostafa Thabet, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

September 1, 2025

Study Registration Dates

First Submitted

November 26, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mesh with stoma closur

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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