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OpenTrials
Completed

NCT Number: NCT06157645

Prophylactic Mesh Reinforcement for 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 surgical site incisional hernia (SSIH),incidence of surgical site infection , post-operative Pain and Hospital stay

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolene mesh

Device

Application of mesh onlay post stoma closure

Primary outcomes

  1. 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

  1. Surgical site infection rate

    Time frame: Within 30 days postoperatively

    Rate of postoperative infections at the stoma closure site

  2. 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).

  3. Length of hospital stay

    Time frame: through study completion, an average of 2 years

    Number of days spent in hospital following surgery.

  4. 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.

  5. Operative time

    Time frame: Intraoperative (from skin incision to skin closure)

    Total duration of surgery measured in minutes.

  6. Intraoperative blood loss

    Time frame: through study completion, an average of 2 years

    During surgery

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: OASIS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2023
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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