Incisional HerniaOASISNCT06157645
Prophylactic Mesh Reinforcement for Stoma Closure
A study testing Prolene mesh in people with Incisional Hernia and Surgical Site Infection, run by Assiut University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Incisional Hernia, Surgical Site Infection, Postoperative Pain
- What is being tested?
- Prolene mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are fit for aesthesia.
- Patients with temporary double barrelled and simple loop ostomy
- Patients older than 16 years old
Who cannot join
- Patients with end ostomy
- Infected stomas
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Prolene mesh
- Keywords
- Stoma closure, Stoma reversal, Loop ileostomy, Prophylactic mesh, Onlay mesh, Incisional hernia, Abdominal wall reinforcement, Anatomical closure, Randomized controlled trial, Surgical outcomes
- Medical subject headings
- Incisional Hernia, Surgical Wound Infection, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolene meshDevice
Application of mesh onlay post stoma closure
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Prolene mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional (stoma-site) hernia rate
Proportion of participants developing an incisional hernia at the stoma site, confirmed by physical examination or imaging (ultrasound/CT).
Measured: Up to 12 months postoperatively
Secondary outcomes (6)
Surgical site infection rate
Rate of postoperative infections at the stoma closure site
Measured: Within 30 days postoperatively
post-operative Pain
Pain at the stoma closure site measured using the Visual Analog Scale (VAS).
Measured: Daily for the first 7 postoperative days
Length of hospital stay
Number of days spent in hospital following surgery.
Measured: through study completion, an average of 2 years
Postoperative complications
Any postoperative complications, including wound dehiscence, ileus, bowel obstruction, or reoperation, graded according to Clavien-Dindo classification.
Measured: Within 30 days postoperatively
Operative time
Total duration of surgery measured in minutes.
Measured: Intraoperative (from skin incision to skin closure)
Intraoperative blood loss
During surgery
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Sep 2024
- Primary completion1 Jul 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelwahed Abdeljaber, Assiut University
- Investigators
- Mostafa Thabet, Professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157645
- Sponsor's protocol ID
- Mesh with stoma closur
- Acronym
- OASIS
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19221766Williams 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.
PubMed 3524742Reinforcement 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.
PubMed 29314655Mohamedahmed 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.
PubMed 32588121Liu 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.
PubMed 23716028Lee 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.
PubMed 32511101
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Onlay Mesh Reinforcement vs Anatomical Closure in Stoma Reversal: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06157645
- Acronym / sponsor ID
- OASIS / Mesh with stoma closur
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Prolene mesh1. 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are fit for aesthesia.
- Patients with temporary double barrelled and simple loop ostomy
- Patients older than 16 years old
Key exclusion criteria (2 listed)
- Patients with end ostomy
- Infected stomas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolene meshApplication of mesh onlay post stoma closure | Device | Group B |
Primary outcome
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).
6 secondary outcomes
Surgical site infection rate
Time frame: Within 30 days postoperatively
post-operative Pain
Time frame: Daily for the first 7 postoperative days
Length of hospital stay
Time frame: through study completion, an average of 2 years
Postoperative complications
Time frame: Within 30 days postoperatively
Operative time
Time frame: Intraoperative (from skin incision to skin closure)
Intraoperative blood loss
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 19221766Chow 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.
- Background: PubMed 3524742Williams 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.
- Background: PubMed 29314655Reinforcement 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.
- Background: PubMed 32588121Mohamedahmed 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.
- Background: PubMed 23716028Liu 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.
- Background: PubMed 32511101Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa Thabet, Professor study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolene mesh in people with Incisional Hernia and Surgical Site Infection, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional (stoma-site) hernia rate (time frame: Up to 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06157645, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.