Study Results
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Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2024-09-01
2025-09-01
Brief Summary
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Reducing the Incidence of Incisional Hernia After Stoma Closure Using a Prophylactic Mesh
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
No interventions assigned to this group
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
Prolene mesh
Application of mesh onlay post stoma closure
Interventions
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Prolene mesh
Application of mesh onlay post stoma closure
Eligibility Criteria
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Inclusion Criteria
* Patients with temporary double barrelled and simple loop ostomy
* Patients older than 16 years old
Exclusion Criteria
* Infected stomas
16 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mahmoud Abdelwahed Abdeljaber
Principal investigator
Principal Investigators
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Mostafa Thabet, Professor
Role: STUDY_CHAIR
Assiut University
Locations
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Assiut university hospitals
Asyut, Asyut Governorate, Egypt
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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Mesh with stoma closur
Identifier Type: -
Identifier Source: org_study_id
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