Prophylactic Mesh Reinforcement for Stoma Closure

Postoperative Pain Clinical Trial

Official title:

Prophylactic Mesh Reinforcement for Stoma Closure Versus Anatomical Closure a Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06157645
• Other study ID #: Mesh with stoma closur
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: November 1, 2026

Study information

• Verified date: December 2023
• Source: Assiut University
• Contact: Mahmoud Abdelwahed
• Phone: 01156034745
• Email: Mahmoud.a.wahed[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

n 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Incisional Hernia
• Postoperative Pain
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Device:
• Prolene mesh
Application of mesh onlay post stoma closure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the risk of developing surgical site incisional hernia (SSIH)	Compare between the incidence of surgical site incisional hernia in group a and group b	through study completion, an average of 1 year
Secondary	surgical site infection	Compare between the incidence of surgical site infection in group a and group b	Up to 12 weeks
Secondary	post-operative Pain	Compare between the incidence of post operative pain in group a and group b using numeric pain rating scale from 0 to 10	immediately after the intervention
Secondary	Hospital stay	Compare between the lenght of hospital stay post operative in group a and group b	through study completion, an average of 1 year