Clinical trial NCT06157645: Prophylactic Mesh Reinforcement for Stoma Closure
Official title: Prophylactic Mesh Reinforcement for Stoma Closure Versus Anatomical Closure a Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Incisional Hernia
Surgical Site Infection
Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: the risk of developing surgical site incisional hernia (SSIH)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: surgical site infection
timeFrame: Up to 12 weeks
measure: post-operative Pain
timeFrame: immediately after the intervention
measure: Hospital stay
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mostafa Thabet, Professor
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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.
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.
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.