Assiut university hospitals
Asyut, Asyut Governorate, Egypt
NCT Number: NCT06157645
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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Notify Me16 year and older
All sexes
Interventional
Not applicable
Asyut, Asyut Governorate, Egypt
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Application of mesh onlay post stoma closure
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).
Time frame: Within 30 days postoperatively
Rate of postoperative infections at the stoma closure site
Time frame: Daily for the first 7 postoperative days
Pain at the stoma closure site measured using the Visual Analog Scale (VAS).
Time frame: through study completion, an average of 2 years
Number of days spent in hospital following surgery.
Time frame: Within 30 days postoperatively
Any postoperative complications, including wound dehiscence, ileus, bowel obstruction, or reoperation, graded according to Clavien-Dindo classification.
Time frame: Intraoperative (from skin incision to skin closure)
Total duration of surgery measured in minutes.
Time frame: through study completion, an average of 2 years
During surgery
Assiut University
Other
Prophylactic Onlay Mesh Reinforcement vs Anatomical Closure in Stoma Reversal: A Randomized Controlled Trial
Acronym: OASIS
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