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NCT06157645 | NOT YET RECRUITING | Incisional Hernia


Prophylactic Mesh Reinforcement for Stoma Closure
Sponsor:

Assiut University

Information provided by (Responsible Party):

Mahmoud Abdul Wahid Abdul -Jabr

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

Condition or disease

Incisional Hernia

Surgical Site Infection

Postoperative Pain

Intervention/treatment

Prolene mesh

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Prophylactic Mesh Reinforcement for Stoma Closure Versus Anatomical Closure a Prospective Study
Actual Study Start Date : 2024-08-01
Estimated Primary Completion Date : 2026-08-01
Estimated Study Completion Date : 2026-11-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 16 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

Prophylactic Mesh Reinforcement for Stoma Closure

Location Details

NCT06157645


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