Prophylactic Mesh Reinforcement for Stoma Closure | NCT06157645

NCT06157645

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	No Intervention	Good preparation of the patient preoperative Performing an opening in the skin surrounding the stoma 3-4 mm from the muco-cutaneous junctions. Separate the bowel loop away from its attachment to the abdomen wall. Cut out a rim of 0.3-0.4 cm of scarred bowel edges exposes healthful tissue. Avoid any spillage or soiling Closing of bowel defect can be made by double layer of 3-0 vicryl interrupted. 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. Reduction of the bowel into the abdomen are carried out. irrigation the surgical field with a dilute anti-biotics or antiseptics and closure of the defect by continuous sutures using vicryl or prolene sutures Closure of the wound
Group B	Experimental	Good preparation of the patient preoperative Performing an opening in the skin surrounding the stoma 3-4 mm from the muco-cutaneous junctions. Separate the bowel loop away from its attachment to the abdomen wall. Cut out a rim of 0.3-0.4 cm of scarred bowel edges exposes healthful tissue. Avoid any spillage or soiling Closing of bowel defect can be made by double layer of 3-0 vicryl interrupted. 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. Reduction of the bowel into the abdomen are carried out. irrigation the surgical field with a dilute anti-biotics or antiseptics and closure of the defect by continuous sutures using vicryl or prolene sutures mesh is simply fixed over the defect as a tension-free patch (onlay) Closure of the wound	Device: Prolene mesh

Name	Type	Description	Arm Group Labels	Other Names
Prolene mesh	Device	Application of mesh onlay post stoma closure	Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incisional (stoma-site) hernia rate	Proportion of participants developing an incisional hernia at the stoma site, confirmed by physical examination or imaging (ultrasound/CT).	Up to 12 months postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Surgical site infection rate	Rate of postoperative infections at the stoma closure site	Within 30 days postoperatively
post-operative Pain	Pain at the stoma closure site measured using the Visual Analog Scale (VAS).

Eligibility Module

Name	Affiliation	Role
Mostafa Thabet, Professor	Assiut University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university hospitals		Asyut	Asyut Governorate		Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19221766	Background	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.
3524742	Background

Condition Browse Module

ID	Term
D000069290	Incisional Hernia
D013530	Surgical Wound Infection
D010149	Pain, Postoperative

ID	Term
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications