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Clinical Trials/NCT06032910
NCT06032910UnknownNot Applicable

The Use of Surgical Mesh in Open Radical Cystectomy With Ileal Conduit Urinary Diversion to Prevent Parastomal Hernias

Charles University, Czech Republic2 sites in 1 country25 target enrollmentStarted: January 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
25
Locations
2
Primary Endpoint
Parastomal hernia

Study Overview

Brief Summary

Radical cystectomy with ileal conduit urinary diversion serves as a foundational curative treatment strategy for selected patients afflicted with urothelial carcinoma of the bladder. Parastomal hernia after this procedure is an underestimated and undertreated clinical entity, which heavily impairs patients' quality of life due to symptoms of pain, leakage, application or skin problems. There is little evidence about prophylactic mesh placement for parastomal hernia prevention. In this study we examine the use of meshes during radical cystectomy and compare them with a control group.

Detailed Description

Radical cystectomy with ileal conduit diversion is a procedure possible with complications. A primary stoma-related complication is the parastomal hernia (PH), which presents significant challenges to both the medical community and the patient. PH is classically defined as the protrusion of abdominal contents via the abdominal wall, especially in the direct vicinity of a stoma, whether it be a colostomy, ileostomy, or ileal conduit stoma. The incidence of PH post ileal conduit urinary diversion is especially concerning, with reports estimating its occurrence at around 17%. This data only emphasizes the need to reevaluate and optimize surgical treatments for PH, particularly as, in many cases, management strategies are extrapolated from experiences with colostomies or ileostomies. Notably, PHs are often described after these procedures rather than RC with ileal conduit urinary diversion. Further complicating the issue is the fact that estimates suggest around 30% of patients develop a PH within 12 months post any type of stoma site surgery. For those undergoing ileal conduit urinary diversion specifically, recurrence rates following PH repair can be alarmingly high, with figures as steep as 69% within a year.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • muscle-invasive or high-risk non-muscle-invasive bladder cancer patients

Exclusion Criteria

  • different than surgical therapy

Arms & Interventions

Study group

Experimental

Patients who receive prophylactic mesh during the surgery.

Intervention: Surgical mesh (Device)

Outcomes

Primary Outcomes

Parastomal hernia

Time Frame: 12 months

Incidence after surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Charles University, Czech Republic
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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