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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06032910
Other study ID # Mesh_RACE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source Charles University, Czech Republic
Contact Pavel Navratil, M.D.
Phone 00420495833378
Email pavel.navratil2@fnhk.cz
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - muscle-invasive or high-risk non-muscle-invasive bladder cancer patients Exclusion Criteria: - different than surgical therapy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Surgical mesh
Prophylactic synthetic non-absorbable keyhole mesh placement upon construction of ileal conduit.

Locations

Country Name City State
Czechia University Hospital Hradec Kralove Hradec Králové

Sponsors (1)

Lead Sponsor Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parastomal hernia Incidence after surgery 12 months
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