Surgical Mesh in Radical Cystectomy to Prevent Parastomal Hernias

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032910
• Other study ID #: Mesh_RACE
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bladder Cancer
• Hernia
• Ileal Conduit

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

External Links

•   Department's website