Skip to content

Surgical Mesh in Radical Cystectomy to Prevent Parastomal Hernias

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06032910
Enrollment
25
Registered
2023-09-13
Start date
2023-01-01
Completion date
2024-12-31
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Hernia, Ileal Conduit

Keywords

radical cystectomy, ileal conduit, parastomal hernia, mesh

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.

Interventions

DEVICESurgical mesh

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

Sponsors

Charles University, Czech Republic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* different than surgical therapy

Design outcomes

Primary

MeasureTime frameDescription
Parastomal hernia12 monthsIncidence after surgery

Countries

Czechia

Contacts

Primary ContactPavel Navratil, M.D.
pavel.navratil2@fnhk.cz00420495833378

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026