Surgical Mesh in Radical Cystectomy to Prevent Parastomal Hernias

NCT ID: NCT06032910

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

Bladder Cancer; Hernia; Ileal Conduit

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

Patients who receive prophylactic mesh during the surgery.

Group Type: EXPERIMENTAL

Surgical mesh

Intervention Type: DEVICE

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

Interventions

Surgical mesh

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• different than surgical therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Hradec Kralove

Hradec Králové, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Pavel Navratil, M.D.

Role: CONTACT

pavel.navratil2@fnhk.cz

00420495833378

Facility Contacts

Pavel Navratil, M.D.

Role: primary

pavel.navratil2@fnhk.cz

00420495833378

Related Links

https://www.fnhk.cz/urol

Department's website

Other Identifiers

Mesh_RACE

Identifier Type: -

Identifier Source: org_study_id