Surgical Mesh in Radical Cystectomy to Prevent Parastomal Hernias

Sponsor

Charles University, Czech Republic (Other)

Overall Status

Recruiting

CT.gov ID

NCT06032910

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Hernia Ileal Conduit	Device: Surgical mesh	N/A

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

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group Patients who receive prophylactic mesh during the surgery.	Device: Surgical mesh Prophylactic synthetic non-absorbable keyhole mesh placement upon construction of ileal conduit.

Arm

Intervention/Treatment

Experimental: Study group

Patients who receive prophylactic mesh during the surgery.

Device: Surgical mesh

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

Outcome Measures

Primary Outcome Measures

Parastomal hernia [12 months]
Incidence after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

different than surgical therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Hradec Kralove	Hradec Králové		Czechia	50005

Sponsors and Collaborators

Charles University, Czech Republic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Department's website

Publications

None provided.

Responsible Party:

Charles University, Czech Republic

ClinicalTrials.gov Identifier:

NCT06032910

Other Study ID Numbers:

Mesh_RACE

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 14, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Charles University, Czech Republic

Additional relevant MeSH terms:

Hernia

Study Results

No Results Posted as of Sep 14, 2023