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Surgical Mesh in Radical Cystectomy to Prevent Parastomal Hernias

Primary Purpose

Bladder Cancer, Hernia, Ileal Conduit

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Surgical mesh
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring radical cystectomy, ileal conduit, parastomal hernia, mesh

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: muscle-invasive or high-risk non-muscle-invasive bladder cancer patients Exclusion Criteria: different than surgical therapy

Sites / Locations

  • University Hospital Hradec KraloveRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

Patients who receive prophylactic mesh during the surgery.

Outcomes

Primary Outcome Measures

Parastomal hernia
Incidence after surgery

Secondary Outcome Measures

Full Information

First Posted
September 5, 2023
Last Updated
September 12, 2023
Sponsor
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT06032910
Brief Title
Surgical Mesh in Radical Cystectomy to Prevent Parastomal Hernias
Official Title
The Use of Surgical Mesh in Open Radical Cystectomy With Ileal Conduit Urinary Diversion to Prevent Parastomal Hernias
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Hernia, Ileal Conduit
Keywords
radical cystectomy, ileal conduit, parastomal hernia, mesh

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients who receive prophylactic mesh during the surgery.
Intervention Type
Device
Intervention Name(s)
Surgical mesh
Intervention Description
Prophylactic synthetic non-absorbable keyhole mesh placement upon construction of ileal conduit.
Primary Outcome Measure Information:
Title
Parastomal hernia
Description
Incidence after surgery
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: muscle-invasive or high-risk non-muscle-invasive bladder cancer patients Exclusion Criteria: different than surgical therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pavel Navratil, M.D.
Phone
00420495833378
Email
pavel.navratil2@fnhk.cz
Facility Information:
Facility Name
University Hospital Hradec Kralove
City
Hradec Králové
ZIP/Postal Code
50005
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Navratil, M.D.
Phone
00420495833378
Email
pavel.navratil2@fnhk.cz

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.fnhk.cz/urol
Description
Department's website

Learn more about this trial

Surgical Mesh in Radical Cystectomy to Prevent Parastomal Hernias

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