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
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring radical cystectomy, ileal conduit, parastomal hernia, mesh
Eligibility Criteria
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
NCT ID
NCT06032910
First Posted
September 5, 2023
Last Updated
September 12, 2023
Sponsor
Charles University, Czech Republic
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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