NCT06032910

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 28, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

September 5, 2023

Last Update Submit

February 27, 2024

Conditions

Bladder CancerHerniaIleal Conduit

Keywords

radical cystectomyileal conduitparastomal herniamesh

Outcome Measures

Primary Outcomes (1)

  • Parastomal hernia

    Incidence after surgery

    12 months

Study Arms (1)

Study group

EXPERIMENTAL

Patients who receive prophylactic mesh during the surgery.

Device: Surgical mesh

Interventions

Surgical meshDEVICE

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

Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • different than surgical therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

RECRUITING

Related Links

MeSH Terms

Conditions

Urinary Bladder NeoplasmsHernia

Interventions

Surgical Mesh

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Central Study Contacts

Pavel Navratil, M.D.

CONTACT

00420495833378pavel.navratil2@fnhk.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 28, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)