NCT04129606

Brief Summary

In view of sparse data of precise definition, risk factors, natural history and management of bladder perforation following Transurethral resection of bladder tumour (TURBT). We aim to correlate the relation between the site, depth and extent of resection with bladder perforation. Also, correlation between vertical depth, horizontal extent of resection and recurrence and progression of tumor

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

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

July 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

October 15, 2019

Last Update Submit

October 15, 2019

Conditions

Bladder CancerBladder Urothelial CarcinomaTraumaInjuriesPerforation of BladderRecurrence TumorResection MarginSeeding, Neoplasm

Keywords

Perforation of BladderBladder CancerResection Margin

Outcome Measures

Primary Outcomes (1)

  • Prevalence of bladder perforation post-Transurethral resection of bladder tumour

    calculate the numbers of bladder perforation diagnosed by CT cystogram divided by the total number of patients

    24 months

Secondary Outcomes (2)

  • Correlation between the cystoscopical and radiological bladder perforation

    24 months

  • assess the recurrence free rate in bladder perforation groups at 2 year follow up

    24 months

Study Arms (1)

TURBT

OTHER

Transurethral resection of bladder tumour

Diagnostic Test: Computed tomographic cystography

Interventions

Computed tomographic cystographyDIAGNOSTIC_TEST

CT cystogram performed after the procedure by the injection of 400mL of 1/4 saline-diluted contrast solution (meglumine ioxitalamate) with low-pressure infusion (60 cm gravity pressure) through the Foley catheter.

Also known as: CT cystography
TURBT

Eligibility Criteria

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

You may qualify if:

  • papillary bladder tumor (denovo or recurrent)
  • resectable nodular bladder tumor

You may not qualify if:

  • Refuse to complete study requirements
  • muscle invasive bladder tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsWounds and InjuriesRecurrenceMargins of ExcisionNeoplasm Seeding

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMorphological and Microscopic FindingsNeoplasm MetastasisNeoplastic Processes

Study Officials

  • Nasr Eltabey, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 17, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

October 17, 2019

Record last verified: 2019-10

Locations

EG(1)