Bladder CancerTURBT-BPNCT04129606
Bladder Perforation Post-TURBT: Definition, Incidence and Natural HistoryStudy
A study testing Computed tomographic cystography in people with Bladder Cancer and Bladder Urothelial Carcinoma, run by Abdelwahab Hashem at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Bladder Urothelial Carcinoma, Trauma
- What is being tested?
- Computed tomographic cystography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- papillary bladder tumor (denovo or recurrent)
- resectable nodular bladder tumor
Who cannot join
- Refuse to complete study requirements
- muscle invasive bladder tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bladder Perforation Post-TURBT: Definition, Incidence and Natural History. A Prospective Cohort Study
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
- Conditions
- Bladder Cancer, Bladder Urothelial Carcinoma, Trauma, Injuries, Perforation of Bladder, Recurrence Tumor
- Being tested
- Computed tomographic cystography
- Keywords
- Perforation of Bladder, Bladder Cancer, Resection Margin
- Medical subject headings
- Urinary Bladder Neoplasms, Wounds and Injuries, Recurrence, Margins of Excision, Neoplasm Seeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomographic cystographyDiagnostic test
Also called CT cystography
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.
| Study group | Role | What they receive |
|---|---|---|
| TURBT | Other | Transurethral resection of bladder tumour Receives: Diagnostic Test: Computed tomographic cystography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (2)
Correlation between the cystoscopical and radiological bladder perforation
compare the numbers of bladder perforation diagnosed by CT cystogram by the number of bladder perforation described by surgeon
Measured: 24 months
assess the recurrence free rate in bladder perforation groups at 2 year follow up
calculate the number of recurrence pf bladder tumor in bladder perforation at 2 year follow up
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Jul 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdelwahab Hashem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelwahab Hashem, Mansoura University
- Investigators
- Nasr Eltabey, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129606
- Sponsor's protocol ID
- TURBT-BP
- Acronym
- TURBT-BP
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Perforation Post-TURBT: Definition, Incidence and Natural History. A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04129606
- Acronym / sponsor ID
- TURBT-BP / TURBT-BP
- Conditions
- Bladder Cancer, Bladder Urothelial Carcinoma, Trauma, Injuries, Perforation of Bladder, Recurrence Tumor
- Keywords
- Perforation of Bladder, Bladder Cancer, Resection Margin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Abdelwahab HashemUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TURBT | Other | Diagnostic Test: Computed tomographic cystographyTransurethral resection of bladder tumour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- papillary bladder tumor (denovo or recurrent)
- resectable nodular bladder tumor
Key exclusion criteria (2 listed)
- Refuse to complete study requirements
- muscle invasive bladder tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomographic cystographyAlso: CT cystographyCT 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. | Diagnostic test | TURBT |
Primary outcome
Prevalence of bladder perforation post-Transurethral resection of bladder tumour
Time frame: 24 months
calculate the numbers of bladder perforation diagnosed by CT cystogram divided by the total number of patients
2 secondary outcomes
Correlation between the cystoscopical and radiological bladder perforation
Time frame: 24 months
assess the recurrence free rate in bladder perforation groups at 2 year follow up
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasr Eltabey, MD principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed tomographic cystography in people with Bladder Cancer and Bladder Urothelial Carcinoma, run by Abdelwahab Hashem at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of bladder perforation post-Transurethral resection of bladder tumour (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.