Bladder CancerNCT04406168
Assessment of Urinary Diversions Outcomes Post Radical Cystectomy in Asyut University Urology Hospital
An observational study of Bladder Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
Radical cystectomy (RC) for bladder cancer requires reconstruction of the lower urinary tract. Both continent and incontinent diversions are available for urinary reconstruction after RC. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- urinary diversion
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 1 May 2023
- Phase
- Observational
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: All cases that fulfil the selection criteria that have been admitted in Asyut university urology hospital (non probability sample size) with expected size of 40 patients starting from 01/01/2013 to1/05/2020. Additionally, the competence of follow-up will be approved by imaging and medical records.
Who may be able to join
- * All patients underwent radical cystectomy more than 1 year
Who cannot join
- incomplete data
- patients underwent RC outside urology department and presented for treatment of complications.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, Elgam3a, 11174
tarek m elgamaal
About this study
Radical cystectomy (RC) for bladder cancer requires reconstruction of the lower urinary tract. Both continent and incontinent diversions are available for urinary reconstruction after RC. Types of urinary diversions include ( ileal conduit, uretero-cutaneous, ureterosigmoidostomy and orthotopic bladder) The decision process is complex and involves consideration of issues related to cancer stage, patient comorbidities, treatment needs, and patient desires related to Quality of life and intraoperative findings. Outcomes of urinary diversions include 1- survival rate (cancer specific or overall survival). 2- Oncological failure (local, distant or LNs). 3- Complications (perioperative, intraoperative or post-operative).
In this study, all these outcomes will be analyzed.
- Conditions
- Bladder Cancer
- Being tested
- urinary diversion
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary diversionProcedure or surgery
follow up outcomes of urinary diversion
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients presented by complications
such as (change from baseline of the SCR - urinary tract infections - stone formation - stricture at site of anastomosis or stromal stenosis )
Measured: 1 year post operative
Rate of patients developed recurrence
recurrence of cancer
Measured: 1 year post operative
Survival rate (overall survival & cancer specific)
patient live post operative
Measured: 1 year post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2023 (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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mahmoud Abdellah, Assiut University
- Investigators
- salah s abdelhafez, Study director, prof
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406168
- Sponsor's protocol ID
- urinary diversions outcomes
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Urinary Diversions Outcomes Post Radical Cystectomy in Asyut University Urology Hospital
- ClinicalTrials.gov ID
- NCT04406168
- Acronym / sponsor ID
- urinary diversions outcomes
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 28 May 2020 (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.
Radical cystectomy (RC) for bladder cancer requires reconstruction of the lower urinary tract. Both continent and incontinent diversions are available for urinary reconstruction after RC. Types of urinary diversions include ( ileal conduit, uretero-cutaneous, ureterosigmoidostomy and orthotopic bladder) The decision process is complex and involves consideration of issues related to cancer stage, patient comorbidities, treatment needs, and patient desires related to Quality of life and intraoperative findings. Outcomes of urinary diversions include 1- survival rate (cancer specific or overall survival). 2- Oncological failure (local, distant or LNs). 3- Complications (perioperative, intraoperative or post-operative).
In this study, all these outcomes will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All cases that fulfil the selection criteria that have been admitted in Asyut university urology hospital (non probability sample size) with expected size of 40 patients starting from 01/01/2013 to1/05/2020. Additionally, the competence of follow-up will be approved by imaging and medical records.
Key inclusion criteria (1 listed)
- * All patients underwent radical cystectomy more than 1 year
Key exclusion criteria (2 listed)
- incomplete data
- patients underwent RC outside urology department and presented for treatment of complications.
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 |
|---|---|---|
| urinary diversionfollow up outcomes of urinary diversion | Procedure or surgery | – |
Primary outcome
Rate of patients presented by complications
Time frame: 1 year post operative
such as (change from baseline of the SCR - urinary tract infections - stone formation - stricture at site of anastomosis or stromal stenosis )
Rate of patients developed recurrence
Time frame: 1 year post operative
recurrence of cancer
Survival rate (overall survival & cancer specific)
Time frame: 1 year post operative
patient live post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
salah s abdelhafez study director
prof
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Assiut University 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 1 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 28 May 2020. 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?
Contact islam m abdellah (+201090088672, islam01183@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients presented by complications (time frame: 1 year post operative). The study lists 3 primary outcomes in all. 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 28 May 2020.