Patient SatisfactionNCT04610385
Ileal Conduit Versus Cutaneous Ureterostomy After Radical Cystectomy
An observational study of Patient Satisfaction and Bladder Cancer, run by Assiut University.
Trial summary
Bladder cancer is the most common malignancy of the urinary tract and accounts for about 3.2% of all cancer worldwide where it remains the seventh most commonly diagnosed malignancy in the male population. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Patient Satisfaction, Bladder Cancer
- What is being tested?
- radical cystectomy with urinary diversion
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 30 Oct 2022
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bladder cancer eligible for radical cystectomy and will undergo either ileal conduit or unilateral cutaneous ureterostomy with separate stomas with age range from 45 to 85 years regardless of gender.
Who may be able to join
- patients with bladder cancer eligible for surgery
Who cannot join
- Patients who refuse to contribute in this study.
- patients who are unfit for surgery.
- patients refusing cystectomy.
- patients with metastatic or inoperable cancer bladder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Ileal Conduit and Unilateral Cutaneous Ureterostomy With Separate Stomas Post Radical Cystectomy
Bladder cancer is the most common malignancy of the urinary tract and accounts for about 3.2% of all cancer worldwide where it remains the seventh most commonly diagnosed malignancy in the male population. Causative risk factors can be broadly divided into inherited and acquired due to environmental exposure ,Tobacco smoking is the most important environmental risk factor for bladder cancer(1).
Histologically, over 90% of bladder tumors are transitional cell carcinomas. The other subtypes, such as squamous cell and adenocarcinoma, are uncommon and account for 5 and <2%, respectively(2).
Read more
Radical cystectomy with pelvic lymph node dissection with appropriate urinary diversion remains the mainstay of surgical treatment for muscle invasive bladder cancer and for high risk non muscle invasive disease. Select group of patients or those unfit or unwilling for surgery are managed by trimodal therapy utilizing transurethral resection and chemoradiotherapy.(3) The ideal urinary diversion should successfully preserve renal function while managing urinary outflow and minimizing morbidity to the patient(4).Several types of urinary diversion are present, continent and incontinent. Our study will focus on ileal conduit and cutaneous ureterostomy.
Although ileal conduit considered the standard method for incontinent urinary diversion, it is associated with early bowel related complications, i.e., bowel obstruction, prolonged ileus, and anastomotic leak which are mainly associated with bowel resection and anastomosis and late complications comprise ureteroenteric stricture, urinary fistula and stomal site complications in 25-60% of patients, including stomal stenosis, retraction, prolapsed, and parastomal herniation. Cutaneous ureterostomy may represent a method of choice for elderly and otherwise morbid patients due to its relative short duration and less bowel and metabolic complications but it has a high rate of stomal stenosis making perminant stenting is mandatory(5).
Cutaneous ureterostomy with separate stomas offers easy exchange of stents not need tertiary center with fluoroscopy or endescopy guidance compared to cutaneous ureterostomy with single stoma and this is preferable in our community.
- Conditions
- Patient Satisfaction, Bladder Cancer
- Being tested
- radical cystectomy with urinary diversion
- Medical subject headings
- Patient Satisfaction, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radical cystectomy with urinary diversionProcedure or surgery
surgical removal of the urinary bladder and other organs and perform a urinary shunt
| Study group | Role | What they receive |
|---|---|---|
| ileal conduit | Not described Receives: Procedure: radical cystectomy with urinary diversion | |
| cutaneous ureterostomy | Not described Receives: Procedure: radical cystectomy with urinary diversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life measure
using FAST-BCI
Measured: 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mena Hosam Mahdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610385
- Sponsor's protocol ID
- bladder caner treatment
- Status last verified
- Oct 2020
- First submitted
- 28 Aug 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tsaturyan A, Sahakyan S, Muradyan A, Fanarjyan S, Tsaturyan A. A new modification of tubeless cutaneous ureterostomy following radical cystectomy. Int Urol Nephrol. 2019 Jun;51(6):959-967. doi: 10.1007/s11255-019-02145-x. Epub 2019 Apr 13.
PubMed 30982146Moeen AM, Safwat AS, Gadelmoula MM, Moeen SM, Abonnoor AEI, Abbas WM, ElGanainy EO, El-Taher AM. Health related quality of life after urinary diversion. Which technique is better? J Egypt Natl Canc Inst. 2018 Sep;30(3):93-97. doi: 10.1016/j.jnci.2018.08.001. Epub 2018 Aug 23.
PubMed 30145025Lee RK, Abol-Enein H, Artibani W, Bochner B, Dalbagni G, Daneshmand S, Fradet Y, Hautmann RE, Lee CT, Lerner SP, Pycha A, Sievert KD, Stenzl A, Thalmann G, Shariat SF. Urinary diversion after radical cystectomy for bladder cancer: options, patient selection, and outcomes. BJU Int. 2014 Jan;113(1):11-23. doi: 10.1111/bju.12121.
PubMed 24330062
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Ileal Conduit and Unilateral Cutaneous Ureterostomy With Separate Stomas Post Radical Cystectomy
- ClinicalTrials.gov ID
- NCT04610385
- Acronym / sponsor ID
- bladder caner treatment
- Conditions
- Patient Satisfaction, Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 30 Oct 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.
Bladder cancer is the most common malignancy of the urinary tract and accounts for about 3.2% of all cancer worldwide where it remains the seventh most commonly diagnosed malignancy in the male population. Causative risk factors can be broadly divided into inherited and acquired due to environmental exposure ,Tobacco smoking is the most important environmental risk factor for bladder cancer(1).
Histologically, over 90% of bladder tumors are transitional cell carcinomas. The other subtypes, such as squamous cell and adenocarcinoma, are uncommon and account for 5 and <2%, respectively(2).
Radical cystectomy with pelvic lymph node dissection with appropriate urinary diversion remains the mainstay of surgical treatment for muscle invasive bladder cancer and for high risk non muscle invasive disease. Select group of patients or those unfit or unwilling for surgery are managed by trimodal therapy utilizing transurethral resection and chemoradiotherapy.(3) The ideal urinary diversion should successfully preserve renal function while managing urinary outflow and minimizing morbidity to the patient(4).Several types of urinary diversion are present, continent and incontinent. Our study will focus on ileal conduit and cutaneous ureterostomy.
Although ileal conduit considered the standard method for incontinent urinary diversion, it is associated with early bowel related complications, i.e., bowel obstruction, prolonged ileus, and anastomotic leak which are mainly associated with bowel resection and anastomosis and late complications comprise ureteroenteric stricture, urinary fistula and stomal site complications in 25-60% of patients, including stomal stenosis, retraction, prolapsed, and parastomal herniation. Cutaneous ureterostomy may represent a method of choice for elderly and otherwise morbid patients due to its relative short duration and less bowel and metabolic complications but it has a high rate of stomal stenosis making perminant stenting is mandatory(5).
Cutaneous ureterostomy with separate stomas offers easy exchange of stents not need tertiary center with fluoroscopy or endescopy guidance compared to cutaneous ureterostomy with single stoma and this is preferable in our community.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ileal conduit | – | Procedure: radical cystectomy with urinary diversion |
| cutaneous ureterostomy | – | Procedure: radical cystectomy with urinary diversion |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bladder cancer eligible for radical cystectomy and will undergo either ileal conduit or unilateral cutaneous ureterostomy with separate stomas with age range from 45 to 85 years regardless of gender.
Key inclusion criteria (1 listed)
- patients with bladder cancer eligible for surgery
Key exclusion criteria (4 listed)
- Patients who refuse to contribute in this study.
- patients who are unfit for surgery.
- patients refusing cystectomy.
- patients with metastatic or inoperable cancer bladder
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 |
|---|---|---|
| radical cystectomy with urinary diversionsurgical removal of the urinary bladder and other organs and perform a urinary shunt | Procedure or surgery | cutaneous ureterostomy, ileal conduit |
Primary outcome
quality of life measure
Time frame: 1 year postoperative
using FAST-BCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Background: PubMed 30982146Tsaturyan A, Sahakyan S, Muradyan A, Fanarjyan S, Tsaturyan A. A new modification of tubeless cutaneous ureterostomy following radical cystectomy. Int Urol Nephrol. 2019 Jun;51(6):959-967. doi: 10.1007/s11255-019-02145-x. Epub 2019 Apr 13.
- Background: PubMed 30145025Moeen AM, Safwat AS, Gadelmoula MM, Moeen SM, Abonnoor AEI, Abbas WM, ElGanainy EO, El-Taher AM. Health related quality of life after urinary diversion. Which technique is better? J Egypt Natl Canc Inst. 2018 Sep;30(3):93-97. doi: 10.1016/j.jnci.2018.08.001. Epub 2018 Aug 23.
- Background: PubMed 24330062Lee RK, Abol-Enein H, Artibani W, Bochner B, Dalbagni G, Daneshmand S, Fradet Y, Hautmann RE, Lee CT, Lerner SP, Pycha A, Sievert KD, Stenzl A, Thalmann G, Shariat SF. Urinary diversion after radical cystectomy for bladder cancer: options, patient selection, and outcomes. BJU Int. 2014 Jan;113(1):11-23. doi: 10.1111/bju.12121.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction and Bladder Cancer, run by Assiut University.
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 4 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 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Mena H Mahdy, resident (01008413768, menaahosam1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life measure (time frame: 1 year postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04610385, which also lists 3 linked publications.
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 30 Oct 2020.