Urinary Bladder CancerNCT06115434
Comparing Operative, Postoperative and Quality of Life of Patients After Salvage and Radical Cystectomy
An observational study of Urinary Bladder Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
To compare operative difficulties, type of urinary diversion, intraoperative \& postoperative complications and quality of life in patients underwent radical cystectomy and those after salvage cystectomy. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Urinary Bladder Cancer
- What is being tested?
- cystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2015to 31 Dec 2024
- How long will I take part?
- 6 Months
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with muscle invasive bladder cancer
Who may be able to join
- patients with muscle invasive bladder cancer ≥ cT2N0/xM0 who underwent salvage cystectomy / going for bladder preservation protocol.
- patients with muscle invasive bladder cancer underwent radical cystectomy.
Who cannot join
- Patients refusing to participate in our study.
- patients with metastatic bladder cancer
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university hospital
Asyut, Asyut Governorate, 71511
Mohamed Salah, mohamedsalah003@gmail.com
About this study
Official title: Salvage Cystectomy vs Radical Cystectomy, a Comparative Study
To compare operative difficulties, type of urinary diversion, intraoperative \& postoperative complications and quality of life in patients underwent radical cystectomy and those after salvage cystectomy.
Read the detailed description
Radical cystectomy is the standard treatment for muscle-invasive bladder cancer. However, in well selected patients, bladder preservation with radiotherapy and chemotherapy with maximal transurethral resection of bladder tumor (TURBT) is done. Nowadays, multiple guidelines support the use of bladder sparing therapy (BST) in the form of a trimodal therapy (TMT) as an alternative to primary RC with curative intent for selected, well-informed and compliant patients, who desire to retain their bladder. Patients usually would prefer a BST, as it is considered tolerable due to its minimal invasiveness with genuinely manageable toxicity. However, a significant proportion of patients may eventually need a salvage radical cystectomy (SV-RC) due to non-response to BST or local recurrence. Salvage cystectomy post-trimodality therapy for intravesical recurrence has an intraoperative and early complication rate comparable to primary cystectomy, Salvage cystectomy post-trimodality therapy is associated with a higher risk of overall and major late complications than primary cystectomy, Irradiated tissue presents technical and surgical challenges, as radiation can lead to an overexpression of cytokines which causes uncontrolled matrix proliferation and fibrosis These post-radiation changes lead to fixation of pelvic organs, making blunt dissection more difficult, as well as causing disruption of surgical landmarks and loss of tissue planes Another consequence of irradiated tissue is that healing is impaired and tissue is weakened, leading to the potential for wound breakdown and fistula formation.
- Conditions
- Urinary Bladder Cancer
- Being tested
- cystectomy
- Keywords
- salvage, radical
- 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.
cystectomyProcedure or surgery
cystectomy either radical or salvage involves removal of urinary bladder together with prostate, seminal vesicles and urethra with lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| salvage cystectomy | patients will undergo salvage cystectomy after failure of bladder preservation protocol Receives: Procedure: cystectomy | |
| radical cystectomy | patients who will undergo radical cystectomy without going through bladder preservation Receives: Procedure: cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative and postoperative complications of salvage and radical cystectomy.
intraoperative blood loss, quality of dissection, intestinal injury.
Measured: up to 1 year (retrospective and prospective case series)
urinary diversion
type of urinary diversion whether continent or incontinent and which type of shunt.
Measured: 3 months
Secondary outcomes (2)
quality of life of patients postoperatively
describing quality of life in patients postoperatively and how they are able to face and adapt to the new changes and requirements postoperatively
Measured: up to 3 years
postoperative erectile function of patients
studying the effect of radical and salvage cystectomy in patients' sexual function.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start30 Jan 2015
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Urinary 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
- Other
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah Abdul Mawgoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115434
- Sponsor's protocol ID
- Salvage and radical cystectomy
- Status last verified
- Aug 2023
- First submitted
- 27 Nov 2022
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moonen LM, Horenblas S, van der Voet JC, Nuyten MJ, Bartelink H. Bladder conservation in selected T1G3 and muscle-invasive T2-T3a bladder carcinoma using combination therapy of surgery and iridium-192 implantation. Br J Urol. 1994 Sep;74(3):322-7. doi: 10.1111/j.1464-410x.1994.tb16620.x.
PubMed 7953264Milowsky MI, Rumble RB, Booth CM, Gilligan T, Eapen LJ, Hauke RJ, Boumansour P, Lee CT. Guideline on Muscle-Invasive and Metastatic Bladder Cancer (European Association of Urology Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement. J Clin Oncol. 2016 Jun 1;34(16):1945-52. doi: 10.1200/JCO.2015.65.9797. Epub 2016 Mar 21.
PubMed 27001593Ploussard G, Daneshmand S, Efstathiou JA, Herr HW, James ND, Rodel CM, Shariat SF, Shipley WU, Sternberg CN, Thalmann GN, Kassouf W. Critical analysis of bladder sparing with trimodal therapy in muscle-invasive bladder cancer: a systematic review. Eur Urol. 2014 Jul;66(1):120-37. doi: 10.1016/j.eururo.2014.02.038. Epub 2014 Feb 26.
PubMed 24613684Rodel C, Grabenbauer GG, Kuhn R, Papadopoulos T, Dunst J, Meyer M, Schrott KM, Sauer R. Combined-modality treatment and selective organ preservation in invasive bladder cancer: long-term results. J Clin Oncol. 2002 Jul 15;20(14):3061-71. doi: 10.1200/JCO.2002.11.027.
PubMed 12118019Pieretti A, Krasnow R, Drumm M, Gusev A, Dahl DM, McGovern F, Blute ML, Shipley WU, Efstathiou JA, Feldman AS, Wszolek MF. Complications and Outcomes of Salvage Cystectomy after Trimodality Therapy. J Urol. 2021 Jul;206(1):29-36. doi: 10.1097/JU.0000000000001696. Epub 2021 Feb 22.
PubMed 33617327Herskind C, Bentzen SM, Overgaard J, Overgaard M, Bamberg M, Rodemann HP. Differentiation state of skin fibroblast cultures versus risk of subcutaneous fibrosis after radiotherapy. Radiother Oncol. 1998 Jun;47(3):263-9. doi: 10.1016/s0167-8140(98)00018-8.
PubMed 9681889
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage Cystectomy vs Radical Cystectomy, a Comparative Study
- ClinicalTrials.gov ID
- NCT06115434
- Acronym / sponsor ID
- Salvage and radical cystectomy
- Conditions
- Urinary Bladder Cancer
- Keywords
- salvage, radical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jan 2015 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Nov 2023 (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.
To compare operative difficulties, type of urinary diversion, intraoperative \& postoperative complications and quality of life in patients underwent radical cystectomy and those after salvage cystectomy.
Detailed description
Radical cystectomy is the standard treatment for muscle-invasive bladder cancer. However, in well selected patients, bladder preservation with radiotherapy and chemotherapy with maximal transurethral resection of bladder tumor (TURBT) is done. Nowadays, multiple guidelines support the use of bladder sparing therapy (BST) in the form of a trimodal therapy (TMT) as an alternative to primary RC with curative intent for selected, well-informed and compliant patients, who desire to retain their bladder. Patients usually would prefer a BST, as it is considered tolerable due to its minimal invasiveness with genuinely manageable toxicity. However, a significant proportion of patients may eventually need a salvage radical cystectomy (SV-RC) due to non-response to BST or local recurrence. Salvage cystectomy post-trimodality therapy for intravesical recurrence has an intraoperative and early complication rate comparable to primary cystectomy, Salvage cystectomy post-trimodality therapy is associated with a higher risk of overall and major late complications than primary cystectomy, Irradiated tissue presents technical and surgical challenges, as radiation can lead to an overexpression of cytokines which causes uncontrolled matrix proliferation and fibrosis These post-radiation changes lead to fixation of pelvic organs, making blunt dissection more difficult, as well as causing disruption of surgical landmarks and loss of tissue planes Another consequence of irradiated tissue is that healing is impaired and tissue is weakened, leading to the potential for wound breakdown and fistula formation.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| salvage cystectomy | – | Procedure: cystectomypatients will undergo salvage cystectomy after failure of bladder preservation protocol |
| radical cystectomy | – | Procedure: cystectomypatients who will undergo radical cystectomy without going through bladder preservation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with muscle invasive bladder cancer
Key inclusion criteria (2 listed)
- patients with muscle invasive bladder cancer ≥ cT2N0/xM0 who underwent salvage cystectomy / going for bladder preservation protocol.
- patients with muscle invasive bladder cancer underwent radical cystectomy.
Key exclusion criteria (2 listed)
- Patients refusing to participate in our study.
- patients with metastatic bladder cancer
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 |
|---|---|---|
| cystectomycystectomy either radical or salvage involves removal of urinary bladder together with prostate, seminal vesicles and urethra with lymph node dissection. | Procedure or surgery | radical cystectomy, salvage cystectomy |
Primary outcome
intraoperative and postoperative complications of salvage and radical cystectomy.
Time frame: up to 1 year (retrospective and prospective case series)
intraoperative blood loss, quality of dissection, intestinal injury.
urinary diversion
Time frame: 3 months
type of urinary diversion whether continent or incontinent and which type of shunt.
2 secondary outcomes
quality of life of patients postoperatively
Time frame: up to 3 years
postoperative erectile function of patients
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Results publication: PubMed 7953264Moonen LM, Horenblas S, van der Voet JC, Nuyten MJ, Bartelink H. Bladder conservation in selected T1G3 and muscle-invasive T2-T3a bladder carcinoma using combination therapy of surgery and iridium-192 implantation. Br J Urol. 1994 Sep;74(3):322-7. doi: 10.1111/j.1464-410x.1994.tb16620.x.
- Results publication: PubMed 27001593Milowsky MI, Rumble RB, Booth CM, Gilligan T, Eapen LJ, Hauke RJ, Boumansour P, Lee CT. Guideline on Muscle-Invasive and Metastatic Bladder Cancer (European Association of Urology Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement. J Clin Oncol. 2016 Jun 1;34(16):1945-52. doi: 10.1200/JCO.2015.65.9797. Epub 2016 Mar 21.
- Results publication: PubMed 24613684Ploussard G, Daneshmand S, Efstathiou JA, Herr HW, James ND, Rodel CM, Shariat SF, Shipley WU, Sternberg CN, Thalmann GN, Kassouf W. Critical analysis of bladder sparing with trimodal therapy in muscle-invasive bladder cancer: a systematic review. Eur Urol. 2014 Jul;66(1):120-37. doi: 10.1016/j.eururo.2014.02.038. Epub 2014 Feb 26.
- Results publication: PubMed 12118019Rodel C, Grabenbauer GG, Kuhn R, Papadopoulos T, Dunst J, Meyer M, Schrott KM, Sauer R. Combined-modality treatment and selective organ preservation in invasive bladder cancer: long-term results. J Clin Oncol. 2002 Jul 15;20(14):3061-71. doi: 10.1200/JCO.2002.11.027.
- Results publication: PubMed 33617327Pieretti A, Krasnow R, Drumm M, Gusev A, Dahl DM, McGovern F, Blute ML, Shipley WU, Efstathiou JA, Feldman AS, Wszolek MF. Complications and Outcomes of Salvage Cystectomy after Trimodality Therapy. J Urol. 2021 Jul;206(1):29-36. doi: 10.1097/JU.0000000000001696. Epub 2021 Feb 22.
- Results publication: PubMed 9681889Herskind C, Bentzen SM, Overgaard J, Overgaard M, Bamberg M, Rodemann HP. Differentiation state of skin fibroblast cultures versus risk of subcutaneous fibrosis after radiotherapy. Radiother Oncol. 1998 Jun;47(3):263-9. doi: 10.1016/s0167-8140(98)00018-8.
- Individual participant dataSharing planned: No
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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.
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 Urinary 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 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 3 Nov 2023. 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 Mohamed AbdulMawgoud, MBBCH (1011486957 ext. +20, mohamedsalah003@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative and postoperative complications of salvage and radical cystectomy. (time frame: up to 1 year (retrospective and prospective case series)). The study lists 2 primary outcomes in all. 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 NCT06115434, which also lists 6 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 3 Nov 2023.