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Comparing Operative, Postoperative and Quality of Life of Patients After Salvage and Radical Cystectomy

Salvage Cystectomy vs Radical Cystectomy, a Comparative Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06115434
Enrollment
80
Registered
2023-11-03
Start date
2015-01-30
Completion date
2024-12-31
Last updated
2023-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder Cancer

Keywords

salvage, radical

Brief 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.

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.

Interventions

PROCEDUREcystectomy

cystectomy either radical or salvage involves removal of urinary bladder together with prostate, seminal vesicles and urethra with lymph node dissection.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Patients refusing to participate in our study. * patients with metastatic bladder cancer

Design outcomes

Primary

MeasureTime frameDescription
intraoperative and postoperative complications of salvage and radical cystectomy.up to 1 year (retrospective and prospective case series)intraoperative blood loss, quality of dissection, intestinal injury.
urinary diversion3 monthstype of urinary diversion whether continent or incontinent and which type of shunt.

Secondary

MeasureTime frameDescription
quality of life of patients postoperativelyup to 3 yearsdescribing quality of life in patients postoperatively and how they are able to face and adapt to the new changes and requirements postoperatively
postoperative erectile function of patientsup to 2 yearsstudying the effect of radical and salvage cystectomy in patients' sexual function.

Countries

Egypt

Contacts

Primary ContactMohamed AbdulMawgoud, MBBCH
mohamedsalah003@gmail.com1011486957
Backup ContactMohamed Ahmed Abdelrahman, MD
www.mas.1990@gmail.com1117858233

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026