Clinical trial NCT06115434: Comparing Operative, Postoperative and Quality of Life of Patients After Salvage and Radical Cystectomy
Official title: Salvage Cystectomy vs Radical Cystectomy, a Comparative Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Bladder Cancer
Keywords: salvage
radical
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with muscle invasive bladder cancer

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.

Eligibility criteria: 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

Primary outcomes:
measure: intraoperative and postoperative complications of salvage and radical cystectomy.
timeFrame: up to 1 year (retrospective and prospective case series)
measure: urinary diversion
timeFrame: 3 months
Secondary outcomes:
measure: quality of life of patients postoperatively
timeFrame: up to 3 years
measure: postoperative erectile function of patients
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
state: أسيوط
Study officials:
References:
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