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Trial Title:
Comparing Operative, Postoperative and Quality of Life of Patients After Salvage and Radical Cystectomy
NCT ID:
NCT06115434
Condition:
Urinary Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
salvage
radical
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Procedure
Intervention name:
cystectomy
Description:
cystectomy either radical or salvage involves removal of urinary bladder together with
prostate, seminal vesicles and urethra with lymph node dissection.
Arm group label:
radical cystectomy
Arm group label:
salvage cystectomy
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.
Criteria for eligibility:
Study pop:
patients with muscle invasive bladder cancer
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Assiut university hospital
Address:
City:
Assiut
Zip:
71511
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Mohamed Salah
Email:
mohamedsalah003@gmail.com
Start date:
January 30, 2015
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06115434
