Clinical Trials Directory

Trials / Unknown

UnknownNCT06115434

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

Salvage Cystectomy vs Radical Cystectomy, a Comparative Study

Status
Unknown
Phase
Study type
Observational
Enrollment
80 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2015-01-30
Primary completion
2024-12-01
Completion
2024-12-31
First posted
2023-11-03
Last updated
2023-11-03

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06115434. Inclusion in this directory is not an endorsement.