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

A

Assiut University

Status

Enrolling

Conditions

Urinary Bladder Cancer

Treatments

Procedure: cystectomy

Study type

Observational

Funder types

Other

Identifiers

NCT06115434
Salvage and radical cystectomy

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

salvage cystectomy
Description:
patients will undergo salvage cystectomy after failure of bladder preservation protocol
Treatment:
Procedure: cystectomy
radical cystectomy
Description:
patients who will undergo radical cystectomy without going through bladder preservation
Treatment:
Procedure: cystectomy

Trial contacts and locations

1

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Central trial contact

Mohamed Ahmed Abdelrahman, MD; Mohamed AbdulMawgoud, MBBCH

Data sourced from clinicaltrials.gov

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