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

Recruiting

• Conditions: Urinary Bladder Cancer
• Interventions: Procedure: cystectomy

• Registration Number: NCT06115434
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2015-01-30
• Study First Submitted: 2022-11-27
• Status Verified: 2023-08
• Study First Submitted QC: 2023-10-29
• Last Update Submitted: 2023-10-29
• Study First Posted: 2023-11-03
• Last Update Posted: 2023-11-03
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
salvage cystectomy	cystectomy	patients will undergo salvage cystectomy after failure of bladder preservation protocol
radical cystectomy	cystectomy	patients who will undergo radical cystectomy without going through bladder preservation

Primary Outcome Measures

Name	Time	Method
urinary diversion	3 months	type of urinary diversion whether continent or incontinent and which type of shunt.
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.

Secondary Outcome Measures

Name	Time	Method
postoperative erectile function of patients	up to 2 years	studying the effect of radical and salvage cystectomy in patients' sexual function.
quality of life of patients postoperatively	up to 3 years	describing quality of life in patients postoperatively and how they are able to face and adapt to the new changes and requirements postoperatively

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, أسيوط, Egypt