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

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06115434
Collaborator
(none)
80
1
119
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
80 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Salvage Cystectomy vs Radical Cystectomy, a Comparative Study
Actual Study Start Date :
Jan 30, 2015
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
salvage cystectomy

patients will undergo salvage cystectomy after failure of bladder preservation protocol

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

radical cystectomy

patients who will undergo radical cystectomy without going through bladder preservation

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. urinary diversion [3 months]

    type of urinary diversion whether continent or incontinent and which type of shunt.

Secondary Outcome Measures

  1. 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

  2. postoperative erectile function of patients [up to 2 years]

    studying the effect of radical and salvage cystectomy in patients' sexual function.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut university hospital Assiut أسيوط Egypt 71511

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Salah Abdul Mawgoud, principal ivestigator, urology resident, Assiut University
ClinicalTrials.gov Identifier:
NCT06115434
Other Study ID Numbers:
  • Salvage and radical cystectomy
First Posted:
Nov 3, 2023
Last Update Posted:
Nov 3, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Salah Abdul Mawgoud, principal ivestigator, urology resident, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2023