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

Study Overview
=================
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.

Official Title
-----------------
Salvage Cystectomy vs Radical Cystectomy, a Comparative Study

Conditions
-----------------
Urinary Bladder Cancer

Intervention / Treatment
-----------------
* Procedure: cystectomy


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| salvage cystectomy<br>patients will undergo salvage cystectomy after failure of bladder preservation protocol | Procedure: cystectomy<br>* cystectomy either radical or salvage involves removal of urinary bladder together with prostate, seminal vesicles and urethra with lymph node dissection.<br>|
| radical cystectomy<br>patients who will undergo radical cystectomy without going through bladder preservation | Procedure: cystectomy<br>* cystectomy either radical or salvage involves removal of urinary bladder together with prostate, seminal vesicles and urethra with lymph node dissection.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative and postoperative complications of salvage and radical cystectomy. | intraoperative blood loss, quality of dissection, intestinal injury. | up to 1 year (retrospective and prospective case series) | 
| urinary diversion | type of urinary diversion whether continent or incontinent and which type of shunt. | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
salvage, radical