Trial to Compare Robotically Assisted Radical Cystectomy With Open Radical Cystectomy

Study Overview
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Brief Summary
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This is a prospective multicentre randomised controlled trial comparing the outcomes from Intracorporeal RARC (iRARC) with open radical cystectomy (ORC) in patients with bladder cancer. The study will recruit patients with non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancer (MIBC) who have selected radical cystectomy for the treatment of bladder cancer. The time of interest for measurement of the primary outcomes will be 90 days post-surgery. Eligible patients will include those receiving neo-adjuvant chemotherapy (typically gemcitabine and cisplatin) and those having either an ileal conduit or a neo-bladder reconstruction. Patients who have selected radical cystectomy after appropriate counselling and following a specialist multi-disciplinary team (SMDT) recommendation, will be approached and asked to consent for this study. Consenting participants will be randomised 1:1 to either iRARC or ORC. Patients will be followed for a minimum of 90 days post-surgery. The study will be conducted in National Health Service (NHS) Trusts designated as Cancer Centres. Patients will be stratified by Type of urinary diversion (Continent diversion or ileal conduit) Performance status Centre Trial assessments will be conducted at baseline (before surgery), whilst participants are on admission and then 5, 12, 26 weeks,1 year and 18 months post surgery.

Detailed Description
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Radical cystectomy (RC) represents the gold standard treatment for invasive bladder cancer. Reductions in morbidity and mortality from this operation have occurred in recent years through refined anaesthesia, surgical techniques, and centralization of services in high volume centres. The multimodal concept of enhanced recovery after RC (ERAS), which includes pre, intra and post operative steps, has also helped to reduce the length of stay and complications after RC further. For most abdominal surgery, it is recognized that minimally invasive surgery is less morbid than open surgery, and produces improvements in post-operative recovery without altering the curative nature of the procedure. However, to date, there is little or conflicting evidence of any benefit from minimally invasive surgery over open surgery for RC. This may reflect the complex nature of this procedure (involving surgery to both the urinary and gastro-intestinal tracts), limitations of the current evidence or that there is no benefit. To date, three prospective trials have compared RARC with open RC (ORC). However, each has been limited by sample size and design, or their application of RARC with extra-corporeal reconstruction or have yet to report. The investigators believe that there are no studies (reported or planned) that have compared optimal RARC (e.g. with intra-corporeal reconstruction) with optimal ORC (e.g. high volume centre using ERAS). In addition, the investigators believe none have adequately assessed the rehabilitation from RC. As such, the investigators now propose a prospective RCT to randomize eligible patients to either ORC or RARC. The investigators will focus upon measures of functional recovery and the return to normal activities.

Official Title
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A Phase III Multicentre Randomised Controlled Trial to Compare the Efficacy of Robotically Assisted Radical Cystectomy (RARC) and Intracorporeal Urinary Diversion With Open Radical Cystectomy (ORC) in Patients With Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: Intracorporeal Robot Assisted Radical Cystectomy
* Procedure: Open Radical Cystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be over 18 years of age. Male or female Histopathological confirmation of bladder cancer (UCC, SCC, adenocarcinoma or rare variant) CIS or stage pTa or pT1 or ≥pT2 or mobile bladder mass on bimanual examination under anaesthesia (see Section 22: Definitions for TNM definitions) Node status ≤ N1 on imaging criteria or PET -ve outside pelvis ECOG grade 0, 1, 2 or 3 Able to give informed written consent to participate. Exclusion Criteria: Unwilling to undergo cystectomy. Previous abdominal surgery rendering them unsuitable for either iRARC or ORC. Patients with upper urinary tract disease Concomitant disease that would render the patient unsuitable for the trial Pregnant or lactating females Previous radiotherapy for bladder cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iRARC<br>Intracorporeal Robot Assisted Radical Cystectomy | Procedure: Intracorporeal Robot Assisted Radical Cystectomy<br>* Intracorporeal robot assisted radical cystoprostatectomy or anterior exenteration<br>|
| Active Comparator: Open Radical Cystectomy (ORC)<br>Open Radical Cystectomy | Procedure: Open Radical Cystectomy<br>* Removal of bladder and adjacent organs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days at home within 90 days of the surgery | To compare the number of days alive and out of hospital within 90 days from surgery. | 90 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulties due to health conditions measured using WHODAS version 2.0 | To assess recovery and complications and the return to normal activities. | 12 months post surgery | 
| Quality of Life measured using EQ-5D-5L Health Questionnaire and EORTC QLQ-C30 version 3. | To assess recovery and complications and the return to normal activities. | 12 months post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystectomy