Standard open radical cystectomy (ORC) versus robotically assisted radical cystectomy (RARC)

Not Applicable

Completed

• Conditions: Bladder cancer; Cancer; Malignant neoplasm of bladder

• Registration Number: ISRCTN13680280
• Lead Sponsor: niversity College London

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30093510 protocol (added 23/10/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35569079/ (added 16/05/2022)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-25
• Study Completion: 2021-09-30
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

Current inclusion criteria as of 04/07/2017:
1. Participants must be over 18 years of age
2. Male or female
3. Histopathological confirmation of bladder cancer (UCC, SCC, adenocarcinoma or rare variant)
4. CIS or stage pTa or pT1 or =pT2 or mobile bladder mass on bimanual examination under anaesthesia
5. Node status = N1 on imaging criteria or PET –ve outside pelvis
6. ECOG grade 0, 1, 2 or 3
7. Able to give informed written consent to participate

Previous inclusion criteria:
1. Participants must be over 18 years of age
2. Male or female
3. Histopathological confirmation of bladder cancer (UCC, SCC, adenocarcinoma or rare variant)
4. CIS or stage pTa or pT1 or =pT2 or mobile bladder mass on bimanual examination under anaesthesia
5. Node status = N1 on imaging criteria or PET –ve outside pelvis
6. ASA grade 1,2,3 or 4
7. Able to give informed written consent to participate

Exclusion Criteria

Current exclusion criteria as of 04/07/2017:
1. Unwilling to undergo cystectomy
2. Previous abdominal surgery rendering them unsuitable for either iRARC or ORC
3. Patients with upper urinary tract disease
4. Concomitant disease that would render the patient unsuitable for the trial
5. Pregnant or lactating females
6. Previous radiotherapy for bladder cancer

Previous exclusion criteria:
1. Unwilling to undergo cystectomy
2. Previous abdominal surgery other than hernia repair or cholecystectomy
3. Patients with upper urinary tract disease
4. Concomitant disease that would render the patient unsuitable for the trial
5. Pregnant or lactating females

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of days alive and out of hospital within 90 days from surgery is assessed by reviewing patient’s medical notes and conducting follow-up visits at 5 weeks and 12 weeks after surgery.

Secondary Outcome Measures

Name	Time	Method
1. Self-administered WHODAS-2 (12 point) questionnaire at baseline (pre-operative), 5 weeks, 12 weeks, 24 weeks and 1 year after surgery<br>2. Self-administered EORTC QLQ-BLM30 questionnaire at baseline (pre-operative), 5 weeks, 12 weeks, 24 weeks and 1 year after surgery<br>3. Self-administered EQ-5D-5L questionnaire at baseline, 5 weeks, 12 weeks, 24 weeks and 1 year after surgery<br>4. Quantified activity levels: Total steps taken over 7 consecutive days (measured using a wearable tracking device e.g. Fitbit) at baseline (pre-operative), 5 days post-op, 5 weeks, 12 weeks, 24 weeks and 1 year after surgery<br>5. 30 Second Chair to Stand test: Number of times the patient can stand from sitting in a 30 second interval. This will be conducted in clinic at baseline (pre-operative), 5 weeks, 12 weeks, 24 weeks and 1 year after surgery<br><br>The following tools will be used to measure complications:<br>Adverse events recorded using the Clavien-Dindo classification.