Clinical trial · Interventional
Study Comparing Open Radical Cystectomy With Robot-assisted Cystectomy in Patients With Bladder Cancer
A Controlled Blinded Randomized Feasibility Study of Open Radical Cystectomy (ORC) Versus Robot-Assisted Radical Cystectomy With Intracorporal Urinary Diversion (iRARC) Under an Enhanced Recovery After Surgery (ERAS) Setup
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study to compare two established methods of radical cystectomy (RC) in patients with bladder cancer. The participants will be treated under conditions in alignment with up-to-date guidelines and care. We wish to investigate whether it is feasible to compare the two methods under conditions of the highest methodological quality.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical Cystectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Open Radical Cystectomy (ORC)
- description
- Open radical cystectomy includes in both genders removal of the bladder and distal ureters as well as pelvic lymphadenectomy. In men the procedure includes removal of the prostate and seminal vesicles and in women removal of the uterus, ovaries, urethra and part of the vagina. Lastly, for both genders an iliac conduit urinary diversion is performed.
- interventionNames
- Procedure: Radical Cystectomy
- type
- ACTIVE_COMPARATOR
- label
- Robot-assisted Radical Cystectomy (iRARC)
- description
- Robot-assisted radical cystectomy includes in both genders removal of the bladder and distal ureters as well as pelvic lymphadenectomy. In men the procedure includes removal of the prostate and seminal vesicles and in women removal of the uterus, ovaries, urethra and part of the vagina. Lastly, for both genders an intracorporeal iliac conduit urinary diversion is performed.
- interventionNames
- Procedure: Radical Cystectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age\> 18 * non-metastatic disease * fit for both ORC and RARC * Patient-selected urinary diversion: ileal conduit Exclusion Criteria: * if not able to speak/understand Danish * not able to cooperate for fully informed consent * need for extensive concomitant surgery (i.e. nephroureterectomy) * prior down staging chemotherapy (prior neoadjuvant chemotherapy accepted) * prior radiation therapy * prior major extensive abdominal or pelvic surgery * prior peritonitis * conditions contraindicating extended Trendelenburg's position
References
Publications (1)
- DERIVEDMaibom SL, Joensen UN, Aasvang EK, Rohrsted M, Thind PO, Bagi P, Kistorp T, Poulsen AM, Salling LN, Kehlet H, Brasso K, Roder MA. Robot-assisted laparoscopic radical cystectomy with intracorporeal ileal conduit diversion versus open radical cystectomy with ileal conduit for bladder cancer in an ERAS setup (BORARC): protocol for a single-centre, double-blinded, randomised feasibility study. Pilot Feasibility Stud. 2023 Jan 13;9(1):7. doi: 10.1186/s40814-022-01229-3. PMID 36639814