Clinical trial · Interventional
Randomized Trial Comparing Robotic and Open Radical Cystectomy
A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy
NCT01076387CI-TRIAL-00044026completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 this study is to determine if using robotic surgical technology during bladder cancer surgery helps to reduce complications during and after the surgery. The removal of the bladder and lymph nodes will be done by a robotic or by an open technique. It may be a Robotic-assisted Radical Cystectomy (RARC) and Pelvic Lymph Node Dissection. Or it may be an Open Radical Cystectomy (ORC) and Pelvic Lymph Node Dissection.
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 |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| open radical cystectomy | Procedure | — | UNRESOLVED |
| robotic-assisted radical cystectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- open radical cystectomy
- description
- This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer.
- interventionNames
- Procedure: open radical cystectomy
- type
- ACTIVE_COMPARATOR
- label
- robotic-assisted radical cystectomy
- description
- This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer.
- interventionNames
- Procedure: robotic-assisted radical cystectomy
Primary outcomes (1)
- measure
- To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years. * Scheduled for radical cystectomy at MSKCC Exclusion Criteria: * Prior pelvic or abdominal radiation therapy; * Prior extensive open abdominal surgery, defined by the discretion of the attending surgeon * Any clinical contraindication for Trendelenburg positioning
References
Publications (1)
- DERIVEDBochner BH, Dalbagni G, Sjoberg DD, Silberstein J, Keren Paz GE, Donat SM, Coleman JA, Mathew S, Vickers A, Schnorr GC, Feuerstein MA, Rapkin B, Parra RO, Herr HW, Laudone VP. Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial. Eur Urol. 2015 Jun;67(6):1042-1050. doi: 10.1016/j.eururo.2014.11.043. Epub 2014 Dec 8. PMID 25496767