Clinical trial · Interventional
Robotic-assisted vs. Open Partial Nephrectomy
ROBOtic-assisted Versus Conventional Open Partial Nephrectomy: a Single-center, Open-label, Randomized Controlled Feasibility Trial
NCT04534998CI-TRIAL-00053849ROBOCOPunknownPhase 2ClinicalTrials.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)
ROBOCOP is an open-label, randomized controlled feasibility trial comparing robotic-assisted and open partial nephrectomy in preparation for a confirmative phase III randomized controlled trial.
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 |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Partial nephrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robotic-assisted partial nephrectomy
- description
- Partial nephrectomy will be performed using a robotic-assisted laparoscopic approach.
- interventionNames
- Procedure: Partial nephrectomy
- type
- ACTIVE_COMPARATOR
- label
- Open partial nephrectomy
- description
- Partial nephrectomy will be performed using an open retroperitoneal approach.
- interventionNames
- Procedure: Partial nephrectomy
Primary outcomes (1)
- measure
- Recruitment rate
- timeFrame
- 15 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * scheduled for elective partial nephrectomy for renal neoplasms * Patient must be at least 18 years old and capable to consent * abdominal MRI or CT scan * curative-intent surgery * robotic-assisted and open approach for surgery are both feasible * ability of patient to understand the goal, consequences and alternatives of participation in the trial * written informed consent Exclusion Criteria: * patients with solitary kidney * multiple kidney tumors * emergency intervention, for example because of bleeding or perforation * 2nd malignancy that will make PN needless, this does not include secondary malignancies which are under curative treatment or cases in which death from RCC is more likely * patient belongs to a vulnerable patient group * simultaneous 2nd surgery
References
Publications (2)
- DERIVEDKowalewski KF, Neuberger M, Sidoti Abate MA, Kirchner M, Haney CM, Siegel F, Westhoff N, Michel MS, Honeck P, Nuhn P, Kriegmair MC. Randomized Controlled Feasibility Trial of Robot-assisted Versus Conventional Open Partial Nephrectomy: The ROBOCOP II Study. Eur Urol Oncol. 2024 Feb;7(1):91-97. doi: 10.1016/j.euo.2023.05.011. Epub 2023 Jun 12. PMID 37316398
- DERIVEDKowalewski KF, Sidoti Abate MA, Neuberger M, Kirchner M, Krisam R, Egen L, Haney CM, Siegel F, Michel MS, Honeck P, Nuhn P, Westhoff N, Kriegmair MC. ROBOCOP II (ROBOtic assisted versus conventional open partial nephrectomy) randomised, controlled feasibility trial: clinical trial protocol. BMJ Open. 2021 Nov 3;11(11):e052087. doi: 10.1136/bmjopen-2021-052087. PMID 34732486