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Due to low enrollment the study was terminated
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To demonstrate that Robotic-Assisted partial nephrectomy is superior to Open partial nephrectomy in reducing the number of 30 day post-operative complications (Clavien-Dindo Type I-V) for patients with intermediate to high complexity kidney tumors.
Partial nephrectomy is the surgical removal of a kidney tumor while unaffected tissue remains intact so that the kidney function is maintained as far as possible. The more radical procedure would be the complete removal of the kidney, which is not examined in this trial.
Surgery will be randomized either to an open technique involving a large incision or the robotic assisted technique with a few small incisions (keyhole surgery). With robotic assisted surgery the movements of the surgeon are translated into the movement of the instruments.
It is not clear which of the two procedures, open or robotic assisted, has less complications. It is expected that these are different due to the different level of invasiveness and the level of direct access to the organ. This study aims to show that robotic assisted surgery results in less complications than open surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-assisted partial nephrectomy | Active Comparator | da Vinci surgical robotic assisted partial nephrectomy |
|
| Open partial nephrectomy | Active Comparator | Open partial nephrectomy surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted partial nephrectomy | Device | Application of the da Vinci surgical robot to assist the partial nephrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30 day complications | Any complication that occurred within 30 days post surgery | Day of surgery to 30th post operative day |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Timing of surgical steps in the OR | Day of surgery |
| Ischemia time | Period in which the kidney has no blood supply | Day of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc O Grimm, MD, Prof | Department of Urology, University Hospital Jena | Principal Investigator |
| Arnulf Stenzl, MD, Prof | Dept. of Urology, University Hospital Tübingen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Urology, University Hospital Tübingen | Tübingen | Germany | 72076 | Germany | ||
| Department of Urology, University Hospital Düsseldorf |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40250528 | Result | Grimm MO, Bedke J, Nyarangi-Dix J, Khoder W, Foller S, Sommerfeld HJ, Giessing M, Heck M, Meissner W, Slee A, Leucht K, von Rundstedt F, Theil G, Buse S, Siemer S, Albers P, Gratzke C, Hohenfellner M, Stenzl A. Open versus robotic-assisted partial nephrectomy in patients with intermediate/high-complexity kidney tumours: final results of the randomised, controlled, open-label, multicentre trial OpeRa. Ann Oncol. 2025 Aug;36(8):988-998. doi: 10.1016/j.annonc.2025.04.005. Epub 2025 Apr 16. |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D061887 | Conversion to Open Surgery |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Open partial nephrectomy | Other | Open surgery to conduct the partial nephrectomy |
|
|
| Surgical radicality conversions | Conversion from robotic to open, partial to radical | Day of surgery |
| Intraoperative blood loss | Volume of blood loss during the surgical procedure | Day of surgery |
| Pain assessment | Assessment of pain level via the Brief Pain Inventory (BPI) | Baseline until Day 90 |
| Pain Medication | Recording pain medication | Baseline until Day 90 |
| Neuropathic pain | Development of neuropathic pain via the DN-4 Patient interview questions | Baseline and Day 30 and Day 90 |
| Kidney function via the estimated glomerular filtration rate (eGRF) | Data will be gathered from routine examination, not a mandatory assessment | Baseline until Day 5 / discharge (whatever is earlier) |
| Post operative complications | Any Clavien-Dindo I-V post-operative complication | Day 90 |
| Length of stay | Time from surgery to discharge | Discharge |
| Procedure related readmissions | Readmission that can be linked to the partial nephrectomy | Day 90 |
| Procedure related reoperations | Re-operation that can be linked to the partial nephrectomy | Day 90 |
| Quality of recovery from the intervention | Quality of recovery questionnaire QoR-9 | Baseline until Day 5 / discharge (whatever is earlier) |
| Quality of life questionnaire, generic measure | EQ-5D 5L | Baseline until Day 90 |
| Quality of life questionnaire, cancer patient specific | EORTC QLQ-C30 | Baseline until Day 90 |
| Overall survival | time from surgery to death from any cause | Day of surgery to 5 years |
| Disease specific survival | time from surgery to death due to kidney cancer | Day of surgery to 5 years |
| Disease free survival | time from surgery to first documented recurrence of renal cell carcinoma as defined by the investigator | Day of surgery to 5 years |
| Local recurrence free survival | Time from surgery to the first documented local recurrence e.g. tumor in the operated kidney or in the immediate vicinity (e.g. perirenal fat) at the surgical site. Portside recurrence / incisional, surgical access site recurrence to the affected kidney would also be considered as a local recurrence. | Day of surgery to 5 years |
| Comprehensive Complication Index | Any complication that occurred within 30 days post surgery | Day of surgery to 30th post operative day |
| Düsseldorf |
| 40225 |
| Germany |
| Department of Urology, Alfried Krupp Krankenhaus Rüttenscheid | Essen | 45131 | Germany |
| Department of Urology, University Hospital Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitätsklinik und Poliklinik für Urologie | Halle | 06120 | Germany |
| Universitätsklinikum Heidelberg, Urologische Klinik | Heidelberg | 69120 | Germany |
| Klinik für Urologie, Marien Hospital Herne | Herne | 44625 | Germany |
| Department of Urology - Universitätsklinikum des Saarlandes | Homburg | 66421 | Germany |
| Department of Urology, University Hospital Jena | Jena | 07747 | Germany |
| Klinik für Urologie, Marien-Hospital Marl | Marl | 45768 | Germany |
| Department of Urology, Klinikum rechts der Isar der Technischen Universität | Munich | 81675 | Germany |
| Helios Universitätsklinkum Wuppertal - Department of Urology | Wuppertal | 42283 | Germany |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |