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| Name | Class |
|---|---|
| Heidelberg University | OTHER |
| Dietmar Hopp Stiftung | OTHER |
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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.
Surgical excision is the gold standard for the treatment for localized kidney cancer. An organ-preserving procedure should be carried out whenever possible in order to maintain kidney function. Partial nephrectomy can be performed through the conventional open technique as well as through a robotic-assisted approach. Although both methods belong to the standard care, there is still no published data from randomized controlled trials in the scientific literature comparing them. The ROBOCOP-trial is designed as a single-center comparison of the two surgical approaches in preparation for a phase III study. 50 patients are to be included in the trial within a period of 15 months. The primary endpoint is feasibility of patient recruitment. In addition, potential primary outcomes for a confirmative trial such as perioperative complications, quality of life, inflammatory response, survival and ergonomic aspects for the operating surgeons will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-assisted partial nephrectomy | Experimental | Partial nephrectomy will be performed using a robotic-assisted laparoscopic approach. |
|
| Open partial nephrectomy | Active Comparator | Partial nephrectomy will be performed using an open retroperitoneal approach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partial nephrectomy | Procedure | Partial nephrectomy for localized kidney cancer as curative treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Proportion of randomized patients in relation to the eligible ones. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative complications | Measured with 1) the comprehensive complication index (CCI), on a scale from 0 (no complications) to 100 (death) and 2) the Clavien-Dindo classification, which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the normal postoperative course, the highest grade indicating death | throughout patient´s hospital stay, on average 6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karl-Friedrich Kowalewski, M.D. | Contact | 00496213832201 | karl-friedrich.kowalewski@umm.de |
| Name | Affiliation | Role |
|---|---|---|
| Maximilian C. Kriegmair, M.D. | Department of Urology, University Medical Center Mannheim, University of Heidelberg | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, University Medical Center Mannheim, University of Heidelberg | Recruiting | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37316398 | Derived | Kowalewski 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. | |
| 34732486 |
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Patient information might be shared after signing a data sharing agreement and IRB approval
After completion of the study (anticipated March 2021)
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| Postoperative complications | Measured with 1) the comprehensive complication index (CCI), on a scale from 0 (no complications) to 100 (death) and 2) the Clavien-Dindo classification, which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the normal postoperative course, the highest grade indicating death | 90 days |
| Self-reported generic health status | Patient-reported generic health status using EQ-5D-5L(EuroQol-5D-5L) questionnaire (the scale ranges from 0 to 100, with 100 representing the highest health status) | 90 days |
| Self-reported quality of life assessment of cancer patients | Cancer patients will be reporting their quality of life making use of the questionnaire QLQ-C30 (Quality of Life Questionnaire C30) (range 0-100, high scores represent a better quality of life) | 90 days |
| Self-reported quality of life in patients with kidney disease | Patients will assess the influence of their kidney disease on everyday activities, work status, social interactions, mental and physical health making use of KDQOL-SF (Kidney Disease Quality of Life Short Form), ranging from 0 ("worst possible health") to 10 ("best possible health") | 90 days |
| Self-assessment of depression in patients ≥ 65 years old | Elderly patients (≥ 65 years old) will report their depression symptoms filling GDS (Geriatric Depression Scale) questionnaire, ranging from 0 to 30, with 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed". | 90 days |
| Self-evaluation of cancer disease´s influence on elderly patients´ life | Elderly patients (≥ 65 years old) will evaluate the influence of their cancer disease on their life (activities of daily living, cognition, mood, nutritional status, mobility, polypharmacy and social support), on a scale ranging from 0 to 17, 17 indicating the best outcome possible on quality of life. | 90 days |
| Self-assessment of comorbidity in elderly patients | Elderly patients (≥ 65 years old) will make use of SCQ (Self-Administered Comorbidity Questionnaire) to assess common comorbidities; a higher score indicates higher comorbidities (range 0-39) | 90 days |
| Postoperative self-reported quality of life | Participants will evaluate their postoperative quality of life on a 0-100 scale, higher scores indicating a better quality of life and return to daily life activities. | 90 days |
| Kidney function - creatinine | postoperative change in kidney function - creatinine (measured in mg/dL) | 90 days |
| Kidney function - GFR | postoperative change in kidney function - glomerular filtration rate (measured in mL/min) | 90 days |
| Length of hospital stay | Total time of hospital stay | throughout patient´s hospital stay, on average 6 days |
| Operative time | Surgery duration | Immediately after surgery |
| Inflammatory response - leucocytes | postoperative course of inflammatory parameters (leucocytes, unit of measure: white cells x10^9/L) | throughout patient´s hospital stay, on average 6 days |
| Inflammatory response - C-reactive protein | postoperative course of inflammatory parameters (c-reactive protein, measured in mg/L) | throughout patient´s hospital stay, on average 6 days |
| Inflammatory response | postoperative course of inflammatory parameters (IL-6, TNF-α, IL-1β, VEGF, measured in ng/L) | throughout patient´s hospital stay, on average 6 days |
| Surgical ergonomics | Surgeons will be asked to evaluate localized muscle pain on a scale from 0 to 10, 10 indicating extreme discomfort | Immediately after surgery |
| Surgical ergonomics | Surgeons will be asked to fill NASA TLX questionnaire (NASA Task Load Index). Range: 0-100, high scores indicate a high task load | During surgery |
| Resection status | Rate of R0/R1 status in each arm | up to 5 days |
| Use of analgesia | Need for pain medications | throughout patient´s hospital stay, on average 6 days |
| Trifecta outcomes of partial nephrectomy | Trifecta is defined as no major complication, R0-resection status and ischemia time of less than 25 minutes | 90 days |
| Blood loss | Blood loss during surgery | Immediately after surgery |
| Conversion to open surgery | Rate of conversion to open surgery | Immediately after surgery |
| Conversion to radical nephrectomy | Rate of conversion to radical nephrectomy | Immediately after surgery |
| Case cost | DRG-related case costs per arm | 90 days |
| Kowalewski 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. |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |