Randomized controlled feasibility trial of robot-assisted Versus conventional open partial nephrectomy: the ROBOCOP II study
Background - There is no evidence from randomized controlled trials (RCTs) comparing robot-assisted partial nephrectomy (RAPN) and open partial nephrectomy (OPN). - Objective - To assess the feasibility of trial recruitment and to compare surgical outcomes between RAPN and OPN. - Design, setting, an...
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| Main Authors: | , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
February 2024
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| In: |
European urology oncology
Year: 2024, Volume: 7, Issue: 1, Pages: 91-97 |
| ISSN: | 2588-9311 |
| DOI: | 10.1016/j.euo.2023.05.011 |
| Online Access: | Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.euo.2023.05.011 Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S2588931123001128 
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| Author Notes: | Karl-Friedrich Kowalewski, Manuel Neuberger, Marie Angela Sidoti Abate, Marietta Kirchner, Caelan Max Haney, Fabian Siegel, Niklas Westhoff, Maurice-Stephan Michel, Patrick Honeck, Philipp Nuhn, Maximilian Christian Kriegmair |
| Summary: | Background - There is no evidence from randomized controlled trials (RCTs) comparing robot-assisted partial nephrectomy (RAPN) and open partial nephrectomy (OPN). - Objective - To assess the feasibility of trial recruitment and to compare surgical outcomes between RAPN and OPN. - Design, setting, and participants - ROBOCOP II was designed as single-center, open-label, feasibility RCT. Patients with suspected localized renal cell carcinoma referred for PN were randomized at a 1:1 ratio to either RAPN or OPN. - Outcome measurements and statistical analysis - The primary outcome was the feasibility of recruitment, assessed as the accrual rate. Secondary outcomes included perioperative and postoperative data. Data were analyzed descriptively in a modified intention-to-treat population consisting of randomized patients who underwent surgery. - Results and limitations - A total of 50 patients underwent RAPN or OPN (accrual rate 65%). In comparison to OPN, RAPN had lower blood loss (OPN 361 ml, standard deviation [SD] 238; RAPN 149 ml, SD 122; difference 212 ml, 95% confidence interval [CI] 105-320; p < 0.001), less need for opioids (OPN 46%; RAPN 16%; difference 30%, 95% CI 5-54; p = 0.024), and fewer complications according to the mean Comprehensive Complication Index (OPN 14, SD 16; RAPN 5, SD 15; difference 9, 95% CI 0-18; p = 0.008). OPN has a shorter operative time (OPN 112 min, SD 29; RAPN 130 min, SD 32; difference −18 min, 95% CI −35 to −1; p = 0.046) and warm ischemia time (OPN 8.7 min, SD 7.1; RAPN 15.4 min, SD 7.0; difference 6.7 min, 95% CI −10.7 to −2.7; p = 0.001). There were no differences between RAPN and OPN regarding postoperative kidney function. - Conclusions - This first RCT comparing OPN and RAPN met the primary outcome of the feasibility of recruitment; however, the window for future RCTs is closing. Each approach has advantages over the other, and both remain safe and effective options. - Patient summary - For patients with a kidney tumor, open surgery and robot-assisted keyhole surgery are both feasible and safe approaches for partial removal of the affected kidney. Each approach has known advantages. Long-term follow-up will explore differences in quality of life and cancer control outcomes. |
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| Item Description: | Online verfügbar: 12. Juni 2023, Artikelversion: 28. Januar 2024 Gesehen am 12.04.2024 |
| Physical Description: | Online Resource |
| ISSN: | 2588-9311 |
| DOI: | 10.1016/j.euo.2023.05.011 |