Randomized controlled feasibility trial of robot-assisted Versus conventional open partial nephrectomy

• Verfasst von: Kowalewski, Karl-Friedrich [VerfasserIn]
• Verfasst von: Neuberger, Manuel [VerfasserIn]
• Verfasst von: Sidoti Abate, Marie Angela [VerfasserIn]
• Verfasst von: Kirchner, Marietta [VerfasserIn]
• Verfasst von: Haney, Caelan Max [VerfasserIn]
• Verfasst von: Siegel, Fabian [VerfasserIn]
• Verfasst von: Westhoff, Niklas Christian [VerfasserIn]
• Verfasst von: Michel, Maurice Stephan [VerfasserIn]
• Verfasst von: Honeck, Patrick [VerfasserIn]
• Verfasst von: Nuhn, Philipp [VerfasserIn]
• Verfasst von: Kriegmair, Maximilian [VerfasserIn]
• Titel: Randomized controlled feasibility trial of robot-assisted Versus conventional open partial nephrectomy
• Titelzusatz: the ROBOCOP II study
• Verf.angabe: 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
• E-Jahr: 2024
• Jahr: February 2024
• Umfang: 7 S.
• Illustrationen: Illustrationen
• Fussnoten: Online verfügbar: 12. Juni 2023, Artikelversion: 28. Januar 2024 ; Gesehen am 12.04.2024
• Titel Quelle: Enthalten in: European urology oncology
• Ort Quelle: Amsterdam : Elsevier, 2018
• Jahr Quelle: 2024
• Band/Heft Quelle: 7(2024), 1 vom: Feb., Seite 91-97
• ISSN Quelle: 2588-9311
• DOI: doi:10.1016/j.euo.2023.05.011
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: Evidence-based medicine
• Sach-SW: Kidney cancer
• Sach-SW: Partial nephrectomy
• Sach-SW: Randomized controlled trial
• Sach-SW: Robotic surgery
• K10plus-PPN: 1895238749

Abstract

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.