Abstract
Background
Objective
Design, setting, and participants
Outcome measurements and statistical analysis
Results and limitations
Conclusions
Patient summary
Keywords
1. Introduction
2. Patients and methods
2.1 Data source and patient selection
2.2 Research hypotheses and outcomes of interest
- Intra- and post-operative outcomes: intraoperative complications; estimated blood loss (eBL); operative time; postoperative complications, including overall and grade-specific complications according to the Clavien-Dindo (CD) classification [[9]], hemorrhagic events, and urinary leakages; and length of stay
- Functional outcomes: warm ischemia time and postoperative estimated glomerular filtration rate (eGFR), defined according to the Chronic Kidney Disease Epidemiology Collaboration equation for patients aged <70 yr and the Berlin Initiative Study formula for patients aged ≥70 yr [[10]], and measured at the last determination before discharge and 1 yr after surgery
- Pathologic and oncologic outcomes: positive surgical margins, local recurrence (LC; defined as evidence of disease in the resection bed), systemic progression (SP; defined as evidence of disease elsewhere than the treated kidney), and cancer-specific and all-cause mortality; vital status and cause of death were identified from death certificates and physician correspondence
2.3 Covariates
2.4 Statistical analyses
3. Results
3.1 Descriptive characteristics
Variable | RAPN (n = 2404; 69%) | OPN (n = 1063; 31%) | p value |
---|---|---|---|
Age (yr) | 61 (51, 69) | 65 (54, 72) | <0.001 |
Gender, male | 1502 (63) | 690 (65) | 0.1 |
CCI | |||
0 | 845 (35) | 356 (34) | 0.5 |
1 | 416 (17) | 204 (19) | |
2 | 602 (25) | 270 (25) | |
≥3 | 541 (23) | 233 (22) | |
eGFR (ml/min/1.73 m2) | 84 (65, 97) | 80 (62, 94) | <0.001 |
Single kidney | 77 (3) | 52 (5) | 0.02 |
Clinical size (cm) | 3.0 (2.0, 4.2) | 3.2 (2.4, 4.3) | <0.001 |
Clinical stage | |||
cT1a | 1744 (73) | 762 (72) | 0.4 |
cT1b | 563 (23) | 245 (23) | |
cT2 | 98 (4) | 56 (5) | |
Tumor side, left | 1155 (48) | 502 (47) | 0.7 |
PADUA score | 8 (7, 10) | 8 (7, 9) | <0.001 |
PADUA risk class | |||
High | 1039 (43) | 426 (40) | 0.2 |
Medium | 644 (27) | 307 (29) | |
Low | 721 (30) | 330 (31) | |
Year of surgery | |||
2004–2011 | 556 (23) | 596 (56) | <0.001 |
2012–2014 | 745 (31) | 295 (28) | |
2015–2018 | 1103 (46) | 172 (16) | |
Pathologic size (cm) | 3.0 (2.0, 4.1) | 3.0 (2.1, 4.0) | 0.1 |
Malignancy on final pathology | 1920 (80) | 834 (78) | 0.7 |
T3-T4 on final pathology | 107 (4.4) | 51 (4.7) | 0.8 |
G3-G4 on final pathology | 550 (23) | 191 (18) | 0.3 |
Median follow-up for survivors (mo) | 24 (14–47) | 62 (30–100) | 0.001 |
3.2 Comparison between RAPN and OPN
3.2.1 Intra- and postoperative outcomes
Outcome | RAPN (n = 2404) | OPN (n = 1063) | RAPN vs OPN OR/EST/HR (95% CI) | p value |
---|---|---|---|---|
Intraoperative outcomes | ||||
Estimated blood loss (ml) | 150 (100, 300) | 180 (100, 350) | –140 (–163, –115) | <0.001 |
Operative time (min) | 150 (120, 200) | 120 (100, 163) | +31 (+26, +36) | <0.001 |
Intraoperative complications | 139 (6) | 99 (9) | 0.39 (0.22, 0.68) | <0.001 |
Postoperative outcomes and complications | ||||
Overall complications | 435 (18) | 355 (33) | 0.51 (0.33, 0.76) | 0.001 |
Clavien-Dindo complications | ||||
≥2 | 279 (12) | 215 (20) | 0.29 (0.16, 0.50) | <0.001 |
≥3 | 97 (4) | 65 (6) | 0.26 (0.08, 0.65) | 0.008 |
Hemorrhagic complications | 155 (6) | 96 (9) | 0.22 (0.08, 0.52) | 0.001 |
Urinary leakage | 21 (1) | 49 (5) | 0.08 (0.02, 0.21) | <0.001 |
Length of stay (d) | 4 (3, 5) | 6 (5, 7) | –2 (–2, –1) | <0.001 |
Functional outcomes | ||||
Off-clamp procedure | 280 (12) | 200 (19) | 0.32 (0.25, 0.41) | 0.0001 |
Warm ischemia time (min) | 16 (11, 22) | 15 (8, 21) | +4.3 (+3, +5) | <0.001 |
Postoperative eGFR | 76 (60, 89) | 78 (63, 93) | –6 (–8, –4) | <0.001 |
1-yr eGFR | 71 (56, 88) | 68 (55, 87) | –1 (–2, +1) | 0.5 |
Oncologic outcomes | ||||
Positive surgical margins | 103 (4) | 55 (5) | 0.53 (0.27, 0.99) | 0.05 |
Local recurrence | 97% (95%, 98%) | 96% (95%, 98%) | 1.02 (0.51, 2.04) | 0.9 |
Systemic progression | 94% (92%, 96%) | 92% (89%, 94%) | 1.18 (0.61, 2.29) | 0.6 |
Cancer-specific mortality | 97% (96%, 99%) | 98% (97%, 99%) | 0.99 (0.33, 2.90) | 0.9 |
3.2.2 Complications

3.2.3 Renal function
3.2.4 Oncologic outcomes
3.3 Predictors of oncologic outcomes after RAPN
Predictors | Outcome of interest | |||
---|---|---|---|---|
Local recurrence | Systemic progression | |||
HR (95% CI) | p value | HR (95% CI) | p value | |
Preoperative model (n = 1687, patients treated with RAPN with available follow-up data) | ||||
Age at diagnosis | 1.03 (1.00, 1.06) | 0.02 | 1.00 (0.97, 1.03) | 0.8 |
Gender | ||||
Male | Ref. | 0.03 | – | 0.07 |
Female | 0.41 (0.18, 0.95) | 0.48 (0.22, 1.07) | ||
Clinical tumor size | 1.25 (1.07, 1.47) | 0.004 | 1.20 (1.01, 1.43) | 0.03 |
PADUA score | 1.09 (0.89, 1.33) | 0.4 | 1.17 (0.95, 1.43) | 0.1 |
Year of surgery | 0.91 (0.79, 1.05) | 0.2 | 0.91 (0.78, 1.05) | 0.2 |
C-index | 0.73 | 0.77 | ||
Postoperative model (n = 1333, patients with malignancy on final pathology after RAPN with available follow-up data) | ||||
Age at diagnosis | 1.01 (0.99, 1.05) | 0.2 | 0.98 (0.96, 1.01) | 0.4 |
Gender | ||||
Male | Ref. | 0.1 | – | 0.4 |
Female | 0.53 (0.23, 1.25) | 0.71 (0.33, 1.53) | ||
Pathologic tumor size | 1.21 (1.14, 1.44) | 0.033 | 1.26 (1.08, 1.47) | 0.003 |
Pathologic tumor grade | ||||
G1–2 | Ref. | 0.001 | – | 0.1 |
G3–4 | 3.54 (1.66, 7.56) | 1.67 (0.83, 3.37) | ||
Type of malignant histology | ||||
Other | Ref. | 0.01 | – | 0.1 |
Clear cell RCC | 3.26 (1.23, 8.60) | 2.10 (0.85, 5.15) | ||
Positive surgical margins | ||||
No | Ref. | 0.003 | – | 0.7 |
Yes | 3.85 (1.55, 9.52) | 1.28 (0.30, 5.40) | ||
Year of surgery | 0.88 (0.75, 1.03) | 0.1 | 0.93 (0.79, 1.09) | 0.4 |
C-index | 0.81 | 0.79 |
4. Discussion
Bravi CA, Dell'Oglio P, Mazzone E, et al. The surgical learning curve for biochemical recurrence after robot-assisted radical prostatectomy. Eur Urol Oncol. In press. https://doi.org/10.1016/j.euo.2022.06.010.
5. Conclusions
Appendix A. Supplementary data
- Supplementary data 1
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