A Propensity-Matched Comparison of the Perioperative Outcomes Between Single-Port and Multi-Port Robotic Assisted Partial Nephrectomy: A Report from the Single Port Advanced Research Consortium (SPARC)

Abstract

Purpose:

Single-port (SP) robotic surgery is a new technology and early in its adoption curve. The goal of this study is to compare the perioperative outcomes of SP to multi-port (MP) robotic technology for partial nephrectomy.

Materials and Methods:

This is a prospective cohort study of patients who have undergone robot-assisted partial nephrectomy using SP and MP technology. Baseline demographic, clinical, and tumor-specific characteristics and perioperative outcomes were compared using χ ², t-test, and Mann–Whitney U test in the overall cohort and in a 1:1 propensity score-matched cohort, adjusting for baseline characteristics.

Results:

After propensity matching, 146 SP patients were matched with 146 MP patients. SP and MP groups had similar mean age (58 ± 12 years vs 59 ± 12 years; p = 0.606) and proportion of men (54.11% vs 52.05%; p = 0.725). The SP had a longer mean ischemia (18.29 ± 10.49 minutes vs 13.79 ± 6.29 minutes; p < 0.001). Estimated blood loss (EBL) and length of hospital stay (LOS), operative time, positive margin rate, and any complication rate were similar between the two groups.

Conclusions:

SP partial nephrectomy had a longer ischemia time, and a comparable LOS, EBL, operative time, positive margin rates, and complication rates to MP. These early data are encouraging. However, the role of SP requires further study and should evaluate safety and long-term data when compared with the standard MP technique.

Introduction

It has been three decades since the initial report of minimally invasive partial nephrectomy.¹ Since then, the experience grew with laparoscopy, and large series demonstrated comparable oncological and functional outcomes to open partial nephrectomy.^2,3 Efforts were made to further minimize the morbidity via single-port (SP) laparoscopic surgery.⁴ Even though successful attempts were made,⁵ SP laparoscopy was technically challenging and did not become widely popular. Then came along the robotic platforms, which overcame some of the technical limitations of laparoscopy and helped popularize minimally invasive partial nephrectomy. Over time, robotic approach became the most common way to perform partial nephrectomy in the United States.⁶ Efforts have been made to further minimize the morbidity through SP robotic surgery with success.⁷ However, the previous robotic platforms were not designed for SP surgery and ergonomic issues prevented widespread use.⁸

In 2018, United States Food and Drug Administration approved the use of a purpose-built SP robotic surgical platform to perform partial nephrectomy. This SP system allowed the use of three double-jointed instruments and a camera through a single 2.5 cm cannula. This novel SP platform revitalized the interest in SP robotic surgery. In 2019, Kaouk et al published the initial series of robotic partial nephrectomy using the SP system.⁹ In the following period, promising perioperative outcomes were reported in partial nephrectomy setting.^10

–13 However, the previous studies in literature were mostly single-center studies with single-arm design and limited sample sizes. Herein, we are reporting the comparative outcomes of SP vs MP RPN from a multi-institutional collaboration.

Patients and Methods

Data source

We conducted a cohort study of patients who have undergone RPN using the Single Port Advanced Research Consortium database of nine institutions in the United States. The database is prospectively maintained and captures patient's baseline demographic, clinical, and tumor-specific characteristics in addition to perioperative and follow-up data on postoperative outcomes between 2015 and 2021. Center-specific institutional ethics review board approval and data sharing agreements were obtained before patient identification, data collection, or de-identified data transfer. De-identified data are maintained and stored at the Icahn School of Medicine at Mount Sinai, NY.

Study population

All patients, at least 18 years of age who had undergone surgical management of a renal mass were identified. To be eligible for study inclusion, a patient would have had RPN via SP or MP approach. Patients from all centers irrespective of the number of SP or MP cases performed by the centers were included in the study (Supplementary Table S1).

Study variables

Baseline demographic, clinical, and tumor-specific characteristics considered in our analysis include age, gender, body mass index (BMI), tumor laterality, hypertension status, diabetes mellitus status, tumor size, and radius, endophytic/exophytic, nearness to collecting system or sinus, anterior/posterior, location relative to the polar lines (R.E.N.A.L nephrometry score).¹⁴ Tumor complexity was defined using the RENAL nephrometry score (low tumor complexity [4–6], moderate tumor complexity [7–9], and high tumor complexity [10–12]).¹⁴ We also evaluated the pathological characteristics of the renal mass—pathological tumor size, tumor pathology, and pathological tumor stage.

Outcome variables

The outcomes of interest were perioperative: operative time, ischemia time, estimated blood loss (EBL), length of hospital stay (LOS), positive margin rate, and any complication rate.

Statistical analysis

Categorical variables are reported as frequencies and percentages, while continuous variables are reported as means and standard deviation (SD) or medians and interquartile ranges depending on the distribution of the variable. Bivariate relationships were evaluated using χ ² and Fisher's exact test for categorical variables and student t-test and Mann–Whiney U test for continuous variables.

To minimize confounding, we used a propensity score to determine the probability of having either an SP or multi-port (MP) robotic partial nephrectomy based on observable patient characteristics. A probit regression model was used to estimate the propensity score, and the variables included were age, gender, BMI, tumor laterality, hypertension status, diabetes status, tumor size, and R.E.N.A.L nephrometry score. The performing surgeon was also added to the model to control for potential variability in surgical outcomes.

With the estimated propensity scores, the SP robotic group was matched with the MP robotic group in a 1:1 ratio by using the nearest neighbor matching algorithm without replacement. A caliper of the maximum distance between the two groups was set at 0.05. The matching outcome was evaluated visually, using charts, and using the standardized mean differences. We considered a standardized mean difference <0.10 as a negligible imbalance.

In a subset analysis, using the propensity matched cohort, we evaluated the relationship between the type of robotic port technology and perioperative outcomes stratified by tumor complexity to determine the type of cases defined by tumor complexity that are most appropriate with the technology early its adoption phase.

All analyses were performed from February 16, 2021, to August 18, 2021, using Stata/MP, version 14.1 (StataCorp, College Station, TX) with the psmatch2 package. All p-values were 2-sided, and statistical significance was determined at a p < 0.05.

Results

Baseline characteristics—overall cohort

A total of 1726 patients were included in this study: MP (n = 1578, 91.43%) and SP (n = 148, 8.57%). Baseline demographic, clinical, and tumor-related characteristics of the study cohort are presented in Table 1. Compared to the MP group, the SP group was relatively of similar mean age (mean ± SD; 58 ± 12 years vs 60 ± 12 years; p = 0.105) and had a lower proportion of men (54.05% vs 62.48%; p = 0.044). A higher proportion of the SP group had hypertension compared with the MP group (65.54% vs 54.63%; p = 0.011). Similarly, the SP had a lower mean tumor size (2.93 ± 1.33 cm vs 3.42 ± 1.96 cm; p = 0.0001) and a significantly lower median R.E.N.A.L (6 [interquartile range (IQR): 5, 8] vs 7 [IQR: 6, 9]; p = < 0.001) score compared with the MP group.

Table 1.

Descriptive Characteristics of the Study Cohort

	Unmatched cohort		p	SMD	1:1 propensity matched cohort		p	SMD
	n (%)	n (%)			n (%)	n (%)
	MP	SP			MP	SP
n (%)	1578 (91.43)	148 (8.57)			146 (50)	146 (50)
Age, year, mean ± SD	60 ± 12	58 ± 12	0.105^a	0.140	59 ± 12	58 ± 12	0.606^a	0.058
Gender			0.044 ^b	0.171			0.725^b	0.042
Female	592 (37.52)	68 (45.95)			70 (47.95)	67 (45.89)
Male	986 (62.48)	80 (54.05)			76 (52.05)	79 (54.11)
Laterality			0.076^b	0.153			0.723^b	0.041
Left	792 (50.19)	63 (42.57)			65 (44.52)	62 (42.47)
Right	786 (49.81)	85 (57.43)			81 (55.48)	84 (57.53)
BMI, kg/m² mean ± SD	30.10 ± 6.59	30.03 ± 6.53	0.899^a	0.011	30.06 ± 6.86	30.15 ± 6.48	0.899^a	0.015
Hypertension			0.011 ^b	0.224			0.903^b	0.014
No	716 (45.37)	51 (34.46)			52 (35.62)	51 (34.93)
Yes	862 (54.63)	97 (65.54)			94 (64.38)	95 (65.07)
Diabetes			0.988^b	0.001			0.580^b	0.066
No	1236 (78.33)	116 (78.38)			110 (75.34)	114 (78.08)
Yes	342 (21.67)	32 (21.62)			36 (24.66)	32 (21.92)
Tumor size, cm mean ± SD	3.42 ± 1.96	2.93 ± 1.33	0.0001 ^a	0.258	2.96 ± 1.61	2.94 ± 1.34	0.919^a	0.064
R.E.N.A.L score median (IQR)	7 (6, 9)	6 (5, 8)	<0.001 ^c	0.377	6 (5, 8)	6 (5, 8)	0.890^a	0.031

The figures in bold are significant at p < 0.05.

t-Test.

χ ² test.

Mann–Whitney U test.

BMI = body mass index; IQR = interquartile range; MP = multi-port; R.E.N.A.L score/R.E.N.A.L nephrometry score = (radius, endophytic/exophytic, nearness to collecting system or sinus, anterior/posterior, location relative to the polar lines)—renal tumor characteristics used to evaluate complexity; SD = standard deviation; SMD = standardized mean difference (absolute difference in means divided by the SD); SP = single-port.

Baseline characteristics—propensity score-matched cohort

In the propensity score-matched cohort, a total of 292 patients were included in the analysis: MP (n = 146, 50%) and SP (n = 146, 50%). The standardized mean difference between the two groups was negligible (Table 1). SP and MP groups were similar with regards to age (58 ± 12 years vs 59 ± 12 years; p = 0.606), proportion of men (54.11% vs 52.05%; p = 0.725), and proportion of patients with hypertension (65.07% vs 64.38%; p = 0.903). The mean tumor size (2.94 ± 1.34 cm vs 2.96 ± 1.61 cm; p = 0.919) and median R.E.N.A.L score (6 [IQR: 5, 8] vs 6 [IQR: 5, 8]; p = 0.890) were also relatively similar between the MP and SP groups. Other comparisons are presented in Table 1.

Perioperative outcomes

In the propensity matched cohort (Table 2), the SP group had longer mean ischemia time (18.29 ± 10.49 minutes vs 13.79 ± 6.29 minutes; p < 0.001). Conversely, SP and MP groups were comparable with regards to EBL (89.38 ± 111.19 mL vs 112.46 ± 157.29 mL; p = 0.151) and LOS (1.19 ± 1.90 days vs 1.33 ± 1.05 days; p = 0.422), operative time (137.02 ± 59.59 minutes vs 142.35 ± 60.69 minutes; p = 0.479), positive margin rate (6.16% vs 4.79; p = 0.254), and any complication rate (8.22% vs 6.16%; p = 0.209).

Table 2.

Bivariate Relationship Between the Type of Robotic Port Technology and Perioperative Outcomes

	Unmatched cohort		p	Propensity matched cohort		p
	n (%)	n (%)		n (%)	n (%)
	MP	SP		MP	SP
Operative time, minutes, mean ± SD	146.29 ± 55.23	137.09 ± 59.49	0.059^a	142.35 ± 60.69	137.02 ± 59.59	0.479^a
Ischemia time, minutes, mean ± SD	14.56 ± 6.87	18.17 ± 10.44	0.0002 ^a	13.79 ± 6.29	18.29 ± 10.49	<0.001 ^a
EBL, mL, mean ± SD	122.61 ± 164.23	88.85 ± 110.52	0.001 ^a	112.46 ± 157.29	89.38 ± 111.19	0.151^a
LOS, days, mean ± SD	1.52 ± 1.70	1.52 ± 1.89	0.026 ^a	1.33 ± 1.05	1.19 ± 1.90	0.422^a
Positive margins
No	2737 (95.70)	139 (93.92)	0.303^b	139 (95.21)	137 (93.84)	0.254^b
Yes	123 (4.30)	9 (6.08)		7 (4.79)	9 (6.16)
Any complication
No	2547 (89.06)	136 (91.89)	0.279^b	137 (93.84)	134 (91.78)	0.497^b
Yes	313 (10.94)	12 (8.11)		9 (6.16)	12 (8.22)

The figures in bold are significant at p < 0.05.

t-Test.

χ ² test

EBL = estimated blood loss; LOS = length of hospital stay.

We compared the perioperative outcomes stratified by tumor complexity (Table 4). Warm ischemia time of the SP group was longer in the low (16.31 ± 11.08 minutes vs 11.61 ± 5.23 minutes; p = 0.002) and intermediate complexity groups (19.12 ± 9.18 minutes vs 15.32 ± 6.26 minutes; p = 0.019). Operative time of the SP group was shorter (108.27 ± 39.09 vs 167.71 ± 55.5 minutes) for the high complexity group. Irrespective of tumor complexity, other perioperative outcomes were comparable between the two approaches.

Oncological outcomes

With regards to pathologic outcomes among the matched cohort (Table 3), the median pathological tumor size was similar between the MP (2.82 ± 1.34 cm) and SP group (2.92 ± 1.32 cm). The most common tumor stage was PT1a (82.19%, MP vs 80.82, SP), and clear cell (52.05%, MP vs 53.42%, SP) was the most common tumor pathology.

Table 3.

Pathological Outcomes in the Propensity Matched Cohort

	MP	SP
	n (%)	n (%)
Pathological tumor size, cm^a	2.82 ± 1.34	2.92 ± 1.32
Tumor pathology
Clear cell	76 (52.05)	78 (53.42)
Chromophobe	11 (7.53)	9 (6.16)
Papillary	1 (0.68)	2 (1.37)
Oncocytoma	7 (7.44)	4 (2.74)
Angiomyolipoma	7 (12.40)	13 (8.90)
Others	39 (26.71)	40 (27.40)
Missing	5 (3.42)	0 (0.00)
Pathological stage
pT1a	120 (82.19)	118 (80.82)
pT1b	19 (13.01)	15 (10.27)
pT2a	0 (0.00)	4 (2.74)
pT3a	6 (4.11)	3 (2.05)
Missing	1 (0.68)	6 (4.11)

Mean ± SD.

Table 4.

Bivariate Relationship Between the Type of Robotic Port Technology and Perioperative Outcomes Stratified by Tumor Complexity

	Low (4–6)			Intermediate (7–9)			High (10–12)
	MP	SP	p	MP	SP	p	MP	SP	p
n (%)	74 (48.37)	79 (51.63)		63 (54.78)	52 (45.22)		9 (37.50)	15 (62.50)
Operative time, minutes, mean ± SD	130.40 ± 42.48	138.02 ± 55.21	0.364^a	152.24 ± 75.19	144.20 ± 69.23	0.580^a	167.71 ± 55.55	108.27 ± 39.09	0.009 ^a
Ischemia time, minutes, mean ± SD	11.61 ± 5.23	16.31 ± 11.08	0.002 ^a	15.32 ± 6.26	19.12 ± 9.18	0.019 ^a	20.11 ± 7.15	25.62 ± 8.33	0.123^a
EBL, mL, mean ± SD	99.93 ± 181.89	77.72 ± 104.33	0.352^a	116.72 ± 100.45	97.60 ± 117.99	0.354^a	186.67 ± 238.43	122.33 ± 120.39	0.387^a
LOS, days, mean ± SD	1.32 ± 1.12	1.04 ± 1.80	0.247^a	1.22 ± 0.53	1.42 ± 2.29	0.541^a	2.11 ± 2.26	1.13 ± 0.30	0.232^a
Positive margins
No	72 (97.30)	74 (93.67)	0.444^b	58 (92.06)	50 (96.15)	0.306^b	9 (100.00)	13 (86.67)	0.511^b
Yes	2 (2.70)	5 (6.33)		5 (7.94)	2 (3.85)		0 (0.00)	2 (13.33)
Any complication
No	70 (94.59)	74 (93.67)	1.000^b	59 (93.65)	46 (88.46)	0.344^b	8 (88.89)	14 93.33)	1.000^b
Yes	4 (5.41)	5 (6.33)		4 (6.35)	6 (11.54)		1 (11.11)	1 (6.67)

The figures in bold are significant at p < 0.05.

t-Test.

Fisher's exact test.

Discussion

The SP surgical system is new, and the SP cases in this study are the initial cases of experienced surgeons. Thus, most cases (52.40%) in our study had a low tumor complexity, which is to be expected since it is more appropriate and safer to perform earlier cases for less complex renal masses. In our matched-pair cohort, both groups had a mean tumor size of ∼2.9 cm and median RENAL nephrometry score of 6. Our early results demonstrated comparable perioperative outcomes between MP and SP RPN, and irrespective of the tumor complexity, the perioperative outcomes were also comparable. We focused our analysis on the perioperative outcomes, as the primary goal was to demonstrate the safety of the SP RPN irrespective of the port configuration or the used anatomical space. Our results show that the complication rate was comparable between the two groups, without compromising the margin rates. We were unable to analyze the functional outcomes or recurrence as the median follow-up was very short.

The SP RPN has some technical challenges associated with it. First, the SP system is designed to operate in small anatomical spaces. This is beneficial in retroperitoneal RPN, as less space is required as opposed to MP RPN and there is limited to no need for peritoneal mobilization. However, in transperitoneal cases, the bedside assistant will occasionally have to reposition the robot, as the system works in a limited working space that needs to be adjusted frequently in large anatomical spaces. A challenge could be the insertion of the ultrasound probe. The floating docking technique addresses this issue as the probe can be inserted through the assistant port through the gelport.¹⁵ Next, RPN requires the frequent use of Weck® clips. The dedicated SP clip applier can only use a medium-large clip, which is smaller than the large clips that are commonly used during RPN.

Furthermore, during renorrhaphy frequent clipping is required. Each time a clip is applied, the applier must be removed, loaded, and inserted. This process can prolong the ischemia time. To get around the clip and ultrasound probe problems, an additional 12 mm assistant port can be inserted. Our cohort consisted of various technical approaches with or without the additional port. Despite the clinical challenges, we observed comparable operative time and longer ischemia time in the SP group (18 vs 13 minutes, p < 0.001). Although this difference is statistically significant the clinical significance is debatable.

Another technical consideration is the use of the suction systems. As previously mentioned, a second port can be introduced and use conventional suctioning systems. Another alternative would be to use flexible and remotely operated suction irrigation systems. These systems could be introduced through the additional assistant port or through a gelport using the same incision via floating docking technique.¹⁵ Such modifications help the surgeon control his/her own suction during SP surgery and decrease the reliance on the bedside surgeon.¹⁶ The optimal use of the suction will enable better visualization and hemostasis, which helps with tumor excision. After all, the primary goal of RPN is the oncological outcome. In our cohort, the SP group had a comparable EBL and the positive surgical margin rate to the MP group.

One of the key premises of the SP approach is the decreased morbidity and improved postoperative recovery. We did not include postoperative pain scores in our analysis as data was heterogeneous from different centers. A potential benefit is to facilitate same-day discharge after SP RPN. Promising results have been shown in various single-center studies.^17,18 In the current study, mean LOS was ∼1 day. However, our data were not granular enough to do a sub-analysis for same-day discharge comparison. This will be the focus of a future study. Another benefit of the SP system is the ability to work in tight spaces. This will come in handy with the retroperitoneal approach. It can be challenging to create the optimal retroperitoneal space with the MP robotic platforms. For retroperitoneal RPN, SP approach is likely to decrease the need for peritoneal mobilization and facilitate easier access and docking.

The weakness of our study lies in the retrospective design and the inherent selection bias. In this analysis, it is difficult to capture why a patient was offered SP RPN as opposed to a MP approach. We tried to limit the selection bias by a matched-pair analysis. However, there may be additional or unmeasured confounders that cannot be adjusted using the propensity score matching method. Our sample size is limited as well. However, this is to be expected given the recency of the available SP platform. The surgeons in this study are high-volume and experienced robotic surgeons, which limits the reproducibility of our results. Moreover, we are missing long-term oncological and functional results. These will be the focus of the future studies. The strength of the study lies in the multi-institutional design. To our knowledge, this is the largest study in literature to compare the perioperative outcomes of SP and MP RPN.

Conclusion

Early results demonstrated that in select cases, perioperative outcomes are comparable between SP and MP RPN. Our results need to be validated with future studies with larger sample sizes and longer follow-up.

Footnotes

Authors' Contributions

K.E.O.: writing—original draft; formal analysis; data curation; methodology; project administration; writing—review and editing. A.T.B.: writing—original draft; data curation; methodology; writing—review and editing. M.P.W.: writing—review and editing. T.G.K.: data curation, project administration. K.N.M.: data curation. R.H.: data curation. L.H.: data curation. M.A.: resources; data curation; conceptualization. R.M.: resources; data curation. R.A.: resources; data curation; conceptualization. D.D.E.: resources; data curation; conceptualization. A.B.: resources; data curation; conceptualization. A.K.H.: resources; data curation; conceptualization. J.P.: resources; data curation; conceptualization. M.D.S.: resources; data curation; conceptualization. J.K.: resources; data curation; conceptualization. S.C.: resources; data curation; conceptualization. K.K.B.: supervision; conceptualization, resources; writing—review and editing.

Author Disclosure Statement

Dr. Ronney Abaza is a lecturer for Intuitive Surgical Inc. and VTI Inc. Dr. Michael Stifelman is on the scientific advisory board of Intuitive Surgery and has an educational agreement with Ethicon. Dr. Mutahar Ahmed is a consultant for CONMED and Intuitive Surgical. Jihad Kaouk is a consultant for Intuitive Surgical. The remaining authors declare that they have no relevant financial interest.

Funding Information

No funding was received for this article.

Supplementary Material

Supplementary Table S1

Abbreviations Used

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