Short-term Results after Robot-assisted Laparoscopic Radical Prostatectomy Compared to Open Radical Prostatectomy

EURURO-5875; No. of Pages 11 EUROPEAN UROLOGY XXX (2014) XXX–XXX

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Short-term Results after Robot-assisted Laparoscopic Radical Prostatectomy Compared to Open Radical Prostatectomy Anna Wallerstedt a,*, Stavros I. Tyritzis a, Thordis Thorsteinsdottir b,c, Stefan Carlsson a, Johan Stranne d, Ove Gustafsson e, Jonas Hugosson d, Anders Bjartell f, Ulrica Wildera¨ng b, N. Peter Wiklund a, Gunnar Steineck b,g, Eva Haglind h, on behalf of the LAPPRO steering committee a

Department of Molecular Medicine and Surgery, Section of Urology, Karolinska Institutet, Solna, Stockholm, Sweden;

b

Division of Clinical Cancer

Epidemiology, Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden; c Faculty of Nursing, School of Health Sciences, University of Iceland, Reykjavik, Iceland; d Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden;

e

Department of Clinical Science, Intervention and Technology,

f

Karolinska Institutet, Solna, Stockholm, Sweden; Department of Urology, Ska˚ne University Hospital, Lund University, Lund, Sweden; Oncology and Pathology, Division of Clinical Cancer Epidemiology, Karolinska Institutet, Solna, Stockholm, Sweden;

h

g

Department of

Department of Surgery, Institute of

Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden

Article info

Abstract

Article history: Accepted September 23, 2014

Background: Robot-assisted laparoscopic radical prostatectomy has become a widespread technique despite a lack of randomised trials showing its superiority over open radical prostatectomy. Objective: To compare in-hospital characteristics and patient-reported outcomes at 3 mo between robot-assisted laparoscopic and open retropubic radical prostatectomy. Design, setting, and participants: A prospective, controlled trial was performed of all men who underwent radical prostatectomy at 14 participating centres. Validated patient questionnaires were collected at baseline and after 3 mo by independent health-care researchers. Outcome measurements and statistical analysis: The difference in outcome between the two treatment groups were analysed using logistic regression analysis, with adjustment for identified confounders. Results and limitations: Questionnaires were received from 2506 (95%) patients. The robot-assisted surgery group had less perioperative bleeding (185 vs 683 ml, p <0.001) and shorter hospital stay (3.3 vs 4.1 d, p < 0.001) than the open surgery group. Operating time was shorter with the open technique (103 vs 175 min, p < 0.001) compared with the robot-assisted technique. Reoperation during initial hospital stay was more frequent after open surgery after adjusting for tumour characteristics and lymph node dissection (1.6% vs 0.7%, odds ratio [OR] 0.31, 95% confidence interval [CI 95%] 0.11–0.90). Men who underwent open surgery were more likely to seek healthcare (for one or more of 22 specified disorders identified prestudy) compared to men in the robot-assisted surgery group ( p = 0.03). It was more common to seek healthcare for cardiovascular reasons in the open surgery group than in the robot-assisted surgery group, after adjusting for nontumour and tumour-specific confounders, (7.9% vs 5.8%, OR 0.63, CI 95% 0.42–0.94). The readmittance rate was not statistically different between the

Keywords: Radical prostatectomy Open Robot-assisted Complications Short-term results

* Corresponding author. Department of Molecular Medicine and Surgery, Section of Urology, Karolinska Institutet, Solna, Stockholm, Sweden. E-mail address: [email protected] (A. Wallerstedt). http://dx.doi.org/10.1016/j.eururo.2014.09.036 0302-2838/# 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Please cite this article in press as: Wallerstedt A, et al. Short-term Results after Robot-assisted Laparoscopic Radical Prostatectomy Compared to Open Radical Prostatectomy. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.09.036

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groups. A limitation of the study is the lack of a standardised tool for the assessment of the adverse events. Conclusions: This large prospective study confirms previous findings that robot-assisted laparoscopic radical prostatectomy is a safe procedure with some short-term advantages compared to open surgery. Whether these advantages also include long-term morbidity and are related to acceptable costs remain to be studied. Patient summary: We compare patient-reported outcomes between two commonly used surgical techniques. Our results show that the choice of surgical technique may influence short-term outcomes. # 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

1.

Introduction

prostatectomies. The prespecified statistical analysis plan is available as supplementary material.

Surgery-induced problems in the short term may cause suffering for the patient and increased costs for the health care system. Arguments for the introduction of laparoscopic techniques include the contention that a smaller wound, as compared to that produced by open surgery, would result in less bleeding and fewer infections as well as a shorter length of hospital stay. Evolving data supporting these assumptions and experiences suggest that the same pattern may hold for robot-assisted laparoscopic radical prostatectomy as compared with open surgery [1–3]. There are currently no large prospective studies comparing the short-term results of robot-assisted laparoscopic prostatectomy and open radical prostatectomy. The magnitude of the probable improvement in short-term outcomes through use of the robot-assisted technique is, therefore, still unknown, as is the effect on short-term outcomes other than infections, bleeding, and length of hospital stay [4,5]. In order to assess potential differences between the two types of procedure, we initiated a prospective controlled trial at 14 centres in Sweden performing radical prostatectomy, collecting information from both health-care professionals and patients. The aim of this study was to report the frequency of certain prespecified short-term results and adverse events after both robot-assisted laparoscopic radical prostatectomy and open retropubic radical prostatectomy, and to investigate potential differences between the two procedures.

2.2.

Patients

To avoid problems due to physician selection, we aimed to collect data from all men diagnosed with prostate cancer and planned for radical prostatectomy at the 14 participating centres from September 1, 2008 to November 7, 2011. For a majority of those participating, geographical residency decided the technique used, not patient or surgeon preferences. For this report, the inclusion criteria were age <75 yr, ability to read and write Swedish, informed consent, tumour stage cT1, cT2, or cT3 (TNM Classification of Malignant Tumors) [7] with no signs of distant metastases, and a prostate-specific antigen level of <20 ng/ml. To diminish the influence of the learning curve, we only included men who were operated on by a surgeon with experience of at least 100 procedures as primary surgeon.

2.3.

Data collection

The study-specific clinical record forms were tested face-to-face with relevant health-care professionals. The study questionnaires reporting patient outcomes have the same clinometric approach as a previous randomised controlled trial, and more than 20 large data collections of cancer survivors [8]. The basic idea was to categorise symptoms and other phenomena by asking questions about them one by one [9]. The validation of the questionnaires and the pilot study performed before the start of the study has been described earlier [6]. During the trial, research nurses and surgeons filled out the clinical record forms. The centres were regularly asked to supply missing information and to check suspected outliers. Two research nurses monitored the recruiting sites. The preoperative questionnaire was given to the patient before surgery and collected at the recruiting departments. The 3-mo questionnaires

2.

Patients and methods

were sent from the trial secretariat [6] (Table 1).

2.1.

Overview

surgery?’’ with answer categories ‘‘Yes’’ and ‘‘No’’. The patient could then

At 3 mo, we asked ‘‘Have you been readmitted to the hospital after the specify in free text the reason for readmittance. This information was This prospective controlled trial, LAPPRO (Laparoscopic Prostatectomy

classified into different groups in a blinded fashion (Table 2). The question

Robot Open), recruited patients from seven centres using the robot-

‘‘Have you sought medical care because of any of the following disorders

assisted approach and seven centres performing open surgery. Patient-

after surgery?’’ had 22 specified disorders as answer categories, followed

reported data were collected before and 3 mo after surgery by a neutral

by ‘‘Yes’’ and ‘‘No’’ options. From this question, we calculated the

third-party trial secretariat. Health-care professionals completed clinical

probability of seeking health care by dichotomising between ‘‘never’’ and

record forms before, during, and 1.5–3 mo, 12 mo, and 24 mo after

‘‘once or more’’.

surgery. The time point for measuring adverse events on patient reports

During the recruitment period, a number of quality assurance efforts

was set at 3 mo postoperatively. Further details can be found in the

were made regarding the data. The information was entered manually

publication describing the study [6] and in the protocol available

into electronic files. Approximately 1% of the records and questionnaires

on www.ssorg.net. The Regional Ethical Review Board in Gothenburg

were entered twice and compared.

(No 277-07) approved the study. The trial is registered in the Current Controlled Trials database (ISRCTN06393679).

2.4.

Statistical analysis

LAPPRO is an external scientific review of the two surgical techniques, as neither the principal investigator (E.H.) nor the deputy

The statistical analysis plan defines the outcomes for this article, effect

principal investigator (G.S.) is a urologist and neither performs radical

measures, and possible confounders and mediators, as well as certain

Please cite this article in press as: Wallerstedt A, et al. Short-term Results after Robot-assisted Laparoscopic Radical Prostatectomy Compared to Open Radical Prostatectomy. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.09.036

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Table 1 – Baseline characteristics of the patients Variable

a,d

Open surgery (n = 778)

b

Robot-assisted surgery (n = 1847)

Age at surgery (yr) 63 (42–75) Median 59–67 Quartiles Educational level, n (%) 246 (35.5) University/college (>13 yr in school) Technical training school (12–13 yr in school) 80 (11.5) 208 (30.0) High school (10–12 yr in school) 143 (20.6) Elementary school (9 yr in school) 14 (2.0) Other 3 (0.4) Not stated ASA e classification number, n (%) 508 (66.6) I 218 (28.6) II 15 (2.0) III 22 (2.9) Not stated Body mass index (kg/m2) 26.2 (18.2–38.2) Median (range) 24.5–28.1 Quartiles 12 Not stated Preoperative PSA (ng/ml) 6.2 (0.7–20.0) Median (range) Quartiles 4.5–9.0 19 Not stated (n) Clinical tumour stage number, n (%) T1 494 (64.7) 218 (28.6) T2 27 (3.5) T3 Not stated 24 (3.2) Gleason score biopsy 716 (93.8) 7 8 45 (5.9) Not stated 2 (0.3) Total length of cancer in prostate biopsy (mm) Median (interquartile range) 7.0 (3.2–14.9) 78 Not stated (n) Postoperative prostate weight, n (%) 0–19 g 4 (0.5) 267 (35.5) 20–39 g 334 (44.4) 40–59 g 60–79 g 96 (12.8) 80 g 51 (6.8) Neurovascular bundle–preserving procedure, n (%) Yes 516 (67.8) 244 (32.1) No 1 (0.1) Not stated Lymph node dissection, n (%) 48 (6.3) Extended 155 (20.4) Limited Not done 554 (72.8) 4 (0.5) Not stated Median time between surgery and answering of 3-mo questionnaire (mo) Median (range) 3.1 (3.1–9.3) 3.1–3.1 Quartiles 88 Not stated (n)

63 (37–75) 58-66

c

p value

0.03

691 184 462 254 30 9

(42.4) (11.3) (28.3) (15.6) (1.8) (0.6)

0.009

1113 646 43 42

(60.4) (35.0) (2.3) (2.3)

0.005

25.9 (18.8–54.3) 24.1–28.0 32

0.03

6.1 (0.09–20.0) 4.5–8.9 8

0.73

1099 652 57 36

(59.6) (35.4) (3.1) (2.0)

1732 (93.9) 102 (5.5) 10 (0.5) 7.5 (4.0–16.0) 92 18 782 729 209 86

0.006

0.72

0.03

(1.0) (42.9) (40.0) (11.5) (4.7)

0.003

1556 (84.4) 284 (15.4) 3 (0.2)

<0.001

162 63 1607 11

<0.001

(8.8) (3.4) (87.2) (0.6)

3.1 (3.1–12.4) 3.1–3.1 194

0.74

PSA = prostate-specific antigen. Total may not add up to 100 due to rounding of percentages. b Denotes retropubic radical prostatectomy. c Denotes robot-assisted laparoscopic radical prostatectomy. d No statistical difference was found between the occurrence of diabetes, cardiovascular disease, pulmonary disease, kidney disease, previous abdominal surgery, and previous transurethral resection of the prostate (TURP). e ASA classification: I = normal healthy patient; II = mild systemic disease; III = severe systemic disease. a

sensitivity analyses. A power calculation was done to detect a difference on

adjustment was made for multiple testing, which is a limitation of the

the primary endpoint of the LAPPRO study; urinary leakage at 12 mo

study.

(significance level p = 0.05, 80% power, two-sided test). All the outcomes

Missing information on prostate weight was imputed by making a

for the short-term results were defined before the start of the study, which

linear regression model of postoperative prostate weight, as predicted by

reduces the risk of differences that arise by chance. However, no

preoperative prostate volume among men for whom information was

Please cite this article in press as: Wallerstedt A, et al. Short-term Results after Robot-assisted Laparoscopic Radical Prostatectomy Compared to Open Radical Prostatectomy. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.09.036

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EUROPEAN UROLOGY XXX (2014) XXX–XXX

Table 2 – Possible associated factors for patient-reported readmission to hospital after open surgery and robot-assisted surgery Factor

Group

Readmissions, n (%)

RR (95% CI)

a

Age-adjusted RR (95% CI)

Age at surgery 37–59 yr 60–69 yr 70–75 yr Body mass index (kg/m2) 30 >30 Preoperative PSA <4.5 ng/ml 4.5–6.1 ng/ml 6.2–9.1 ng/ml 9.2 ng/ml Lymph node dissection No Yes Prostate weight 0–19 g 20–39 g 40–59 g 60–79 g 80 g Clinical tumour stage T1 T2 T3 Tumour stage of prostatectomy specimen pT2 pT3 pT4 Gleason score for biopsy cores 7 8 Gleason score for pathologic specimen 7 8 IPSS irritative symptoms preoperatively Mild (0–7) Moderate (8–19) Severe (20–35) Mental disorder No Yes

61 (8.0) 135 (9.1) 24 (9.3)

1.0 1.14 (0.85–1.52) 1.16 (0.74–1.82)

NA NA NA

172 (8.8) 19 (8.0)

1.0 0.92 (0.58–1.44)

1.0 0.91 (0.58–1.44)

(5.6) (9.8) (8.4) (10.9)

1.0 1.75 (1.17–2.62) 1.49 (0.98–2.26) 1.95 (1.30–2.92)

1.0 1.73 (1.15–2.60) 1.47 (0.96–2.23) 1.89 (1.25–2.85)

157 (7.6) 60 (14.2)

1.0 1.86 (1.41–2.45)

1.0 1.82 (1.38–2.41)

1 68 100 26 19

0.66 1.0 1.41 1.29 2.08

0.68 1.0 1.38 1.25 1.98

33 64 55 63

(4.6) (6.9) (9.7) (8.9) (14.4)

(0.10–4.53) (1.05–1.89) (0.84–1.99) (1.30–3.35)

(0.10–4.71) (1.02–1.86) (0.80–1.93) (1.21–3.22)

115 (7.6) 85 (10.2) 14 (18.2)

1.0 1.35 (1.03–1.76) 2.40 (1.45–3.98)

1.0 1.32 (1.01–1.73) 2.36 (1.43–3.92)

138 (7.9) 71 (10.5) 3 (23.1)

1.0 1.34 (1.02–1.76) 2.94 (1.08–8.04)

1.0 1.32 (1.00–1.74) 2.82 (1.02–7.75)

196 (8.4) 18 (12.7)

1.0 1.51 (0.96–2.37)

1.0 1.44 (0.91–2.28)

177 (8.1) 25 (15.5)

1.0 1.92 (1.31–2.83)

1.0 1.88 (1.27–2.79)

90 (7.3) 78 (9.5) 16 (11.2)

1.0 1.29 (0.97–1.73) 1.53 (0.92–2.53)

1.0 1.25 (0.94–1.68) 1.47 (0.89–2.44)

178 (8.3) 15 (19.2)

1.0 2.32 (1.44–3.73)

1.0 2.48 (1.54–3.98)

RR = relative risk; CI = confidence interval; NA = not applicable; PSA = prostate-specific antigen; IPSS = International Prostate Symptom Score. Postoperative irradiation, inguinal hernia, transurethral resection of the prostate (TURP), coronary bypass surgery, diabetes, cardiovascular disease, pulmonary disease, neurologic disease, and kidney disease did not significantly affect the risk of readmission. a

available for both variables. Imputation was performed in R utilizing

In the present study, we report the results unadjusted and after

Multiple Imputations by Chained Equations (MICE) [10] from a data subset

three different adjustments (A, B, and C), where adjustment A is the

which included the confounders, but listed as possible confounders only.

use of stringent confounders which are not likely to affect the surgical

The required variables were added to each imputed dataset.

technique differently in the two groups, thus only affecting the

Possible confounders for each endpoint were selected from

outcome as true confounders (Tables 3, 4 and 5). Adjustment B refers

20 probable risk factors as the variables statistically significantly

to all factors in A with the addition of tumour-related factors that are

associated ( p <0.20) with each specific outcome in over half of the

confounders, but may also be mediating factors, since they may affect

imputed datasets. Relative risks were the percentage of patients with

the surgery differently in the respective surgical groups. Adjustment

that specific outcome in the robot-assisted laparoscopic group divided by

C refers to A and B with the addition of lymph node dissection, which

the percentage of patients with that outcome in the open surgery group.

should also be considered a confounder, but may also be a mediating

The unadjusted relative risks were completed using log binomial

factor due to differences in technique in the respective surgical

regression models, which also provided the 95% confidence intervals

groups.

(CI 95%). In addition, we provided odds ratios (OR), modelled by logistic regression, with the adjusted ratios calculated as a pooled estimate from the 50 imputed datasets. The calculations were performed using the GENMOD procedure in SAS 9.3 for Windows (SAS Institute Incorporated, Cary, NC, USA). To compare the occurrence of possible confounders in the robot-assisted laparoscopic group with the open-surgery group, we calculated p values by chi-square test or Wilcoxon rank-sum test, where appropriate.

3.

Results

We collected data from 4003 men; 980 were excluded because their surgeon had performed <100 operations, and 398 were excluded for not meeting inclusion criteria and for other causes, as stated in the flow chart (Fig. 1). Of

Please cite this article in press as: Wallerstedt A, et al. Short-term Results after Robot-assisted Laparoscopic Radical Prostatectomy Compared to Open Radical Prostatectomy. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.09.036

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Table 3 – Comparison between open surgery and robot-assisted surgery concerning parameters during hospital stay Open surgery b Mean (range) Median (IQR)

Variable

Perioperative bleeding (ml) OR

d

683 (50–8000) 550 (350–800) 103 (40–428) 89 (74–125) 6.7 (1–90) 4.0 (2.8–7.0) 4.1 (1–17) 4 (3–5)

time (min)

Time in recovery unit (h) Length of hospital stay (d)

Open surgery, n (%)

Reoperation during initial hospital stay Mortality during hospital stay

8 (1.6) 0 (0)

b

Robot-assisted surgery, c n (%)

Unadjusted RR (CI 95%) Unadjusted OR (CI 95%)

13 (0.7)

0.47 (0.20–1.13) 0.47 (0.19–1.13) NA

0 (0)

Robot-assisted surgery Mean (range) Median (IQR)

a

c

185 (0–5200) 100 (50–200) 175 (45–575) 168 (144–201) 4.5 (0–45) 4.0 (3.0–5.0) 3.3 (2–53) 3 (2–4)

Adjusted for nontumour confounders d,e OR (CI 95%)

0.46 (0.19–1.14) NA

p value

<0.001 <0.001 0.054 <0.001

Adjusted for A + tumour-specific confounders f OR (CI 95%)

Adjusted for A + B + lymph node dissection g OR (CI 95%)

0.32 (0.12–0.90) NA

0.31 (0.11–0.90) NA

OR time = operating room time ‘‘skin to skin’’; IQR = interquartile range; RR = relative risk; CI = confidence interval; NA = not applicable. Total may not add up to 100 due to rounding of percentages. b Denotes retropubic radical prostatectomy. c Denotes robot-assisted laparoscopic radical prostatectomy. d Possible confounders to be used in adjustments for each outcome were selected as variables significantly associated (p value <0.20) with the specific outcome. e Adjustment A: employment status preoperatively, postoperative irradiation, previous operation for inguinal hernia, previous transurethral resection of the prostate (TURP), pulmonary disease, mental disorder, or kidney disease. f Adjustment B: Adjustment A + tumour factors (preoperative prostate-specific antigen level, clinical tumour stage, tumour stage of prostatectomy specimen, Gleason score on biopsy cores, Gleason score pathology on specimen). g Adjustment C: Adjustment A + B + lymph node dissection. a

2625 eligible men, 778 were operated on by open surgery and 1847 by robot-assisted surgery. Altogether, 2506 (95%) men were evaluated for short-term results and adverse events. Table 1 shows the baseline characteristics of the participants. Men operated on by the robot-assisted procedure more often had university or college education, a higher American Society of Anesthesiology Classification score, higher clinical tumour stages and longer total length of cancer in the prostate biopsies. Nerve-sparing surgery was more often done during robot-assisted procedures, even after adjustment for tumour characteristics. Limited lymph node dissection was significantly more common during open procedures, whereas extended lymph node dissection was more common in the robot-assisted group. The occurrence of diabetes, cardiovascular disease, pulmonary disease, kidney disease, previous abdominal surgery, previous transurethral resection of the prostate (TURP), and mental disorder was not statistically different between the two groups. As shown in Table 2, we investigated predictors of patient-reported readmission to hospital. Factors that significantly increased the risk of readmission included preoperative prostate-specific antigen level, lymph node dissection, prostate weight, clinical tumour stage, tumour stage of prostatectomy specimen, Gleason score on pathology specimen, and a history of mental disorder. No deaths occurred during the hospital stay (Table 3). Three patients died within 3 mo of surgery in the robotassisted laparoscopic group, and no one died in the open

radical prostatectomy group, which resulted in no statistically significant difference ( p = 0.56). A statistically significant difference between the groups was found for the amount of perioperative bleeding (185 vs 683 ml, p < 0.001) and length of hospital stay (3.3 vs 4.1 days, p < 0.001), in favour of the robot-assisted technique. Operating time was longer in the robot-assisted group compared to the open technique (103 vs 175 min, p < 0.001). Reoperation during initial hospital stay was significantly more frequent after open surgery (1.6%) versus the robot-assisted technique (0.7%) when adjusting for tumour factors and lymph node dissection, with OR 0.31 (CI 95% 0.11–0.90) (Table 3). The adverse events that occurred within 3 mo after the surgery are presented in five groups: infection, cardiovascular, surgical, gastrointestinal, and psychological (Table 4). During the study period, men operated on by the open technique were more likely to seek healthcare compared to men operated on by the robot-assisted technique, p = 0.03. It was significantly more common to seek healthcare for cardiovascular reasons in the open group after adjusting for nontumour and tumour-specific confounders (OR 0.63, CI 95% 0.42–0.94). Gastrointestinal and psychological reasons for seeking health care were significantly more frequent in the open group (OR 0.77, CI 95% 0.62–0.97 vs OR 0.76, CI 95% 0.60–0.96). The significance was sustained for psychological reasons after adjusting for nontumour and tumour-specific confounders (Table 4). Readmittance within 3 mo was not statistically different between the techniques (Table 5).

Please cite this article in press as: Wallerstedt A, et al. Short-term Results after Robot-assisted Laparoscopic Radical Prostatectomy Compared to Open Radical Prostatectomy. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.09.036

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Table 4 – Comparison between open and robot-assisted surgery concerning patient-reported adverse events 3 mo after surgery Adverse event

Infection Infection in the operation wound Pneumonia Urinary tract infection Cardiovascular Pulmonary embolism Hypertension Acute myocardial infarction Arrhythmia or other heart diseases Deep venous thrombosis Stroke Surgical

Open surgery, n (%)

Robot-assisted surgery, c n (%)

Unadjusted RR (CI 95%) Unadjusted OR (CI 95%)

121 (16.4)

309 (17.6)

42 (5.6)

59 (3.3)

1.08 (0.89–1.31) 1.09 (0.87–1.38) –

b

5 (0.7) 89 (11.9) 58 (7.9)

8 (0.5) 262 (14.8) 101 (5.8)

Adjusted for nontumour confounders d,e OR (CI 95%)

Adjusted for A + tumour-specific confounders f OR (CI 95%)

Adjusted for A + B + lymph node dissection g OR (CI 95%)

1.03 (0.81–1.32) –

0.91 (0.70–1.18) –

0.90 (0.69–1.18) –

6 (0.8) 34 (4.6) 1 (0.1)

5 (0.3) 70 (4.0) 2 (0.1)

– – 0.74 (0.54–1.01) 0.72 (0.52–1.01) – – –

12 (1.6)

24 (1.4)

–

–

–

–

14 (1.9) 0 (0.0) 187 (25.2)

4 (0.2) 0 (0.0) 392 (22.3)

– –

– –

– –

49 (6.6)

42 (2.4)

– – 0.88 (0.76–1.03) 0.85 (0.70–1.04) –

58 (7.8)

149 (8.4)

–

–

–

–

20 (2.7)

57 (3.2)

–

–

–

–

37 (5.0)

46 (2.6)

–

–

–

–

66 (8.8)

162 (9.2)

–

–

–

–

– – 0.81 0.77 – – – – 0.79 0.76 – –

– –

– –

– –

Pain in the operation wound Pain in the lower abdomen Pain in the upper abdomen Bleeding from the operation wound Bleeding from the urinary tract Inguinal hernia Catheter blockage Gastrointestinal

14 (1.9) 58 (7.8) 138 (18.7)

33 (1.9) 100 (5.7) 264 (15.1)

Nausea Impaired appetite Loose or frequent stools Constipation Psychological

17 37 48 84 122

35 64 99 138 228

Depressed mood Worry

a

(2.3) (5.0) (6.4) (11.2) (16.6)

92 (12.3) 94 (12.6)

(2.0) (3.6) (5.6) (7.8) (13.1)

156 (8.8) 187 (10.6)

(0.67–0.97) (0.62–0.97)

(0.64–0.97) (0.60–0.96)

– – 0.69 (0.47–1.00) – – –

0.84 (0.67–1.04) –

– – 0.63 (0.42–0.94) – – –

0.81 (0.64–1.03) –

– – 0.65 (0.43–1.00) – – –

0.85 (0.66–1.08) –

0.78 (0.61–1.01) – – – –

0.76 (0.60–1.01) – – – –

0.77 (0.58–1.03) – – – –

0.81 (0.62–1.06) – –

0.72 (0.53–0.96) – –

0.78 (0.58–1.06) – –

OR = odds ratio; RR = relative risk; CI = confidence interval. Total may not add up to 100 due to rounding of percentages. b Denotes retropubic radical prostatectomy. c Denotes robot-assisted laparoscopic radical prostatectomy. d Possible confounders to be used in adjustments for each outcome were selected as variables significantly associated ( p value <0.20) with the specific outcome. e Adjustment A. Readmission adjusted for: employment status preoperatively, International Prostate Symptom Score (IPSS), neurologic disease, mental disorder, kidney disease, and prostate weight. Infection adjusted for: previous transurethral resection of the prostate (TURP), IPSS, cardiovascular disease, pulmonary disease, neurologic disease, mental disorder, and prostate weight. Cardiovascular adjusted for: age at surgery, educational level, employment status preoperatively, body mass index (BMI), IPSS, diabetes, cardiovascular disease, pulmonary disease, mental disorder, prostate weight. Surgical adjusted for: employment status preoperatively, BMI, IPSS score, IPSS, cardiovascular disease, pulmonary disease, mental disorder, kidney disease, and prostate weight. Gastrointestinal adjusted for: age at surgery, educational level, employment status preoperatively, BMI, postoperative irradiation, coronary bypass surgery, smoking, IPSS, diabetes, cardiovascular disease, pulmonary disease, mental disorder, and prostate weight. Psychological adjusted for: age at surgery, educational level, employment status preoperatively, physical exercise, postoperative irradiation, coronary bypass surgery, smoking, IPSS, mental disorder, and prostate weight. f Adjustment B: Adjustment A + tumour factors (preoperative prostate-specific antigen level, clinical tumour stage, tumour stage of prostatectomy specimen, Gleason score on biopsy cores, and Gleason score pathology on specimen). g Adjustment C: Adjustment A + B + lymph node dissection. a

4.

Discussion

In this prospective controlled trial comparing robotassisted laparoscopic and open retropubic radical prostatectomy, we studied short-term results and adverse events as secondary endpoints defined by patient reports, thus

avoiding any bias that may arise when health-care personnel with technique preferences assess outcome [11,12]. The results show that men were more likely to seek health care within 3 mo after open surgery compared to robot-assisted surgery. Reoperation during initial hospital stay was statistically significantly more frequent after

Please cite this article in press as: Wallerstedt A, et al. Short-term Results after Robot-assisted Laparoscopic Radical Prostatectomy Compared to Open Radical Prostatectomy. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.09.036

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Table 5 – Comparison between open and robot-assisted surgery concerning patient-reported readmissions 3 mo after surgery Readmission and readmission causes

Open surgery, n (%)

b

Robot-assisted surgery, c n (%)

Readmission

57 (7.7)

163 (9.3)

Infection

10 (1.3)

37 (2.0)

UTI Deep infections Sepsis Wound infection Cardiovascular Pulmonary embolism DVT Chest pain AMI Surgical Catheter blockage and retention after catheter removal Anastomotic leakage Bleeding Lymphocele Abdominal pain Miscellaneous Operation hernia Other likely related to procedure Other not likely related to procedure Psychological Readmission leading to reoperation Readmission not leading to reoperation

7 2 0 1 9

(0.9) (0.3) (0.0) (0.1) (1.2)

21 7 7 2 5

(1.1) (0.4) (0.4) (0.1) (0.3)

5 2 1 1 15

(0.6) (0.3) (0.1) (0.1) (1.9)

3 0 1 1 55

(0.2) (0.0) (0.1) (0.1) (3.0)

7 (0.9)

19 (1.0)

1 1 4 2 4

14 9 3 10 25

(0.1) (0.1) (0.5) (0.3) (0.5)

(0.8) (0.5) (0.2) (0.5) (1.4)

0 (0.0) 1 (0.1)

4 (0.2) 13 (0.7)

2 (0.3)

6 (0.3)

1 (0.1) 13 (1.7)

2 (0.1) 29 (1.6)

36 (4.6)

116 (6.3)

Unadjusted RR (CI 95%) Unadjusted OR (CI 95%)

1.21 1.23 1.56 1.57 – – – – 0.23 0.23 – – – – 1.54 1.56 –

(0.91–1.62) (0.90–1.69) (0.78–3.12) (0.78–3.17)

(0.08–0.70) (0.08–0.69)

(0.88–2.72) (0.88–2.78)

– – – – 2.63 (0.92–7.54) 2.66 (0.92–7.65) – – – – 0.94 0.94 1.36 1.38

(0.49–1.80) (0.49–1.82) (0.94–1.95) (0.94–2.03)

a

Adjusted for nontumour confounders d,e OR (CI 95%)

Adjusted for A + tumour-specific confounders f OR (CI 95%)

Adjusted for A + B + lymph node dissection g OR (CI 95%)

1.26 (0.89–1.78)

1.21 (0.83–1.77)

1.39 (0.94–2.06)

1.61 (0.75–3.43) – – – –

1.44 (0.64–3.21) – – – –

1.68 (0.73–3.85) – – – –

0.32 (0.09–1.16) – – – –

0.28 (0.07–1.09) – – – –

0.32 (0.08–1.27) – – – –

1.54 (0.82–2.87) –

1.48 (0.75–2.92) –

1.77 (0.87–3.60) –

– – – – 2.34 (0.78–6.99) – –

– – – – 1.63 (0.54–4.96) – –

– – – – 1.44 (0.47–4.45) – –

–

–

–

–

–

–

1.07 (0.54–2.13)

1.22 (0.54–2.73)

1.44 (0.62–2.34)

1.45 (0.95–2.22)

1.34 (0.85–2.11)

1.56 (0.97–2.50)

OR = odds ratio; RR = relative risk; CI = confidence interval. Total may not add up to 100 due to rounding of percentages. b Denotes retropubic radical prostatectomy. c Denotes robot-assisted laparoscopic radical prostatectomy. d Possible confounders to be used in adjustments for each outcome were selected as variables significantly associated ( p value < 0.20) with the specific outcome. e Adjustment A. Infection adjusted for: age at surgery, employment status preoperatively, physical exercise, previously operated for inguinal hernia, previous transurethral resection of the prostate (TURP), International Prostate Symptom Score (IPSS), cardiovascular disease, mental disorder, kidney disease, and prostate weight. Cardiovascular adjusted for: IPSS, pulmonary disease, neurologic disease, and prostate weight. Surgical adjusted for: age at surgery, employment status preoperatively, coronary bypass surgery, IPSS, mental disorder, and prostate weight. Miscellaneous adjusted for: age at surgery, postoperative irradiation, previously operated for inguinal hernia, IPSS, kidney disease, and prostate weight. Readmission leading to reoperation adjusted for: age at surgery, postoperative irradiation, and prostate weight. Readmission not leading to reoperation adjusted for: employment status preoperatively, previously operated for inguinal hernia, previous TURP, IPSS, mental disorder, and prostate weight. f Adjustment B: Adjustment A + tumour factors (preoperative prostate-specific antigen level, clinical tumour stage, tumour stage of prostatectomy specimen, Gleason score on biopsy cores, and Gleason score pathology on specimen). g Adjustment C: Adjustment A + B + lymph node dissection. a

open surgery when adjusting for tumour factors and lymph node dissection. The robot-assisted technique also improved short-term outcomes such as perioperative bleeding and length of hospital stay, but resulted in longer operating time compared to open surgery. However, there was no statistically significant difference in readmittance rate between the groups within 3 mo after the operation. It was more common to seek health care after open surgery compared to robot-assisted surgery. The data

specifically show that it was more common to seek health care for cardiovascular reasons in the open group. The difference was statistically significant after adjusting for nontumour and tumour-specific confounders. Patientreported outcomes showed higher absolute percentages of thromboembolic events, deep venous thrombosis and pulmonary embolism in the open radical prostatectomy group compared to the robot-assisted surgery group (Table 4). Similar results have been presented by van Hemelrijck et al [13] in a large retrospective case-control

Please cite this article in press as: Wallerstedt A, et al. Short-term Results after Robot-assisted Laparoscopic Radical Prostatectomy Compared to Open Radical Prostatectomy. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.09.036

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Reported to the study register Start date: September 1, 2008 End date: November 7, 2011

(n = 4003)

No informed consent (n = 21)

Withdrawn consent; not understanding Swedish; physical, psychosocial and practical reasons (n = 281) Surgeon having performed <100 operations (n = 980) No cancer in surgical specimen (n = 2) No operation performed (n = 26)

>75 yr ≥20 ng/ml prostate-specific antigen (PSA) >T3 tumor stage Metastatic disease

Evaluable (n = 2625)

Open radical prostatectomy (n = 778)

Robot-assisted laparoscopic radical prostatectomy (n = 1847)

Response rates Preoperative clinical report form 98%

Preoperative clinical report form 100%

Surgical clinical report form 98%

Surgical clinical report form 100%

Postoperative care clinical report form 98%

Postoperative care clinical report form 100%

6–12-wk clinical report form 98%

6–12-week clinical report form 99%

Preoperative patient questionnaire 89%

Preoperative patient questionnaire 88%

3-mo patient questionnaire 96%

3-mo patient questionnaire 96%

Analysed (n = 745)

Analysed (n = 1761)

Fig. 1 – Flow chart for the analysis of short-term results of the LAPPRO trial. Numbers may not total correctly, because the same individual may have fulfilled more than one exclusion criteria.

study. A theory for the reason for more thromboembolic events in the open group is that the extraperitoneal approach leaves a smaller space than the robot-assisted approach if haematomas or lymphoceles occur, and this could result in high pressure on the femoral veins and lead to deep venous thrombosis, which also is a common cause of pulmonary embolism. However, Gandaglia et al [14] recently reported in a study of 5915 men that patients treated with open and robot-assisted techniques had similar risk of overall postoperative complications, and that robot-assisted surgery led to a higher risk of genitourinary and miscellaneous medical complications.

Patients operated on by open surgery reported somewhat more contact with the health-care system for gastrointestinal symptoms compared to those operated on by robot-assisted surgery, although this was not statistically significantly different (Table 4). Most trials of laparoscopic versus open abdominal surgery have found that gastrointestinal symptoms (ie, nausea, impaired appetite, or changes in stools) occur for a longer period of time after open surgery [15,16]. However, Schroeck et al [17] reported no difference concerning bowel function between a robot-assisted laparoscopic group and an open retropubic radical prostatectomy group. Results also show

Please cite this article in press as: Wallerstedt A, et al. Short-term Results after Robot-assisted Laparoscopic Radical Prostatectomy Compared to Open Radical Prostatectomy. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.09.036

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that more men sought care due to psychological symptoms after open surgery compared to the robot-assisted approach (Table 4). In Sweden and the USA, men have an increased risk of suicide in the year after a prostate cancer diagnosis [18–20]. Men with newly diagnosed prostate cancer seek psychiatric health care more often than cancerfree men [21]. Our study, finding a difference in the prevalence of psychological symptoms between surgical techniques, indicates that predictors other than the existential challenge of the cancer diagnosis need to be explored in relation to psychiatric morbidity among prostate cancer patients. Reoperation during hospital stay was significantly more frequent after open surgery compared to robot-assisted surgery when adjusting for tumour factors and lymph node dissection (Table 3). Similarly, in a meta-analysis by Tewari et al [1], reoperation rates were significantly higher in the open surgery group compared to the robot-assisted surgery group; however, after propensity adjustments, there was no significant difference. The reduced risk for reoperation with the robot-assisted technique might be explained by less tissue trauma and/or less perioperative bleeding, which has previously been shown in other types of surgery to lead to a lower degree of inflammatory response [22]. As others have previously shown, our results indicate that robot-assisted laparoscopic radical prostatectomy seems to be advantageous over open surgery in terms of perioperative bleeding and length of hospital stay (Table 3). These results are similar to data in a newly conducted meta-analysis and in a registry-based study [1,23,24]. The reason for less bleeding in the robot-assisted technique is usually explained by the pneumoperitoneum, which gives a high pressure in the abdomen during surgery and minimises perioperative bleeding. The positioning of the patient in the Trendelenbourg position, which reduces venous blood pressure, is another explanation which may have a positive effect on perioperative bleeding. The shorter operating time associated with the open technique, as reported in this study, was also confirmed by other authors [25,26]. There was no statistically significant difference in the overall readmission rate within 3 mo after surgery; however, the overall readmission rate was slightly more common after robot-assisted surgery compared to open surgery (9.3% vs 7.7%; Table 5). These data confirm the report of Gandaglia et al [14], who reported in 2014 that patients undergoing open and robot-assisted surgery had similar odds of readmission within 90 d after surgery. Although there was no statistically significant difference between the groups concerning causes for patient-reported readmissions in our study, the data show that it was more common to be readmitted for cardiovascular reasons after open surgery, but this significance disappeared after adjustments. In a national registry-based study, Chung et al [27] found higher rates of readmission after open retropubic radical prostatectomy compared to the robot-assisted approach. The strengths of our study include the prospective, controlled design, size, short inclusion period, high response rate, use of validated measures, and the neutral third-party approach. We made sure to obtain accurate

9

information of known and suspected risk factors for adjustment. The modest changes after adjustments indicate that the residual confounding is small, if any. Since health-care professionals in the respective centres were not blinded, either as assessors or as reporters of surgeryinduced problems, the reports could be influenced by their enthusiasm for the surgical technique used in their centre. The ‘‘I want to please my surgeon’’ attitude among patients, on the other hand, is possibly related more to the surgeon than the surgical technique [28,29]. A limitation of the study, apart from the nonrandomised design, is the lack of a standardised tool for the assessment of the adverse events. At the time when the study was designed and initiated, the Clavien-Dindo system of systematic grading of adverse events after surgical procedures, which requires data on the management of the complications, was not generally recognised and, therefore, was not included in the clinical report forms [30]. Another limitation is the lack of a standardised postoperative clinical pathway in the study. Each of the 14 centres used their own best practice, and this might influence the hospital stay data. 5.

Conclusions

Our study shows that short-term outcomes may be influenced by the surgical technique used for radical prostatectomy. However, evaluating the pros and cons of robot-assisted laparoscopic radical prostatectomy as compared with open surgery involves weighing together a large number of incommensurable short- and long-term outcomes, including economic consequences and cure rates. Author contributions: Anna Wallerstedt had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Wallerstedt, Tyritzis, Carlsson, Hugosson, Bjartell, Wildera¨ng, Wiklund, Steineck, Haglind. Acquisition of data: Wallerstedt, Tyritzis, Thorsteinsdottir, Carlsson, Stranne, Gustafsson, Hugosson, Bjartell, Wildera¨ng, Wiklund, Steineck, Haglind. Analysis and interpretation of data: Wallerstedt, Tyritzis, Thorsteinsdottir, Carlsson, Stranne, Gustafsson, Hugosson, Bjartell, Wildera¨ng, Wiklund, Steineck, Haglind Drafting of the manuscript: Wallerstedt, Hugosson, Bjartell, Wiklund, Steineck, Haglind. Critical revision of the manuscript for important intellectual content: Wallerstedt, Tyritzis, Thorsteinsdottir, Carlsson, Stranne, Gustafsson, Hugosson, Bjartell, Wildera¨ng, Wiklund, Steineck, Haglind. Statistical analysis: Wallerstedt, Wildera¨ng Obtaining funding: Wiklund, Steineck, Haglind Administrative, technical, or material support: Wiklund, Steineck, Haglind. Supervision: Wiklund, Steineck, Haglind. Other (specify): None. Financial disclosures: Anna Wallerstedt certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None.

Please cite this article in press as: Wallerstedt A, et al. Short-term Results after Robot-assisted Laparoscopic Radical Prostatectomy Compared to Open Radical Prostatectomy. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.09.036

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Funding/Support and role of the sponsor: None.

[8] Steineck G, Helgesen F, Adolfsson J, et al. Quality of life after radical prostatectomy or watchful waiting. N Engl J Med 2002;347:790–6.

Acknowledgment statement: The HRQL study was supported by research grants from the Swedish Cancer Foundation (2010/593), Region Va¨stra Go¨taland, Sahlgrenska University Hospital (ALF grants 138751 and 146201, agreement concerning research and education of doctors), Swedish Research Council, Mrs. Mary von Sydow Foundation, Anna and Edvin Berger foundation, and EUSP fellowship grant to Dr. Stavros I. Tyritzis. We thank Dr. Sven Grundtman for including patients.

[9] Steineck G, Bergmark K, Henningsohn L, al-Abany M, Dickman PW, Helgason A. Symptom documentation in cancer survivors as a basis for therapy modifications. Acta Oncol 2002;41:244–52. [10] R Development Core Team. A language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2005. [11] Steinsvik EA, Fossa SD, Axcrona K, Fransson P, Widmark A, Dahl AA. Do perceptions of adverse events differ between patients and

Appendix A. Members of the LAPPRO steering committee

physicians? Findings from a randomized, controlled trial of radical treatment for prostate cancer. J Urol 2010;184:525–31. [12] Sonn GA, Sadetsky N, Presti JC, Litwin MS. Differing perceptions of

Bo Anderberg, Department of Surgery, St Go¨rans Hospital, Stockholm, Sweden; Ingela Bjo¨rholt, Nordic Health Economics, Go¨teborg, Sweden; Thomas Jiborn, Department of Urology, Ska˚ne University Hospital, Lund University, Lund, Sweden; Jan-Erik Damber, Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Go¨teborg, Sweden; Ali Khatami, Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Go¨teborg, Sweden; Mikael Wulkner-Sylme´, Department of Urology, Varberg Hospital, Varberg, Sweden; Christer Edlund, Department of Surgery, Kungsbacka Hospital, Kungsbacka, Sweden; Erik Pileblad, Capio Lundby Hospital, Gothenburg, Sweden; Hans Boman, Department of Surgery, Alingsa˚s Hospital, Alingsa˚s, Sweden; Ola Bratt, Department of Urology, Helsingborg Hospital, Helsingborg, Sweden; Ulrika Westlund, Department of Urology, So¨dersjukhuset, Stockholm, Sweden

quality of life in patients with prostate cancer and their doctors. J Urol 2013;189(1 Suppl):S59–65. [13] Van Hemelrijck M, Garmo H, Holmberg L, Stattin P, Adolfsson J. Multiple events of fractures and cardiovascular and thromboembolic disease following prostate cancer diagnosis: results from the population-based PCBaSe Sweden. Eur Urol 2012;61: 690–700. [14] Gandaglia G, Sammon JD, Chang SL, et al. Comparative effectiveness of robot-assisted and open radical prostatectomy in the postdissemination era. J Clin Oncol 2014;32:1419–26. [15] Veldkamp R, Kuhry E, Hop WC, et al. Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial. Lancet Oncol 2005;6:477–84. [16] van der Pas MH, Haglind E, Cuesta MA, et al. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol 2013;14:210–8. [17] Schroeck FR, Krupski TL, Sun L, et al. Satisfaction and regret after open retropubic or robot-assisted laparoscopic radical prostatectomy. Eur Urol 2008;54:785–93. [18] Bill-Axelson A, Garmo H, Lambe M, et al. Suicide risk in men with prostate-specific antigen-detected early prostate cancer: a nation-

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Please cite this article in press as: Wallerstedt A, et al. Short-term Results after Robot-assisted Laparoscopic Radical Prostatectomy Compared to Open Radical Prostatectomy. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.09.036