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International Journal of Urology (2015) 22, 469–474

doi: 10.1111/iju.12711

Original Article: Clinical Investigation

Comparative investigation on clinical outcomes of robot-assisted radical prostatectomy between experienced open prostatic surgeons and novice open surgeons in a laparoscopically naïve center with a limited caseload Makoto Sumitomo, Kent Kanao, Yoshiharu Kato, Takahiko Yoshizawa, Masahito Watanabe, Kenji Zennami and Kogenta Nakamura Department of Urology, Aichi Medical University School of Medicine, Nagakute, Aichi, Japan Abbreviations & Acronyms BCR = biochemical recurrence DVC = dorsal vein complex EBL = external blood loss G1 = group 1 G2 = group 2 G3 = group 3 IIEF-5 = International Index of Erectile Function-5 IQR = interquartile range LRP = laparoscopic radical prostatectomy NSS = nerve-sparing surgeries ORP = open radical prostatectomy PBCN = positive biopsy core number POM = post-operative month PSA = prostate-specific antigen PSM = positive surgical margins RARP = robot-assisted radical prostatectomy Correspondence: Makoto Sumitomo M.D., Department of Urology, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi 480-1195, Japan. Email: [email protected] Received 28 August 2014; accepted 14 December 2014. Online publication 26 February 2015

© 2015 The Japanese Urological Association

Objectives: To compare perioperative, oncological and functional outcomes of robotassisted radical prostatectomy between experienced and novice open radical prostatectomy surgeons in a laparoscopically naïve center with a limited caseload. Methods: Six surgeons carried out robot-assisted radical prostatectomy in 154 patients, which were divided into the following three groups: group 1 (n = 90), including patients operated on by a surgeon with experience in both open radical prostatectomy and robot-assisted radical prostatectomy; group 2 (n = 36), including patients operated on by two surgeons with experience in open radical prostatectomy only; and group 3 (n = 28), including patients operated on by three surgeons with limited experience in both open radical prostatectomy or robot-assisted radical prostatectomy. Results: Groups 2 and 3 did not differ significantly in their median values of external blood loss (P = 0.165) or console time (P = 0.103). Positive surgical margin rates for pT2 patients were also similar in these two groups: 21.2% (7/33) in group 2 and 22.7% (5/22) in group 3 (P = 0.894). Kaplan–Meier analysis showed that 12 months after robot-assisted radical prostatectomy the prostate-specific antigen-free rate for pT2 patients was 96.0% in group 2 and 100% in group 3, but the pad-free continence rate was just 91.0% in group 1, 88.0% in group 2 and 75.5% in group 3 (group 1 vs group 3, P = 0.037; group 2 vs group 3, P = 0.239). The major complication rate after robot-assisted radical prostatectomy was 3.3% (3/90) in group 1, 11.1% (4/36) in group 2 and 17.9% (5/28) in group 3 (group 1 vs group 3, P = 0.008; group 2 vs group 3; P = 0.441). Conclusions: Robot-assisted radical prostatectomy offers satisfactory postoperative outcomes even when carried out by surgeons with limited experience in open radical prostatectomy.

Key words:

clinical outcomes, learning curve, novice open radical prostatectomy surgeon, parallel learning, robot-assisted radical prostatectomy.

Introduction RARP is a rapidly evolving technique becoming widely used as an alternative to ORP and LRP.1 Robotic-assisted technology has generated much enthusiasm among urologists, particularly novice or non-laparoscopically trained surgeons who can now transition to minimally invasive treatments.2 One concern, however, is the large number of young surgeons who have learned operation procedures and gained anatomical knowledge from well-edited video records, but have little or no ORP or LRP experience.2 Ahlering et al. reported that a laparoscopically naïve yet experienced open surgeon using a robotic interface successfully transferred open surgical skills to a laparoscopic environment within 8–12 cases, suggesting that limited LRP skills do not prevent the use of robotic technology if surgeons have extensive ORP skills.3 It did not, however, prove that ORP skills are required for using robotic technology. Unfortunately, there are no studies investigating whether limited ORP skills might negatively affect the RARP learning curve and outcomes. At the Aichi Medical University Hospital, Aichi, Japan, several young urologists have had no chance to carry out ORP as a main surgeon before starting RARP, and two experienced surgeons had carried out 20–30 ORP annually for a few years before starting RARP. We thus happened to have two groups learning RARP: one with little or no ORP experience and 469

M SUMITOMO ET AL.

the other comparatively well experienced in ORP. In the present study, we compared perioperative, oncological and functional RARP outcomes between those groups in a laparoscopically naïve center with a limited caseload.

Methods A total of 154 consecutive patients underwent RARP between May 2012 and March 2014. RARP was carried out by six surgeons using the da Vinci S Surgical System (Intuitive Surgical, Sunnyvale, CA, USA). All patients were treated after obtaining informed consent and after approval by the ethical committee of Aichi Medical University. Patients were categorized into the three groups shown in Table 1: G1, 90 patients operated on by an experienced open prostatic surgeon A (MS) whose RARP experience was more than 30 cases; G2, 36 patients operated on by two experienced open prostatic surgeons B (KN) and C (KK) whose RARP experiences were each less than 30 cases; and G3, 28 patients operated on by three novice-ORP and novice-robotic surgeons D (YK), E (TY) and F (KZ). No surgeons had LRP experience, but all surgeons had RARP certificates obtained after over 20 h of dry-lab training followed by training on animals. The RARP procedure was carried out using a transperitoneal approach described elsewhere and was divided into several steps following the concept of parallel learning as proposed previously.3–6 The surgical steps are the following: bladder take down, incision of the endopelvic fascia, bladder neck dissection, dissection of the vasa and seminal vesicles, posterior dissection, division of the vascular pedicles with or without sparing the neurovascular bundles, apical dissection of the prostate with mattress suturing of the DVC and division of the urethra, lymph node dissection, application of the Rocco stitch, and vesicourethral anastomosis. Ligation of the DVC before bladder neck dissection was used in the initial cases of surgeons A and B. We used several simple rules for training RARP surgeons. First, each trainee must serve as a patient-side assistant in at least 10 RARP carried out by surgeon A. Next, the trainees must receive at least five preoperative video training sessions and engage in five postoperative feedback discussions after watching videos of operations in which they assisted. Finally, when the trainees can, in a RARP with surgeon A as the main surgeon, they carry out the bladder take down step within 30 min and the vesicourethral anastomosis step within 30 min, and are certified as RARP operators. In both G2 and G3, during the initial phase of RARP procedures carried out by any of the surgeons, intraoperative mentoring

was mainly carried out using chalk board instruction by surgeon A. NSS were used only if desired by the patient after the patient had been informed of the benefits and risks. On the seventh postoperative day, cystography with anteroposterior and lateral views was carried out to evaluate the anastomotic tightness. Patient baseline characteristics, perioperative and postoperative outcomes, and complications were evaluated. End-points were operating data (EBL, console time), oncological data (PSM, PSA), perioperative complications according to Clavien–Dindo classification and urinary continence. The urinary incontinence rate was defined as the incontinent urinary volume divided by total voided urinary volume during admission. Urinary continence after discharge was defined as no leakage at all. IIEF-5 questionnaires were used to evaluate preoperative and postoperative potency without use of phosphodiesterase type 5 inhibitors. BCR was defined as two consecutive PSA measurements >0.2 ng/mL. The statistical significance of differences between groups was evaluated using the Mann–Whitney U-test, χ 2-test and Kaplan–Meier analysis. Statistical significance was defined as P < 0.05.

Results Operator profiles are listed in Table 1. One of the surgeons for each group had been certified in laparoscopic surgery by the Japanese Society of Endourology. Two of the surgeons for G3 had much more experience as RARP assistants than the other two. Preoperative characteristics, such as age, body mass index, PBCN, PSA, Gleason score and clinical T stage, are listed in Table 2 along with the weight of the removed prostate. Statistical analyses showed that G3 was comparable with other groups for all variables but PBCN. Surgical data on operating times are also listed in Table 2. The median operating time was 238 min (range 184–444 min) in G1, 326 min (range 259–440 min) in G2 and 336 min (range 257–461 min) in G3. Operating times differed significantly between G2 and G3 only for the posterior dissection and division of the vascular pedicles (34 min vs 43 min; P < 0.001), and for apical dissection with DVC suturing and division of the urethra (19 min vs 26 min; P = 0.001), whereas the operating times for all surgical steps differed significantly between G1 and G3. We further compared the learning curves for each surgical step between the G2 and G3 surgeons. As shown in Figure 1, steep learning curves for the whole console time (Fig. 1a), and the time for apical dissection and division of the urethra (Fig. 1d) were observed for both groups. In contrast, there were no learning curve differences

Table 1 Operator profiles Operator (group)

Years as urologist

RARP operator experience

RARP assistant experience

Certificate of laparoscopic surgery

ORP operator experience

ORP assistant experience

A (G1) B (G2) C (G2) D (G3) E (G3) F (G3)

23 17 16 8 7 10

90 20 16 11 10 7

2 12 14 109 86 23

yes yes no no no yes

>200 50–100 50–100 0 0 8

>100 50–100 50–100

Comparative investigation on clinical outcomes of robot-assisted radical prostatectomy between experienced open prostatic surgeons and novice open surgeons in a laparoscopically naïve center with a limited caseload.

To compare perioperative, oncological and functional outcomes of robot-assisted radical prostatectomy between experienced and novice open radical pros...
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