Intra- and Peri-Operative Outcomes Comparing Radical Retropubic and Laparoscopic Radical Prostatectomy: Results from a Prospective, Randomised, Single-Surgeon Study

Intra- and Peri-Operative Outcomes Comparing Radical Retropubic and Laparoscopic Radical Prostatectomy: Results from a Prospective, Randomised, Single-Surgeon Study

european urology 50 (2006) 98–104 available at www.sciencedirect.com journal homepage: www.europeanurology.com Laparoscopy Intra- and Peri-Operativ...

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european urology 50 (2006) 98–104

available at www.sciencedirect.com journal homepage: www.europeanurology.com

Laparoscopy

Intra- and Peri-Operative Outcomes Comparing Radical Retropubic and Laparoscopic Radical Prostatectomy: Results from a Prospective, Randomised, Single-Surgeon Study Giorgio Guazzoni, Andrea Cestari, Richard Naspro *, Matteo Riva, Antonia Centemero, Matteo Zanoni, Lorenzo Rigatti, Patrizio Rigatti Department of Urology, University Vita-Salute San Raffaele, H. San Raffaele-Turro, Milan, Italy

Article info

Abstract

Article history: Accepted February 21, 2006 Published online ahead of print on March 9, 2006

Objectives: To prospectively compare intra- and peri-operative outcomes of open radical retropubic prostatectomy (RRP) and laparoscopic prostatectomy (LRP) by a single surgeon. Patients and methods: One-hundred-twenty, consecutive, age-matched patients diagnosed with clinically localized prostate cancer were eligible for surgery. Sixty patients underwent RRP and 60, LRP. Intra- and perioperative parameters, pathologic findings and early complications were recorded. A validated visual analogue scale was used to assess pain in the recovery room, 3 h after the operation and on post-operative days 1, 2 and 3. A cystogram was performed on post-operative day 5. Results: Operating time was significantly shorter in the RRP group versus the LRP group (mean  SD, 170  34. 2 vs 235  49.9 min, p < 0.001). Blood loss was significantly less in the LRP group versus the RRP group (mean  SD, 853.3  485 vs 257.3  177 ml, p < 0.001), but no patient in either group underwent early re-intervention for bleeding. The RRP group showed a trend for higher use of analgesia. A watertight anastomosis was shown at cystourethrography and the catheter removed in 86% and 66% of LRP and RRP patients, respectively. The overall percentage of post-operative complications and positive margins were comparable. Conclusion: Laparoscopic prostatectomy is an attractive alternative to open prostatectomy, offering the advantages of reduced blood loss and safe early catheter removal. Furthermore, the laparoscopic procedure proved to be safe oncologically. Long-term follow-up is required to compare functional results in terms of continence and potency.

Keywords: Prostate cancer Laparoscopy Radical prostatectomy

# 2006 European Association of Urology. Published by Elsevier B.V. All rights reserved.

* Corresponding author. Tel. +39 0226 437286. E-mail address: [email protected] (R. Naspro). 0302-2838/$ – see back matter # 2006 European Association of Urology. Published by Elsevier B.V. All rights reserved.

doi:10.1016/j.eururo.2006.02.051

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1.

Introduction

Open radical retropubic prostatectomy (RRP) is widely considered the treatment of choice for localized prostate cancer [1,2]. New developments in anesthesia, surgical technique, overall medical management and good patient selection have improved the outcomes of this procedure [3–5]. After the first feasibility report by Schuessler [6] in 1997 and the standardization of the laparoscopic prostatectomy (LRP) technique by Guillonneau et al. [7] in 1999, a progressively growing interest has risen in the urologic community for LRP. Since then, the advantages and pitfalls of this minimally invasive approach have been increasingly reported in the literature by different authors [8]. Short hospital stay, reduced catheterisation time, better pain control and fast return to everyday activities seem the most encouraging improvements that arise [9]. Therefore, general interest is surely focused nowadays on the comparison between LRP and RRP. However, the interpretation of the data presented in the literature continues to be debated and has yet to be clarified. This prospective, randomized, single-surgeon trial compares intra- and peri-operative outcomes between RRP and LRP with the endpoint to evaluate potential advantages of the laparoscopic approach. 2.

Patients and methods

At our department, 120 consecutive and age-matched patients who were diagnosed with clinically localized prostate cancer were considered eligible for surgical treatment and included in this study. Using a computer-generated randomisation table, we assigned 60 patients to undergo RRP

(group 1) and 60 to undergo LRP (group 2). The following inclusion criteria were considered: age <70 years, clinically organ-confined disease (cT1-cT2), total serum prostate specific antigen (PSA) <20 ng/dl, Gleason score 7. Exclusion criteria were previous hormone blockade therapy or any previous prostatic, bladder neck, urethral or pelvic surgery and total prostate volume 60 ml. At baseline, no patient had an indwelling catheter. All patients were evaluated preoperatively by digital rectal examination (DRE), total serum PSA, Gleason score at biopsies, trans-rectal prostatic ultrasound (TRUS), abdominal computed tomography scan and bone scan. Patient characteristics are reported in Table 1. For the purpose of the study, all patients banked two units (IU) of autologous blood before surgery, each unit containing an average volume of 400 ml. Radical retropubic prostatectomy was performed in all patients under general anesthesia. The anatomic technique described by Walsh [2] was applied whenever possible. A xenon head light and 2.5 magnification loops were used. The urethro-vesical anastomosis was performed with seven 3-0 Monocryl (Ethicon) interrupted sutures, with a 5/8 needle. Laparoscopic radical prostatectomy was performed via the trans-peritoneal route according to the Montsouris technique [10]. The urethro-vesical anastomosis was performed with eight to ten, 3-0 (Polysorb-Tyco) interrupted sutures performed intracorporeally, after insertion of a metal bougie to expose the urethral stump [11]. In both groups, limited pelvic lymphadenectomy was performed when total serum PSA level was 10 ng/ml and/or Gleason score = 7 [12]. In both groups, mono or bilateral nerve-sparing procedure was performed whenever possible, according to pre-operative parameters such as age, clinical stage and pre-operative potency recorded by the International Index of Erectile Function (IIEF) questionnaire and penile power Doppler ultrasound evaluation (data not presented). Surgical time was considered real time of theatre occupation (total time in the operating room from entry to exit). All procedures in both groups were performed by a senior urologist (G.G.) who had been performing radical retropubic prostatectomies for the previous 15 years and had

Table 1 – Patient characteristics (mean W SD) RRP

LRP

p value

No. of patients Mean age (yr) Pre-op total PSA (ng/ml) TRUS volume (g)

60 62.9  7.4 6.5  3 40  13

60 62.29  8.2 6.9  2.9 39.1  18

0.21 0.55 0.32

Clinical stage cT1 cT2

50 (83.3%) 10 (16.6%)

45 (75%) 15 (25%)

0.34 0.18

Pre-op pathology (Gleason score) 2+2 2+3 3+2 3+3 3+4 4+3

2 10 8 29 8 3

1 6 4 31 13 5

LRP = laparoscopic prostatectomy; pre-op = pre-operative; PSA = prostate specific antigen; RRP = radical retropubic prostatectomy; TRUS = transrectal prostatic ultrasound.

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started his general laparoscopic experience 12 years before the study and, in particular, laparoscopic radical prostatectomies in 1999 (i.e., >150 procedures to date) [13,14]. Operating room time was recorded in the RRP and LRP groups. Estimated intra-operative blood loss and autologous or homologous transfusions were assessed accurately. Pain was assessed with the use of a validated 10-point visual analogue scale (VAS) for pain (0 = no pain, 10 = worst possible pain) when the patient was admitted in the recovery room, 3 h after the operation and on post-operative days (PODs) 1, 2 and 3. Standard analgesic protocol included administration of tramadole 1 mg/kg and ketoprophene 100 mg 30 min before the end of the operation and tramadole 200 mg + ketoprophene 200 mg diluted in 500 ml of saline solution infused at 30 ml/h starting from admission to the recovery room until 8.00 AM on POD 1. If any further analgesia was requested by the patient (VAS > 3) during the day of the operation, 100 mg of pethidine was administered intravenously every 8 h. If pain was present after POD 1 (VAS > 3), 100 mg ketoprophene could be administered intramuscularly a maximum of three times in 24 h. The need for any further analgesia was recorded accurately. On POD 1, all patients were assisted in mobilization and received a liquid diet, whilst on POD 2 they received a solid diet. First flatus and assisted or independent mobilization also were recorded. On POD 5, all patients underwent a cystogram with the catheter balloon being deflated and 150 cc of liquid injected. The catheter was thereafter removed if no extravasation was recorded, and patients were discharged 24 h later. If extravasation was present, the catheter was left in place and after 7 additional days on an outpatient basis. Catheterisation time, hospital stay and peri-operative complications were recorded. Care was taken to identify positive surgical margins, which were considered as any ink on the specimen section regardless of pathologic stage. The study was approved by our ethics committee; all patients signed an informed consent form. All data were analysed statistically with the Student t-test for paired data and are presented as mean  SD. For all statistical comparisons, significance was defined as a p value <0.05.

3.

Results

The two groups were comparable in terms of age, pre-operative total serum PSA, prostate volumes, biopsy Gleason score and clinical stage (Table 1).

Intra- and peri-operative results in both groups are listed in Table 2. The number of patients who underwent a nerve-sparing procedure (mono or bilateral) was similar in both groups. Time in the operating room was significantly shorter in the open surgery group, while blood loss was significantly less in the laparoscopic group. Five patients in the open group received homologous blood transfusion, compared with none in the laparoscopic group ( p < 0.001) Autologous transfusion was also significantly higher in the open group (45% vs 13.3%, p < 0.001). No laparoscopic procedure was converted to open surgery in this series, and no patient underwent early re-intervention in either group. During POD 1, 15% and 7% of patients required two intramuscular administrations of pethidine 100 mg, in groups 1 and 2, respectively ( p = 0.03). On POD 2, 16% of patients from the RRP group required one further administration of 100 mg ketoprophene intramuscularly, compared with 6% of the LRP group ( p = not significant). On POD 3, only one patient from the RRP group required analgesia. At discharge, no patient from either group required further analgesia. However, two (3.3%) patients in the open group referred pain at the incision. Patients treated by LRP showed a trend towards a reduced need for extra analgesic coverage, and a statistically significant difference was noticed in terms of pain between the two groups on POD 1 (Table 3). All patients were assisted in mobilization on POD 1. Fifty percent of patients of group 1 and 46% of group 2 had a transient episode of orthostatic hypotension once mobilized. Of these patients 11 and 5 patients had to interrupt mobilization on POD 1 in groups 1 and 2, respectively, because of orthostatic hypotension at mobilization. Early post-operative results are summarised in Table 4. Cystogram performed on POD 5 demonstrated no urine leakage, therefore allowing safe catheter removal in 86.6% of patients of the LRP group, compared with 66.6% of the open group ( p < 0.001). One case of rectal injury was reported in the LRP group, which was repaired with interrupted

Table 2 – Intra- and peri-operative data

Total operative time (min) Pelvic lymphadenectomy Bilateral nerve sparing Monolateral nerve sparing Blood loss (cc) Homologous transfusion Autologous transfusion (no)

RRP

LRP

p value

170  34.2 27 (45%) 31 (51.6%) 8 (13.3%) 853.3  485 5 (9%) 27 (45%)

235  49.9 24 (40%) 25 (41.6%) 11 (18.3%) 257.3  177 0 8 (13.3%)

<0.001 <0.34 <0.02 <0.15 <0.001 <0.001 <0.001

LRP = laparoscopic prostatectomy; RRP = radical retropubic prostatectomy.

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Table 3 – Post-operative pain measured by VAS in the two groups (RRP vs LRP) (mean W SD)

RRP group LRP group p value

RR

3 ha

POD1

POD2

POD3

1.92  1.08 1.88  1.31 0.89

2.75  1.99 1.92  1,46 0.09

2.65  1.44 1.7  1.45 0.031

1.96  1.2 1.61  0.9 0.250

1.53  1.13 1.03  0.82 0.073

LRP = laparoscopic prostatectomy; POD = post-operative day; RR = recovery room; RRP = radical retropubic prostatectomy; VAS = visual analogue scale. a 3 h after the operation.

Table 4 – Early post-operative results POD

RRP 1

First flatus (%) Mobilization (%) Free ambulation (%) Oral solid intake (%) 5-day catheterization Discharged on POD 6 (with or without catheter)

11 49 6 – 40 52

LRP

2

(18) (82) (10)

45 11 54 58

3

(75) (18) (90) (96)

(66.6%) (86.6%)

4 (7) – – 2 (4)

1 21 55 14 – 52 54

(35) (92) (23) (86.6%) (90%)

2 37 5 46 55

(62) (8) (77) (92)

p value 3 2 (3) – – 5 (8) <0.001 0.011

LRP = laparoscopic prostatectomy; POD = post-operative day; RRP = radical retropubic prostatectomy.

sutures intra-operatively; ultimately the patient had an uneventful outcome. With regard to early adverse events, anastomotic leakage was demonstrated at cystogram in 20 patients from the RRP group (33.3%), compared with 8 (12%) from the LRP group. One patient per group suffered acute urinary retention after removal of the catheter ( p = 0.39). Fifty-two and 54 patients were discharged on POD 6 with or without catheter, in the RRP and LRP groups, respectively. Delayed discharge was due to fever (RRP = 3 patients vs LRP = 1 patient), persistent lymphorrhea (RRP = 5 patients vs LRP = 4 patients) and rectal damage (LRP = 1). There were no differences in terms of final pathology, and the rate of positive surgical margins was similar in the two groups (Table 5).

Table 5 – Pathologic findings RRP (60) pT2 pT3 a b

44 16 14 2

(73.3%) (26.6%) (23.3%) (3.33%)

Positive margins pT2 8 (18.25%) pT3 5 (31.24%) Total 13 (21.6%)

LRP (60) 45 15 12 3

p value

(75%) (25%) (20%) (5%)

11 (24.4%) 5 (33.3%) 16 (26%)

LRP = laparoscopic prostatectomy; RRP = radical retropubic prostatectomy.

0.1 0.1

0.39 0.88 0.28

4.

Discussion

Radical retropubic prostatectomy is currently the gold standard treatment for localized prostate cancer [15]. With regard to RRP, functional and oncologic results are reproducible, and the technique has certainly passed the test of time. On the contrary, although showing promising results, the laparoscopic approach is a very young technique (i.e., 7 years) and still under development. Furthermore, general results achieved with open surgery have been improving continuously throughout the series published in the literature [16]. Moreover, the peculiar mini-invasiveness, typical of LRP, has led most surgeons to inevitably modify their open surgery technique, trying to keep up with the laparoscopic advantages such as mini lap incisions, more anatomic approaches and the use of spinal anesthesia [7,17,18]. Several authors [19–23] have compared the two approaches, but the results from the literature present several biases as they compare LRP with RRP being performed at different centres, with a different experience in prostate surgery between the surgeons, different period of ‘‘specific surgical experience’’ on prostate cancer, and often with the use of non-validated questionnaires to assess overall outcomes. Moreover, other studies lack a correct methodology, since they compare the first LRP performed with the last open procedures without taking in good account the completion of the learning curve for LRP. Finally, all these studies

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have neither a prospective nor a randomised design. All the above-mentioned issues stress the need for prospective and randomised trials to correctly evaluate peri- and post-operative results. A recent publication from Remzi et al. [24] compared morbidity between open prostatectomy, extraperitoneal and transperitoneal laparoscopic prostatectomy in a prospective fashion. Although interesting, the results seem to confirm that the key to a good prostatectomy lies more in the surgeons experience than in the technique and approach used. What makes our experience interesting is that the same group of surgeons, who are proficient in both techniques, routinely perform both approaches (open and laparoscopic) and therefore have completed the learning curve. Furthermore, the lead surgeon who performed both approaches had achieved the same anatomic and technical expertise in both laparoscopic and retropubic prostatectomy, reducing the previously described limits of other studies that compared surgeons at different points of the learning curve [20]. This has certainly allowed us to conduct this study in a prospective and randomised fashion. The two groups of patients were homogenous in terms of pre-operative parameters. In particular, the choice to limit maximum prostate size to 60 cc was related to the need to have standard operative conditions, without potential bias related to difficulties in the dissection of large prostates. When considering peri-operative outcomes, and in particular when evaluating surgical time, the real time of theatre occupation was considered, justifying our longer times, compared with those generally found in the literature [20,21]. Blood loss was significantly less in the laparoscopic group than in the open group. Of note, the number of nerve-sparing procedures, which usually are associated with a greater blood loss, was similar between the two groups. Furthermore, data from both groups were consistent with the literature [5,24]. However, in contrast to these findings, blood loss reported in recent series was higher in the laparoscopic group [19,20]. This finding can be related to the fact that in one series the surgeon was still in the laparoscopic learning curve [19], whilst in the other study the high number of patients T3 selected for surgery can explain partially the increased blood loss [20]. As far as pain is concerned and as already evidenced by Bhayani et al. [25], we did not find any significant differences in the post-operative period between the two groups, although the pain curve always was higher in the RRP group. Furthermore, although not statistically significant, the

laparoscopic group required less analgesia than the open surgery group throughout the hospital stay, as recently suggested in the literature [26]. Furthermore, Remzi et al. [24] confirm these data but suggest overall better pain control, both subjective and objective, after extraperitoneal laparoscopic prostatectomy, compared with the transperitoneal approach. These results also are confirmed by Rassweiler et al. [20], who described that 92% of patients who underwent LRP did not require pain control after POD2. Tewari et al. [27] also described a significant pain drop after robotic prostatectomy, compared with open surgery. Probably the good pain control achieved in both groups reported in our series could be due to the optimal and conservative analgesic regimen adopted. As recently reported by Salonia et al. [3], performing RRP under spinal anesthesia can certainly reduce post-operative pain; therefore, the anaesthesiologic regime adopted should be taken into consideration when comparing open surgery with laparoscopic surgery. As far as mobilization is concerned, all patients were encouraged and received assistance to get out of bed and become mobilized on POD 1; mobilization was more successful in the LRP group. Although our laparoscopic approach is transperitoneal, we did not find any difference in resuming oral intake, compared with the open extraperitoneal approach. This finding indeed suggests a reduced impact of transperitoneal-LRP on possible delays in bowel movements or general gastroenterologic symptoms. The significantly higher percentage of successful early catheter removal demonstrated in favour of the laparoscopic group suggests the superiority of the quality of laparoscopic uretravesical anastomosis. Interestingly, we experienced fewer cases of acute urinary retention after early catheter removal in the LRP and RRP groups, compared with the reports by Nadu et al. [28] and Lepor et al. [29]. This finding may be related to the timing we chose, suggesting that POD 5 could represent an adequate compromise between the risk of acute urinary retention and the concept of early catheter removal. Furthermore, the importance of a good anastomosis can be associated with a higher probability of successful early catheter removal and therefore with a reduction in anastomotic leakages; hence, the risk of anastomotic strictures is lower. According to our experience, the clear advantage of the laparoscopic anastomosis lies in the better vision under which knot tying is performed, although laparoscopic knot tying is technically more demanding than open knot tying and, indeed, requires adequate training in laparoscopic suturing. We speculate that this advantage

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can be the key to an overall better quality anastomosis, especially in deep bony pelvis where an open anastomosis can be more difficult to perform with care [14]. No major complication occurred in the RRP group, while one case of rectal injury occurred in the LRP group and was repaired successfully by the laparoscopic technique described previously by Guillonneau [30]. The evaluation of the rate of positive margins is mandatory for an adequate early oncologic assessment of the procedure. However, the definition of positive margin can lead to misinterpretations. According to our institution’s guidelines, a positive margin is at least one cancerous cell present at the inked surgical margin. The percentage of positive margins in both groups was comparable and in accordance with data from the literature. In particular, positive margins have been reported to range between 5% to 36% for pT2 and 8% to 53% for pT3 after open prostatectomy [31] and 1.8% to 21% (pT2) and 17% to 60% (pT3) in the most recent laparoscopic series [8]. However, these data, especially for laparoscopy, are bound to improve with the refinement of the technique [32], and these findings certainly seem to confirm the overall oncologic safety of laparoscopic prostatectomy. Furthermore, these results can be improved with the routine use of intra-operative frozen sections, as reported recently [33]. From our results, LRP showed some advantages over open surgery in the peri-operative period, such as a reduced blood loss and a greater chance of safe early catheter removal. Prolonged follow-up of both groups of patients is necessary to properly assess the potential differences between both procedures in terms of urinary continence and sexual potency recovery. Laparoscopic radical prostatectomy definitively is gaining popularity among the urologic community. However, the steep learning curve involved can discourage many centres from starting a dedicated programme, especially where accurate mentoring is unavailable and cost restrictions are difficult to overcome, while a proper general programme, as recently shown by the recent German experience, showed the efficacy of a training programme with a safe transfer of LRP from dedicated to naı¨ve centres [34]. Furthermore, until the real advantages of laparoscopic radical prostatectomy are demonstrated completely, it certainly will be difficult for those surgeons with a good ‘open’ experience to change their approach, starting from scratch a new procedure that needs at least 60/80 cases to overcome the learning curve, at least if a mentor is not employed [35].

5.

103

Conclusion

Although radical retropubic prostatectomy is the gold standard for the treatment of localized prostate cancer, laparoscopic prostatectomy is now an attractive alternative to open prostatectomy, offering significant advantages in terms of reduced blood loss and of a higher percentage of safe early catheter removal, with comparable early adverse advents. Furthermore, oncologic results seem comparable in terms of positive margins rates. However, long-term follow-up is needed to compare long-term functional results in terms of continence and potency. References [1] Walsh PC, Lepor H, Eggleston JC. Radical prostatectomy with preservation of sexual function: anatomical and pathological considerations. Prostate 1983;4:473–85. [2] Walsh PC. Radical prostatectomy for localized prostate cancer provides durable cancer control with excellent quality of life: a structured debate. J Urol 2000;163: 1802–7. [3] Salonia A, Crescenti A, Suardi N, et al. General versus spinal anesthesia in patients undergoing radical retropubic prostatectomy: results of a prospective, randomised study. Urology 2004;64:95–100. [4] Kundu SD, Roehl KA, Eggener SE, Antenor JAV, Han M, Catalona WJ. Potency, continence and complications in 3477 consecutive radical retropubic prostatectomies. J Urol 2004;172:2227–31. [5] Davis JW, Kuban DA, Lynch DF, Schellhammer PF. Quality of life after treatment for localized prostate cancer: differences based on treatment modality. J Urol 2001;166: 947–52. [6] Schuessler WW, Schulam PG, Clayman RV, Kavoussi LR. Laparoscopic radical prostatectomy: initial short-term experience. Urology 1997;50:854–7. [7] Guillonneau B, Cathelineau X, Barret E, Rozet F, Vallancien G. Laparoscopic radical prostatectomy: technical and early oncological assessment of 40 operations. Eur Urol 1999;36:14–20. [8] Omar AM, Townell N. Laparoscopic radical prostatectomy a review of the literature and comparison with open techniques. Prostate Cancer Prostatic Dis 2004;7:295–301. [9] Hoznek A, Menard Y, Salomon L, Abbou CC. Current opinion may 2005 Update on laparoscopic and robotic radical prostatectomy. Curr Opin Urol 2005;15:173–80. [10] Guillonneau B, Rozet F, Cathelineau X, et al. Perioperative complications of laparoscopic radical prostatectomy: the Montsouris 3-year experience. J Urol 2002;167:51–6. [11] Da Pozzo LF, Colombo R, Montorsi F, Guazzoni G, Rigatti P. An original balloon-expanding urethral suture guide for radical prostatectomy. Urology 1995;46:562–4. [12] Heidenreich A, Ohlmann Ch. The role of extended pelvic lymphadenectomy in men undergoing radical prostatectomy for prostate cancer. Eur Urol Update Series 2005;3:98– 106.

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