Jens Rassweiler^a,*, Marcel Hruza^a, Dogu Teber^a, Li-Ming Su^b
a Department of Urology, SLK Kliniken Heilbronn, University of Heidelberg, Germany
^b James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, MD, USA

Accepted December 14, 2005
Published online ahead of
print on January 18, 2006

Abstract

Objective: To evaluate the role of laparoscopic radical prostatectomy (LRP) and robotic assisted radical prostatectomy (RLRP) based on personal experience and a review of the literature.

Material and methods: Own experience at one European and one American LRP-center includes more than 2000 cases. We performed a MED- LINE search reviewing the literature on LRP and RLRP between 1992 and 2005 with special emphasis on historical aspects, technical considerations, comparison to open retropubic (RRP) and perineal radical prostatectomy (PRP), laparoscopic training, and the cost-efficiency of the techniques.

Results: Based on sophisticated training programs a continuous dissemination of the technique took place. In the United States, this process was accelerated by the use of the daVinci® -robot. There is a trend towards the extraperitoneal access. Mid-term outcomes of LRP achieved equivalence to open surgery with regards to complications, oncologic and functional results. Distinct advantages of LRP include less postoperative pain, lower rate of complications, shorter convalescence, and better cosmesis. In contrast to RLRP, LRP may reach cost-equivalence with open surgery (i.e. by reduction of OR-time, use of multi-usable instruments).

Conclusions: LRP reproduces the excellent results of open surgery providing the advantages of minimal access. Video-assisted teaching improves the transfer of anatomical knowledge and technical knowhow. In contrast the United States, the use of robots is likely to remain limited in Europe.

1. Historical aspects

Laparoscopic radical prostatectomy (LRP) has changed the role of video-endoscopic surgery in urology. In the nineties, laparoscopy represented a ‘‘nice technique looking for an indication’’ used only by dedicated centers for few indications of ablative surgery [1–3]. The successful application of laparoscopy to one of the most frequently performed urologic procedures (i.e. radical prostatectomy) by Guillonneau and Vallancien in 1998 initiated an increasing worldwide interest in minimal invasive surgery [4].

The successful establishment of LRP in Europe was supported by differences in the health care system as compared to the United States. In the USA, specialization is common with most pelvic cancer surgery performed by ‘‘urologic oncologists’’, whereas endoscopic and laparoscopic surgery is accomplished by ‘‘endourologists’’. In 1992, Schuessler, a non-academic urologist, attempted the first LRP assisted by two endourologists with laparoscopic experience in renal surgery [5]. These pioneers were able to successfully perform 9 LRPprocedures, but found no benefit over open prostatectomy [6].

Gaston [7], with laparoscopic experience in pelvic floor reconstruction started LRP in September 1997. This was additionally based on experience with open radical prostatectomy. One year later, in a similar setting, Guillonneau and Vallancien detailed their stepwise approach to LRP [4,8], and were followed shortly by several European centers [9–13]. In the USA, even experienced laparoscopists remained very skeptical about LRP. Gill, who at that time focused on renal laparoscopic surgery, was one of the few who established a program of laparoscopic pelvic surgery [14]. The real change of attitude towards LRP came about by Menon [15] who hired Vallancien and Guillonneau to train and establish LRP at his institution. Perhaps more importantly, was the introduction of the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA, USA) which allowed even a non-laparoscopic surgeon to accomplish minimally invasive prostatectomy.

LRP has slowly risen in popularity. In 2002, a survey of laparoscopic activities in Germany and Switzerland revealed that 15% of the departments performed LRP, but only 5% did more than 15 cases [16]. In 2004, already 19.2% of German departments offered LRP, whereas 26.9% preferred perineal, and 60.6% retropubic radical prostatectomy [17]. In 2006, a multi-center study of more than 5800 patients was published treated by 50 surgeons in Germany [18].

2. Material and methods

Experience at one European and one American LRP-center includes more than 2000 cases. In addition a MEDLINE-search was performed reviewing the literature (LRP and RLRP) between 1992 and 2005 including 17 comparative studies. Special emphasis was taken on history, technical evolution, comparison to open surgery (RRP, PRP), training, and the costefficiency of the techniques.

3. Results and discussion

3.1. Technical evolution

Four different approaches have been described: (i) transperitoneal descending prostatectomy with initial retrovesical dissection of the seminal vesicles [19], (ii) transperitoneal ascending prostatectomy [20], (iii) extraperitoneal descending technique [9,21] and (iv) extraperitoneal ascending technique [22].

3.1.1. Extraperitoneal versus transperitoneal approach
(Table 1)

Although the transferability of all four alternatives has been demonstrated [12,22–24], the extraperitoneal descending technique may have shorter learning curve [25] as reflected by the shorter operating times reported from centers just beginning LRP [18,26]. The two main advantages of this approach include: (i) the lower risk of bleeding due to early control of the lateral prostatic pedicles with the descending versus ascending technique, and (ii) elimination of the initial retrovesical dissection of the seminal vesicles in the extraperitoneal versus transperitoneal descending technique. Hoznek [27] showed that the elimination of the initial retrovesical dissection shortened the procedure by 50.6 minutes. The use of balloon dissection of the space of Retzius further reduces operative time. As all main operative steps of LRP (i.e. dissection of seminal vesicles, division of urethra and bladder neck) must be performed independent from the approach used, one would not expect the operating times to differ substantially in experienced hands.

However, certain patient characteristics and technical problems may make one approach more favorable than another. For examople, exposure of the Douglas in the transperitoneal descending technique may be met with difficulties in patients with a history of extensive pelvic surgery or a redundant sigmoid colon. Similarly, early division of the dorsal vein complex with the ascending technique in patients with a very large prostate may become more difficult.

Recently, comparable surgical results between extraperitoneal and transperitoneal LRP have been published [22,27–31]. However, there still exists a lack of consensus regarding the ideal approach. Some authors [27,29] emphasize the advantages of the extraperitoneal approach (i.e. reduction in bowel injury, ileus and peritonitis) concluding that this technique is superior to the transperitoneal access. Other authors [22,28] have found no significant differences between the two techniques calling it a ‘‘false debate’’. There are advantages and disadvantages for both approaches (Table 1a). The extraperitoneal approach may be preferable in certain circumstances, including (i) gross obesity, as the extraperitoneal approach may shorten the distance between trocar insertion site and operative field, (ii) previous abdominal surgery, as time-consuming adhesiolysis is avoided and the risk bowel injury miminized, and (iii) concurrent inguinal hernia as the extraperitoneal approach avoids the additional step of reperitonealization of the mesh prosthesis that is required with the transperitoneal approach.

Table 1 – Comparison of extraperitoneal versus transperitoneal LRP

In contrast, the transperitoneal approach offers minimal risk of lymphocele formation, particularly if extended pelvic lymph nodes dissection is indicated (Table 1b). These facts support the parallel use of both techniques at centers of LRPexpertise.

3.1.2. Retrograde versus antegrade nerve-sparing
(Table 2)

The evaluation of potency following laparoscopic preservation of NVB still remains in its infancy [23,32,33]. As in open surgery, there are two different techniques of nerve-sparing LRP, i.e.retrograde and antegrade approach. Whereas the retrograde technique is more popular in open surgery [34,35], most laparoscopic urologists favor the antegrade approach [23,32]. The main reason for this is the early control of prostatic pedicles and late division of the DVC as compared to the retrograde approach (Table 2) ensuring minimal bleeding and a clear working field, both of which are critical for identification, dissection, and preservation of the cavernous nerves.

LRP has stimulated a renewed interest in the periprostatic neuroanatomy. Because of the superior image and magnification, laparoscopists are able to better appreciate the fascial anatomy as described by Walsh [34,37,38]. Three fascial layers surrounding the anterior plane of the prostate can be distinguished: the endopelvic fascia, the lateral pelvic fascia and the prostatic capsule. The neurovascular bundles (NVBs) run within the two leaves of the lateral pelvic fascia, namely the levator and prostatic fascia and are bounded postero-medially by Denonvilliers’ fascia.

Guillonneau [19] described a completely antegrade dissection of the NVBs. One potential drawback of this approach is that the precise course of the NVBs is not easily visualized during antegrade dissection without having initially incised the levator fascia and developed a lateral NVB groove [33]. Gill recently proposed intraoperative transrectal ultrasound monitoring to identify the course of the NVB [39]. This technique uses Doppler signals to map the course of the cavernous vessels as a surrogate for the cavernous nerves. Much simpler, however, the technique of interfascial NVB dissection uses the prostatic fascia as a visible anatomic landmark for NVB-preservation [34–36].

Essential for the retrograde technique to NVB preservation is adequate experience in early control of DVC [40,41]. This technique offers the exact reproduction of the well-established open technique with earlier identification and release of NVB [34,35,42–44]. It should be noted, that neither technique represents a pure retrograde or antegrade approach (Table 2): In the retrograde technique, the bladder neck, seminal vesicles and prostatic pedicles are transected in an antegrade fashion, whereas the antegrade approach includes retrograde release of the apical course of the NVB [41]. Nevertheless, commonality exists with regards to accomplishing an interfascial dissection and early visualization of the NVB, use of task-specific instrumentation such as a fine right-angled and curved dissectors, and avoiding thermal energy during steps relevant to NVB preservation [45].

Table 2 – Advantages and disadvantages of retrograde versus antegrade neurovascular bundle preservation during laparoscopic radical prostatectomy

3.1.3. Robotic assisted laparoscopic radical prostatectomy

In 2000, Binder [46] performed the first telesurgical laparoscopic radical prostatectomy. In the same year, other European groups began performing RLRP [47–49]. In the USA, enthusiasm for the roboticassisted technique currently overshadows conventional LRP. Two series in the USA demonstarted the successful transfer from the open to laparoscopic technique by aid of the robotic device [50,51]. As a result, even surgeons inexperienced with laparoscopy wer able to perform minimally invasive prostatectomy without the time-intensive training necessary to gain the skills for LRP [52]. Public awareness of this robotic technology resulted in many patients in the USA seeking surgeons versed in RLRP. Consequently, even centres that are well recognized for their excellence .´n open radical prostatectomy, have begun to evaluate RLRP.

Of 209 systems installed worldwide in 2004, 92 (44%) were used to perform RLRP. Whereas 78 system existed in USA, only 14 were present in Europe [53], where the uncertainties in reimbursement for the device, the high costs for maintenance (10% of the price of ca. 1.2 Mio. Euro), and instruments (i.e. 1500 Euro/per case) significantly limited the distribution and acceptance. Whereas the initial OR-times were significantly longer compared to standard laparoscopic techniques (Table 3), recently Menon et al. [54,55] reported an OR-time of 140 minutes together with excellent continence and potency outcomes. Interestingly, no other group to date has been able to reproduce these figures [53,56–59]. Apart from the daVinci® -system, the voice-controlled robotic camera holder AESOP® is used frequently during standard LRP. This device enables the assistant to work with two hands, thus allowing the surgeon to routinely perform LRP with a single assistant [40].

Table 3 – Telesurgical laparoscopic radical prostatectomy – Review of the literature

3.2. Comparison with open series

Early laparoscopic series were initially compared to relevant contemporary series of open surgery [7,20,23,32,60]. For some oncological parameters (i.e. PSA-recurrence rate, progression free survival), this might be still necessary, however, most parameters have been currently addressed by various comparative studies, such as - single-center studies with comparison of historical groups treated sequentially (i.e. before and after introduction of LRP) by the same surgeons [7,61–63,67] - Single/double-center studies with comparison of two cohorts of patients treated parallel by different surgeons (i.e. laparoscopist versus open surgeon; [31,64–66,68–70])

To date there are no phase-III studies evaluating LRP versus RRP in the literature. This is mainly related to the fact that surgeons at most centers specialize in only one particular technique limiting the ability for recruitment of patients for a randomized study. As such, most comparative studies are biased (Tables 4 and 6). A major bias is related to the different levels of experience of the respective surgeons (Table 4). In order to eliminate such a bias, it is critical to define the learning curve for both procedures. Some authors reported that up tot 50 cases are necessary to master LRP [7,71,72]. The series of Scardino [73] reflect an on-going learning curve of RRP with a mean operating time decreasing during the period 1990 to 1994 from 217 minutes in the first to 170 minutes in the last year.

3.2.1. Operating time

One of the main critiques against LRP is the longer operative time [76]. Indeed, all ten comparative studies (Table 4) show longer OR-times for LRP (180– 330 min.) compared to RRP (105–197 min.). Frede [24], however, updated the learning curve of 1000 cases of LRP showing a decrease of OR-time from 332 minutes for the first to 196 minutes for the last 50 cases. The introduction of the extraperitoneal approach also resulted in a significant decline in ORtimes (Table 1), with some centers reproducing the operative times of open surgery [71,77,78].

3.2.2. Complications and morbidity

The low conversion rates in all major series are a testimony to the careful introduction of LRP [74]. With increasing experience, even challenging situations, such as cases following previous laparoscopic hernioplasty can be managed [79]. In a recent multicenter study [18], technical reasons (i.e. adhesions, difficulties with the urethro-vesical anastomosis, malfunctioning of instruments) or uncertain tumor anatomy (i.e. risk of positive margins) caused the conversion to open surgery rather than intraopera- tive complications, such as bleeding or visceral injury. Bhayani [80] noted only a 1.9% incidence of open conversions in a multi-institutional series citing prior pelvic surgery and morbid obesity as contributing factors.

Table 4 – Comparative studies of laparoscopic versus retropubic radical prostatectomy – Operative data

All except one of the comparative studies demonstrated a lower blood loss (LRP: 189–1100 ml vs. RRP: 550–1550 ml) and transfusion rate with laparoscopy (Table 4). The same applies to complication and reintervention rates. The lower incidence of complications includes bleeding, urine extravasation, wound healing, and thrombo-embolic events (Table 5a). A comparison of the identical number of patients (N = 1243) treated at two centers in Germany demonstrates similar patterns (Table 5b). A comprehensive description of incidence and types of complications following 567 consecutive LRPs over a 3-year period [60] revealed a total, major, and minor complication rate of 17%, 4%, and 14.6% respectively. Gonzalgo [81] applied a grading scheme designed to detail the frequency and severity of complications following LRP. A total of 34 (13.8%) morbidities were encountered during 246 LRP cases, the majority (94.1%) of which were self-limited (i.e. grade II–III). There were only 2 (5.9%) grade IVcomplications (i.e. potentially life threatening requiring intensive care unit management) and no grade V-complication (i.e. death). At centers of expertise, conversion and reintervention have become a rare event (less than 1%).

Table 5 – Comparison of the incidence of different complications after laparoscopic and open radical prostatectomy in the current literature [18,32]

3.2.3. Oncological results

The high incidence of positive margins in early LRPseries has been particularly criticized [13]. As with open surgery, the rate of positive surgical margins is related to many factors inclduing a surgeon’s experience [82]. None of the comparative studies have shown a disadvantage of LRP compared to RRP (Table 6). Based on a standardized LRP-training program, second and third generation surgeons did not have higher positive margin rates [24] Comparing recent results from larger open and laparoscopic series, the rate of positive margins were no different (Table 7), even if nerve-sparing surgery was performed [83].

Only mid-term results of LRP are available regarding biochemical recurrence. Guillonneau [84] reported an overall actuarial biochemical progression-free survival rate of 90.5% at 3 years. By pathologic stage, the rates were 92% for pT2a, 88% for pT2b, 77% for pT3a, and 44% for pT3b. Currently, no significant difference in oncologic results as compared to existing open series has been found in further series [61,85]. Additionally, there has been no report on port site metastases following LRP.

3.2.4. Continence

Only few comparative studies focus on functional results (Table 6). The two studies with inferior results for LRP regarding continence are both biased by the significantly different level of surgeon‘s expertise [66,69]. In fact, recently Janteschek presented a later set of 50 patients, with almost identical continence rates than Keller (PRP) and Schmeller (RPP) in a head-to-head comparison [70]. Evidently, the level of expertise significantly impacts on functional results, particularly concerning early recovery of continence. This is related to an improved apical dissection avoiding the use of monopolar coagulation close to the striated sphincter, minimizing the use of bipolar coagulation and anatomical dissection along the levator and prostatic fascia rather than to specific technical steps like the preservation of the puboprostatic ligaments or sparing of the bladder neck [62,78].

Table 6 – Comparative studies of laparoscopic versus retropubic radical prostatectomy – Functional and oncological data

With regards to the length of catheterization, independent of the suturing technique (i.e. interrupted vs. continuous suture) there seems to be a ‘‘biological limit’’ for complete healing of the vesicourethral anastomosis [60]. With the use of the single-knot-technique described by van Velthoven [86] a watertight anastomosis can be achieved in 90% of patients, however, urinary retention may occur up to 50%, if the catheter is removed early (i.e. day 3–5).

Table 7 – Positive margins following retrograde nervesparing radical prostatectomy - comparison of LRP and RRP [83]

3.2.5. Potency

Unlike the long-term potency data available from centers of excellence with RRP, only preliminary data are available for LRP [23,32]. Data concerning nerve-sparing PRP is also limited. Harris performed 60 nerve-sparing procedures among 508 patients (11.8%): 12 bilateral nerve-sparing procedures yielded successful intercourse in 3 cases [87]. At the moment, are no comparative studies that show inferior results with LRP (Table 6). In fact, our recently evaluated Heilbronn-LRP-series (N = 219) demonstrate comparable potency results of nervesparing RRP [35,88,89] using a similar retrograde technique (Table 8), and do not differ from large multicenter studies [90]. However, all of these comparisons are limited by differencies in population size, patient characteristics as well as multiple factors that are known to affect potency (e.g. medical comorbidities, available sexual partner).

Table 8 – Capability of sexual intercourse after antegrade nerve-sparing LRP (including the use of phosphodiesterase inhibitors in preoperatively potent patients) in comparison to nerve-sparing RRP [35,89]

3.2.6. Quality of Life

Although quality of life (QoL) has been well studied after open surgery, there are only a few comparative studies between LRP and RRP [91–94]. So ¨derdahl [92] found a similar 12 months-return to baseline of urinary (LRP 70.7% vs. RRP 71.0%) and sexual function (LRP 42.9% vs. RRP 39.0%). There was no significant difference between non-, unilateral and bilateral NVB-preservation. Yang [95] revealed a return to baseline sexual function in only 15.4% at 12 months following PRP, whereas return of urinary function was 73.4%. Link [93] found that patients reported an average return to 67% and 64% of baseline urinary and sexual function after LRP respectively.

Optimal outcome of LRP has not yet been achieved. QoL improved in 7.8% and remained stable in 37.4% of the first 500 patients who underwent LRP in Heilbronn [91]. Salomon [96] proposed a score to analyze the global results of radical prostatectomy according to the absence of biochemical progression (0–4), incontinence (0–2), and impotence (0–1). One year after radical prostatectomy, 20.0% had a score of 7, and 35.1% a score of 6, based on 85% with PSA below 0.2 ng/ml, 65.8% continence, and 32.7% erections. We applied the Salomon-Score on 217 patients followed by questionnaires after LRP and found similar results (score 7 = 22.1%, score 6 = 47.9%). However, this scoring system should be extended to include postoperative complications (0– 2). Furthermore, it should include a realistic baseline for each patient depending on individual tumor stage, age and preoperative erectile function [94].

3.2.7. Cost-effectiveness

Among the three cost-calculations in the literature [7,97,98], the initial calculations of Guillonneau [7] might not be considered as relevant. Both recently published studies from the US have to be carefully transferred to Europe. The model of Link [97] predicted a cost premium of 17.5% for RRP, mainly due to the longer OR-time (243 vs 160 minutes) and the use of surgical consumables, requiring a reduction of OR-time to 174 minutes for LRP to achieve cost equivalence. According to recent results, this goal is feasible, particularly, if reusable instruments are used. Lotan and colleagues [98] included RLRP in their analysis and found a cost advantage of RRP amounting $487 and $1,726 over LRP and RLRP respectively. An even shorter OR-time (140 vs. 160 minutes) and length of stay (1.2 vs. 2.5 days) did not compensate for the added expense of RLRP. There might be additional advantages for the minimally invasive techniques: A recent study of the University of Ulm [99] revealed an off-work time of 104 days following RRP in patients less than 56 years: 74.2% regained full fitness, 5.5% retired on grounds of age, 12.9% retired because of the disease, and 7.4% became unemployed. Within the first three years, the patient paid 466 Euro, the employer 6570 Euro, the health insurance 6,357 Euro, the pension scheme 13,305 Euro, and the employment office 3913 Euro (overall: 40,611 Euro). LRP with a shorter convalescence and a decreased postoperative morbidity could significantly reduce these costs.

3.3. Laparoscopic training

The successful transfer of LRP has mainly occurred at dedicated training programs [18,24,100,101] employing several training modules including:

• hands-on courses (dry and wet lab)
• cadaver courses
• live-demonstrations
• clinical training
• tutoring and mentoring

The most important step involves clinical training in operating room with step-by step learning of the procedure starting as first or second assistant and finishing with the entire operation tutored by an experienced laparoscopist [24]. All first generation centers in Europe established such training programs for their own staff as well as for external trainees (i.e. sponsored by the European Scholarship Program). Similar to video-TUR, endoscopic technology proved to be very helpful for clinical training.

The transmission of the image on a monitor allows for the entire operating team to appreciate the unique anatomic nuances of each individual case. Therefore, already the second assistant is totally aware of all anatomical details and each step of the procedure, a feature quite different from open surgery where typically only the surgeon wears magnifying loupes.

On the other hand, currently there are insufficient numbers of training sites. A recent survey found that 44% of interested European urologists defined the access to training facilities as insufficient. [100]. Moreover, such lengthy hands-on training programs are not readily available for the majority of postgraduate urologists in the United States due to the significant time and financial investment. Equally concerning, formal laparoscopic curricula for such a difficult procedure do not exist in the majority of American residency programs.

3.4. Advantages and perspectives of LRP

After only seven years, mid-term outcomes of LRP appear promising with regards to complications, oncologic and functional results, and have achieved equivalence to open surgery. The operating times are still somewhat longer, but many centers have already reported comparable operative times to open surgery. However, there are distinct advantages of LRP related to the less invasive approach:

• less postoperative pain
• lower rate of complications
• shorter convalescence
• better cosmesis

This is not primarily associated to the better operative technique, but to the reduced access trauma of laparoscopy. Despite the findings of Fornara [68] who did not detect any difference in acute phase serologic parameters (i.e. CRP, Interleukin 6) between LRP and RRP patients, the reduction of postoperative pain, complication rate, hospital stay, and convalescence still remain findings that are clinically appreciable with LRP.

Further potentials of LRP are related to videoendoscopy, providing optimal visualization of the periprostatic anatomy. This may lead to better preservation of the structures around the urinary sphincter (i.e.accessory pudendal artery), improved apical dissection and preservation of the neurovascular bundle [102,103]. Moreover, video-assisted teaching will improve the transfer of anatomical knowledge and technical knowhow. However, all of this must be confirmed by longer-term followup and adequately designed clinical studies.

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European Urology - 2006 04 (Vol. 49, Issue 4) p.612-624 Full Text

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