Laparoscopic Radical Prostatectomy - the Experience of the German Laparoscopic Working Group

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1 european urology 49 (2006) available at journal homepage: Laparoscopy Laparoscopic Radical Prostatectomy - the Experience of the German Laparoscopic Working Group Jens Rassweiler a, *, Jens Stolzenburg b, Tullio Sulser c, Serdar Deger d,jürgen Zumbé e, Georg Hofmockel f, Hubert John g,günther Janetschek h, Jean-Luc Fehr i, Martin Hatzinger j, Michael Probst k, Karl-Heinz Rothenberger l, Vassilis Poulakis m, Michael Truss n, Gralf Popken o, Jens Westphal p, Uwe Alles q, Paolo Fornara r a Department of Urology, SLK Kliniken Heilbronn, University of Heidelberg, Am Gesundbrunnen 20, D Heilbronn, Germany b Department of Urology, University of Leipzig, Germany c Department of Urology, University of Basel, Germany d Department of Urology, University of Berlin, Campus Charité Mitte, Germany e Department of Urology, Klinikum Leverkusen, Germany f Department of Urology, Klinikum Worms, Germany g Department of Urology, University of Zürich, Germany h Department of Urology, Elisabethenkrankenhaus Linz, Germany i Department of Urology, Kantonsspital Schaffhausen, Germany j Department of Urology, University of Mannheim, Germany k Department of Urology, University of Frankfurt, Germany l Department of Urology, Klinikum Landshut, Germany m Department of Urology, Nord-West-Krankenhaus Frankfurt, Germany n Department of Urology, University of Hannover, Germany o Department of Urology, Helios-Kliniken Berlin, Germany p Department of Urology, St. Josephshospital Krefeld-Uerdingen, Germany q Department of Urology, Klinikum Kaiserslautern, Germany r Department of Urology, University of Halle, and the Laparoscopic Working Group of DGU, Germany Article info Article history: Accepted October 4, 2005 Published online ahead of print on November 2, 2005 Keywords: Prostate cancer Laparoscopy Prostatectomy Abstract Purpose: To present the current status of laparoscopic radical prostatectomy (LRP) in Germany, Austria and Switzerland with respect to transferability, learning curve, and outcome. Material and methods: The data of 5824 patients who underwent LRP in 18 centers by 50 urologists from March 1999 to August 2004 were analyzed retrospectively. Three centers performed more than 500, and six more than 250 cases. A transperitoneal descending technique with was used in 2701, a transperitoneal ascending in 1234, an extraperitoneal descending in 1814, and an extraperitoneal ascending modification in 75 cases. * Corresponding author. Tel ; Fax: address: jens.rassweiler@slk-kliniken.de (J. Rassweiler) /$ see front matter # 2005 Elsevier B.V. All rights reserved. doi: /j.eururo

2 114 european urology 49 (2006) Specimen showed pt2 in 3535, pt3a in 1555, pt3b in 623, and pt4 in 111 cases. Results: Mean operating time averaged 211 ( ) minutes, with shorter duration of the extraperitoneal descending technique. Conversion to open surgery averaged 2.4 (0 14.1) %. Re-intervention rate amounted to 2.7 ( ) %. Complication rate averaged 8.9 ( ) % including bleeding ( %) and rectal lesion ( %). The rate of positive margins was 10.6 (3.2 18) % for pt2- and 32.7 ( ) % for pt3a-tumors Continence after 12 months was 84.9 (72 94) %. Data about potency (7 centers) revealed 52.5 (35 67) % full erections following bilateral nerve preservation. 5 year- PSA recurrence rate (3 centers) was 8.6 (4 15.3) % for pt2-tumors and 17.5 ( ) % for pt3a-stages. Conclusions: The results confirm the efficacy of the training program with safe transfer of LRP (i.e. low complication rate), however including all known problems of a retrospective study. # 2005 Elsevier B.V. All rights reserved. 1. Introduction In 1999, Guillonneau and Vallancien presented early results of LRP [1,2]. Interested urologists mainly in Europe replicated the procedure using either the same technique or modifications [3 8]. Although there was no rapid distribution, a slow but continuous diffusion took place during the last three years [9 13]. In 2002, the German laparoscopic working group presented a survey of activities in Germany and Switzerland [14]: 15% performed LRP, but only 5% did more than 15 cases. In 2004 another survey [15] revealed, that 38 (19.2%) of 195 German urological departments offered LRP to their patients, whereas 26.9% preferred perineal, and 60.6% retropubic radical prostatectomy. The laparoscopic working group of the German Urological Association (DGU) retrospectively collected the data of 18 centers with established LRP-programs in Germany, Austria and Switzerland focusing on transferability, learning curve, and outcome. 2. Material and methods 2.1. Centers (Table 1) Eighteen urological departments participated on this retrospective multi-center study. From March 1999 to August 2004, 5824 patients with a mean age of 64 (41 81) years underwent LRP performed by 50 surgeons. Four centers started in 1999, three in 2000, four in 2001 and 2002 respectively, and three in Three centers performed more than 500, six more than 250 cases. The senior surgeons of the first seven centers (1st generation) served as tutors for the following centers respectively the surgeons at their own department (2nd and 3rd generation) Surgical technique A transperitoneal descending technique (Montsouris) was used in 2701, a transperitoneal ascending (Heilbronn) in 1234, an extraperitoneal descending (Bruxelles, Leipzig) in 1814, and an extraperitoneal ascending (modified Heilbronn) in 75 cases The da Vinci-robot (Intuitive surgical, Sunnyvale, USA) was routinely in use at 2 centers. Pelvic lymph node dissection (PLND) was carried out in every case (7 centers) or according to the EAU-guide-lines on prostate cancer (Gleason less than 7, PSA less than 10 ng/ml) Patient selection All tumors were clinically T1c or T2. Pathological examination revealed pt2 in 60.7 ( ) % (n = 3535), pt3a in 26.7 ( ) % (n = 1555), pt3b in 10.7 ( ) % (n = 623), and pt4 in 1.9 (0 2.9) % (n = 111). Three centers pre-selected their patients for LRP (small glands, T1c) Evaluation of outcome According to the study design, there was no reference pathologist, however positive margins were evaluated strictly according the Stanford protocol. Data of continence and potency were only taken from those centers providing adequate follow-up as well as the use of validated questionnaires [21] Statistical analysis We used a questionnaire focusing on operative data (i.e. number of surgeons, type of technique, instruments for hemostasis, operating time, cases with uni-/bilateral preservation of the neurovascular bundle), complication (i.e. transfusion rate, conversion and re-intervention rates, type of complications, type of reintervention) as well as functional (i.e. continence and potency at 12 months) and oncological results (pathological stages, positive margins, PSA-recurrence). The data were recorded in a database (Excel, Microsoft).

3 european urology 49 (2006) Table 1 Participating centers Center N Surgeons Main technique Since Heilbronn Transperitoneal ascending 1999 Berlin-Charite Transperitoneal descending 1999 Zürich a Transperitoneal descending 1999 Schaffhausen Transperitoneal descending 1999 Basel Transperitoneal descending 2000 Frankfurt a Transperitoneal descending 2000 Leverkusen Transperitoneal descending 2000 Leipzig Extraperitoneal descending 2001 Worms Transperitoneal descending 2001 Berlin-Buch Extraperitoneal descending 2001 Linz Transperitoneal descending 2001 Landshut Extraperitoneal descending 2002 Mannheim Transperitoneal ascending 2002 Hannover 78 2 Extraperitoneal descending 2002 Krefeld Extraperitoneal descending 2002 Frankfurt-NW Extraperitoneal descending 2003 Kaiserslautern 70 1 Extraperitoneal descending 2003 Halle 65 2 Extraperitoneal descending 2003 Total a da Vinci-robot. The statistical analysis was performed using a commercial software package (SPSS, Microsoft). 3. Results 3.1. Operative data (Table 2) extra- vs. transperitoneal descending or ascending technique (176 vs. 211 vs. 232 min.), and a significantly longer duration of da Vinci (277.5 min.) LRP included PLND in 68%. 17 of 18 centers used bipolar coagulation, 12 an ultrasonic dissector, and only 3 lockable clips. Transfusion rate was 4.1 (0 to 15) %. Mean operating time averaged ( ) minutes, with a significantly shorter duration of Table 2 Operative results 3.2. Complications (Table 3) Conversion to open surgery amounted to 2.4 (0 14.1) %, predominantly due to technical reasons (adhesions, OR-time) and bleeding. Re-intervention rate Criteria Mean All centers min max OR-time (min.) Transperitoneal descending - Extraperitoneal descending - Transperitoneal ascending PLND (%) Techniques of hemostasis - Bipolar coagulation 17/18 n.a. n.a. - Ultrasonic dissector 12/18 n.a. n.a. - Titanium-clips 9/18 n.a. n.a. - Hemo-lock-clips 3/18 n.a. n.a. Conversion (%) Bleeding Ureteral injury Bowel injury Adhesions Tumor (size, margins) Techniuqe (anastomosis, OR-time) Transfusion (%) Table 3 Complications Criteria Mean All centers min max Re-intervention (%) Bleeding Rectal fistula Lymphocele Hydronephrosis Infection Anastomotic stricture Re-intervention (%) by - Open surgery Laparoscopy Endourology Complication (%) Bleeding rectal lesion extravasation ,0 - thrombo-embolism Last year conversion (%)

4 116 european urology 49 (2006) Fig. 1 Re-intervention rates (%) at 18 centers arranged by decreasing number of cases (open versus minimally invasive management). Fig. 2 Positive margin rates (%) at 18 centers arranged by decreasing number of cases (pt2 vs. pt3). amounted to 2.7 ( ) % requiring open surgery in 1.4%, laparoscopy in 0.2%, and endourology in 1.1% (Fig. 1). The complication rate averaged 8.9 ( ) % including urine extravasation (2.4%), bleeding (2.2%), and rectal lesion (1.7%). Table 4 Oncological and functional results Criteria Mean All centers min max 3.3. Oncological results (Table 4) Rate of positive margins averaged 10.6 (3.2 18) % for pt2- and 32.7 ( ) % for pt3a-tumors (Fig. 2). Long-term data from three centers (Heilbronn, Basel, Zürich) showed 5 years-psa recurrence rate of 8.6 (4 15.3) % for pt2- and 17.5 ( ) % for pt3a-stages Functional results (Table 4) Continence (no pad) was reported in 84.9 (72 94) % after 12 months (12 centers) (35 to 67) % of patients engaging in intercourse preoperatively, who underwent bilateral nerve preservations Pathological stages (%) - pt pt3a pt3b pt Positive margins (%) - pt pt3a pt3b PSA-recurrence (%) - pt pt3a Continence at 12 mos. (%) Potency at 12 mos. (%) - Unilateral nerve-sparing Bilateral nerve-sparing

5 european urology 49 (2006) reported the ability to engage in sexual intercourse including the use of phosphodiesterase type 5 inhibitors (7 centers). 4. Discussion Apart from an abstract at the AUA-meeting 2001 [16], only single-center reports have been published. We present the first multi-center study focusing on the reproducibility of LRP Technical aspects Four modifications were used: transperitoneal descending with posterior dissection of seminal vesicles, transperitoneal ascending, extraperitoneal descending, and extraperitoneal ascending. We found a trend towards extraperitoneal descending LRP popularized by Stolzenburg in our group using workshops, live-demonstrations, and tutorial activities. Although the transferability of all alternatives was demonstrated [11,16,17], extraperitoneal descending LRP seems to be easier to learn as reflected by shorter operating times of recently starting centers. The main reasons for this represent the lower risk of bleeding due to early control of lateral prostatic pedicles, and the elimination of posterior dissection of seminal vesicles. Hoznek [18] reported, that this resulted in a shortening of extraperitoneal versus transperitoneal LRP by 50.6 minutes. Almost all surgeons used bipolar coagulation, 50% Titanium clips, and only 16% lockable polyurethane clips. This is related to the popularized application of ultrasonic dissectors. However, with gaining experience some centers abandoned the use of this device due to cost reasons [4]. On the other hand, reusable ultrasonic devices (i.e. Sonosurg, Olympus) may represent a more cost-effective alternative Learning curve The learning curve has flattened significantly yielding a last year conversion rate of 0.9%. The low conversion rates testify the careful introduction of LRP. Predominantly, technical problems (adhesions, difficulties with anastomosis, malfunctioning of instruments) or unclear pathology (risk of positive margins) caused conversion to open surgery rather than intraoperative complications (bleeding, visceral injury). Re-interventions were indicated due to immediate or delayed complications including rectal fistula, hemorrhage, and hydronephosis. Formation of lymphoceles occurred exclusively following extraperitoneal LRP. The overall rate of 2.7% is remarkable low, particularly since only 1.4% required open surgery, whereas 1.1% could be managed percutaneously (by drainage, nephrostomy) or endoscopically (Fig. 1). The complication rate of 8.9% reflects the successful transfer of LRP. Recently, Augustin et al. [19] reported a complication rate of 19.8% in a consecutive series of 1243 contemporary radical retropubic prostatectomies. One may also consider catherization time and hospital stay as important factors to determine the learning curve. However, we feel that both parameters are influenced considerably by factors not being involved in the learning curve such as the suturing technique of the anastomosis, the regimen of cystogram/catheter removal, and patients compliance (i.e. to be discharged with an indwelling catheter) Laparoscopic training The transfer of LRP is based on dedicated training programs. Such programs include several modules [13,17]: hands-on courses, live-demonstrations, clinical training, and tutoring. All surgeons participated on hands-on training courses, and live/videodemonstrations of the surgical technique [13]. However, most important is clinical teaching with step-by-step learning of the procedure starting as second assistant and finishing with the entire operation tutored by an experienced laparoscopist [17]. Within the last years, all 1st generation centers established such training programs for their own staff as well as for external trainees. Hence, 2nd generation centers, either started accompanied by external tutoring or after finishing a complete training program at a 1st generation center. The video-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 [17]. 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 [20] Robotic laparoscopic radical prostatectomy Recently, predominantly in the United States, the use of the davinci-system became popular. Studies showed, that the davinci-system alleviates transfer of surgical expertise from open to laparoscopic technique [9,10]. In our study, however, only two centers regularly used the davinci-system. Due to

6 118 european urology 49 (2006) the much higher number of operations in the US, a comparison of results is limited Oncological aspects The surgical margin rates are comparable to open series [21]. The significant variation between the individual centers (Fig. 2) might be attributed to the fact, that there was no reference pathologist. However, particularly the rate of positive margins depends on the surgical expertise [11]. Long-term data cannot be presented in this study, but midterm data of three centers confirm the results of Montsouris [22] Functional aspects The continence rate of 85% after 12 months is in accordance with reports of open or laparoscopic radical prostatectomy [21]. The fact, that only 7 of 18 centers preserved the neurovascular bundle (NVB), reflects the early stage of distribution of LRP in the DGU. However, not all open centers, routinely preserve NVB. Apart from Huland s group [20], there are no valid publications concerning the outcome of nerve-sparing retropubic radical prostatectomy. Due to laparoscopy, the interest in preservation of NVB increased. Therefore, we anticipate significant improvement of our results in the near future. 5. Conclusion The results confirm the efficacy of the training program with safe transfer of LRP. Since the learning curve flattened in a reasonable time, we anticipate the transfer of existing open and laparoscopic expertise for further optimization of oncological and functional outcomes. However even if these results are based on more than 5500 cases, one must consider the limitations of a retrospective study, such as selection bias or validity regarding the incidence of complications. References [1] 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: [2] Guillonneau B, Vallancien G. Laparoscopic radical prostatectomy: the Montsouris Technique. J Urol 2000;163: [3] Jacob F, Salomon L, Hoznek A, Bellot J, Antiphon P, Chopin DK, et al. Laparoscopic radical prostatectomy: preliminary results. Eur Urol 2000;37: [4] Rassweiler J, Sentker L, Seemann O, Hatzinger M, Rumpelt J. Laparoscopic radical prostatectomy with the Heilbronn technique: an analysis of the first 180 cases. J Urol 2001; 160: [5] Türk I, Deger IS, Winkelmann B, Roigas J, Schoenberger B, Loening SA. Laparoscopic radical prostatectomy: technical aspects and experience with 125 cases. Eur Urol 2001;40: [6] Bollens R, Vanden Bossche M, Roumeguere Th, Damoun A, Ekane S, Hoffmann P, et al. Extraperitoneal laparoscopic radical prostatectomy: results after 50 cases. Eur Urol 2001;40:65 9. [7] Gill I, Zippe C. Laparoscopic radical prostatectomies: Technique. Urol Clin North Am 2001;28:423. [8] De la Rosette JJMCH, Abbou CC, Rassweiler J, Pilar Laguna M, Schulman CC. Laparoscopic radical prostatectomy: a European virus with global potential. Arch Esp Urol 2002;55: [9] Menon M, Shrisvastava A, Tewari A, Sarle R, Hemal A, Peabody JO, et al. Laparoscopic and robot assisted radical prostatectomy: Establishment of a structured program and preliminary analysis of outcomes. J Urol 2002; 168: [10] Ahlering TE, Skarecky D, Lee D, Clayman RV. Successful transfer of open surgical skills to a laparoscopic environment using a robotic interface: initial experience with laparoscopic radical prostatectomy. J Urol 2003;172: [11] El-Feel A, Davis JW, Deger S, Roigas J, Wille AH, Schnoor D, et al. Positive margins after laparoscopic radical prostatectomy: A prospective study of 100 cases performed by 4 different surgeons. Eur Urol 2003;43: [12] Stolzenburg JU, Do M, Rabenalt R, Pfeiffer H, Horn L, Truss MC, et al. Endoscopic extraperitoneal radical prostatectomy: initila experience after 70 procedures. J Urol 2003;169: [13] Laguna PM, Hatzinger M, Rassweiler J. Simulators and endourological training. Curr Opin Urol 2002;12: [14] Vögeli TA, Burchardt M, Fornara P, Rassweiler J, Sulser T, Laparoscopic Working Group of the German Urological Association. Current laparoscopic practice patterns in urology: results of a survey among urologiss in Germany and Switzerland. Eur Urol 2002;42: [15] Protzel C, Pechoel M, Richter M, Zimmermann U, Klebingat K. Radikale Prostatektomie und pelvine Lymphadenektomie aktuelle Therapiestrategien in Deutschland Ergebnisse einer deutschlandweiten Umfrage. Urologe A 2004;43:S59, (abstract P klin 6.5). [16] Sulser T, Guillonneau B, Vallancien G, Gaston R, Piechaud T, Türk I. Complications and initial experience with 1228 laparoscopic radical prostatectomies at 6 European centers. J Urol 2001;165(Suppl):150. [17] Frede T, Erdogru T, Zukosky D, Gulkesen H, Teber D, Rassweiler J. Comparison of training modalities for performing laparoscopic radical prostatectomy: experience with 1,000 patients. J Urol 2005;174:673 8.

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