Laparoscopic & Robotic European Urology - Complications, Urinary Continence, and Oncologic Outcome of 1000 Laparoscopic Transperitoneal Radical Prostatectomies—Experience at the Charité Hospital Berlin, Campus Mitte | European Urology - Complications, Urinary Continence, and Oncologic Outcome of 1000 Laparoscopic Transperitoneal Radical Prostatectomies—Experience at the Charité Hospital Berlin, Campus Mitte |
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Volume 50, Issue 6, Pages 1278-1284 (December 2006) 1. Introduction: Radical prostatectomy is the standard therapy for localized prostate cancer. In the last 6 yr laparoscopic radical prostatectomy (LRP) has been performed with increasing frequency in both the United States and the European Union. Experienced surgeons in this field described various advantages of the laparoscopic procedure versus the open approach, such as optical magnification, less blood loss, less postoperative pain, and more rapid resumption of normal activities [1], [2], [3]. First performed by Schuessler et al. [4] in 1992, LRP was thought not to be feasible because of excessive operating times. However, in the European centres the feasibility could be demonstrated and the technique was standardised [5], [6], [7], [8]. Already in 2001, more than 1200 LRPs have been reported, mainly by European centres. Since 1999 LRP is the modality of choice for localized prostate cancer at the Charité University Hospital in Berlin, Campus Mitte, with an institutional experience of more than 1300 cases as of September 2005. The goal of this study was to evaluate the first 1000 patients treated by LRP and to compare the results with the current literature in this field. We focused on intraoperative early and late complications, positive surgical margins, urinary continence, and prostate-specific antigen (PSA)-free survival. 2. Methods Between May 1999 and October 2004, 1000 consecutive patients underwent laparoscopic transperitoneal radical prostatectomy (LRP) for localized prostate cancer performed by eight urologists at one institution (Department of Urology, University Hospital Charité, Campus Mitte, Berlin, Germany). The mean age of the patients was 62±6 yr (range: 37–75). The body mass index (BMI) ranged between 18.9 and 42.1 (average: 26.4). Of the 1000 patients, 404 (40.4%) had undergone abdominal operations before LRP. The most frequent operations before LRP were appendectomy (40%), herniotomy (28%), cholecystectomy (11%), transurethral resection of the prostate (8%), varicocelectomy (4%), colorectal surgery (2.5%), and transurethral resection of the bladder (1.7%). Mean preoperative PSA was 8.78ng/ml±5.2. All patients received low-molecular-weight heparin. Lymphadenectomy was performed in 552 men. The indication for lymphadenectomy was a >5% probability of lymph node metastasis according to the Kattan-Nomogramm. All 552 men had tumor-free lymph nodes. LRP was performed only when frozen sections of lymph node tissue were tumor free. Patients with lymph node–positive disease were not part of this evaluation. Clinical and pathologic staging was assigned by using the 2003 TNM classification. Each radical prostatectomy specimen was placed and fixed in 10% formalin, and the outer surface was inked completely to delineate the surgical margins. The prostate specimens were then sectioned transversely at 4- to 5-mm intervals. A positive surgical margin was defined as tumor cells reaching the inked surface. Data of all patients (n=1000) were retrospectively reviewed and recorded on the basis of complete clinical and pathologic documents at first. In a second step all patients received an informational letter and, 1–2 wk later, a personal nonvalidated questionnaire. This self-made questionnaire was completed by one physician via phone calls. The procedure was completed in July 2005. Questionnaires were completed for the 952 patients who could be reached. PSA-free survival was defined as the time between LRP and first PSA increase (>0.1ng/ml). All men who had received adjuvant treatment (hormone therapy or radiation) before an increasing postoperative PSA were noted and excluded from evaluation of PSA-free survival. Only 22 patients received neoadjuvant treatment >2 mo prior to surgery. Data were analysed with the use of the statistical software SPSS 12.0 (SPSS Inc, Chicago, IL, USA). The Mann-Whitney U test was calculated. The PSA-free rate was obtained by using a Kaplan-Meier analysis, and differences between progression-free rates were assessed by the log-rank test, Breslow test, and Tarone-Ware test. Cox hazard regression analysis was used to determine factors influencing PSA-free survival. Significance was defined as p<0.05. 3. Results All 1000 LRPs were completed laparoscopically, requiring no open conversion. Lymphadenectomy was performed in 552 patients and nerve-sparing LRP (243 unilateral and 122 bilateral) in 365 patients. The mean operating time of all procedures was 266min±93 (range: 102–810) and was influenced by individual experience of the urologist and by training situations (sharing of LRP by a senior surgeon and trainee). For experienced urologists (>100 LRP), mean operative time was 170min. Postoperative stage was pT2 pN0/pNX in 702 patients, pT3 pN0/pNx in 294, and pT4 pN0/pNX in 4. Positive margins occurred in 9% of pT2a, 19% of pT2b, 13% of pT2c, 53% of pT3a, and 60% of pT3b tumors (2003 TNM classification). Data are given in Table 1. After an informational letter was sent out, a questionnaire was successfully completed for 952 patients, 14 of whom had received adjuvant treatment before postoperative PSA started to increase. Therefore, only 938 patients were included in the calculation of the PSA-free survival rate. The PSA-free survival obtained using Kaplan-Meier analysis is shown in Fig. 1. According to the pathologic stage, the overall PSA-free rate was 94.8% (110 of 116) for pT2a, 94.5% (290 of 307) for pT2b, 97.1% (232 of 239) for pT2c, 80.3% (175 of 218) for pT3a, and 72.4% (42 of 58) for pT3b until July 2005. At this time the median follow-up was 28.8 mo (range: 7.2–69.7). The mean time to PSA progression was 64 mo for pT2a/pT2b, 53 mo for pT3a, and 50 mo for pT3b. For pT2c a shorter mean time to PSA progression (26 mo) was noted. This phenomenon can be explained by recruitment of only eight patients (pT2c) in this particular subgroup in the first 36 mo (May 1999–May 2002).
Fig. 1. Kaplan-Meier analysis of PSA-free survival according to pathologic stage (n=938). Cum.: cumulative. The multivariate Cox hazard regression analysis was calculated to identify influencing factors on PSA-free survival. Preoperative PSA, pathologic stage, positive or negative surgical margin, Gleason sum, and nerve-sparing LRP were tested. Three of five predictors were identified as significant variables. Gleason sum, surgical margin, and pathologic stage had significant impact on PSA-free survival (Table 2).
All complications were recorded on the basis of information from hospital records (n=1000) and from completed questionnaires (n=952). Intra- and postoperative complications occurred in 118 of 1000 (11.8%) patients and are listed in Table 3. These 118 patients had 128 complications. This complication rate was not significantly influenced by BMI, patient age, or operations before LRP. All intraoperatively identified rectum and bowl injuries (under laparoscopic conditions) were immediately sutured laparoscopically. One of the 42 patients concerned developed a rectal fistula later. In 25 patients a delayed bowel function was observed. All patients responded to conservative management. Two patients required surgical intervention for ileus. Three patients suffered from acute renal failure. Conservative management resulted in complete recovery of kidney function (n=2). The third patient received ureteral stents (Table 3). Neurologic lesions describe postoperative or late-sensitive or motoric malfunctions of different intensities.
In total, 15 patients treated with LRP died before July 2005. One patient died of sepsis (colon injury, dialysis, reoperations) 4 wk after LRP. Two patients had apoplexy or an embolic event, and died 3 and 4 wk after LRP. Therefore, the operative mortality rate was 0.3%. Three men died of metastasised prostate cancer (3.2, 3.5, and 3.7 yr, respectively, after LRP). Suicide and traffic accident were the reasons for the death of two of the patients. Seven patients died of another cancer entity. In 970 patients the urethrovesical anastomosis was tested by cytography (X-ray contrast medium via bladder catheter) on day 5 or 6 after LRP. A leakage was identified in 217 (22.3%) patients; in 753 (77.6%) the anastomosis was complete. The median catheter time was 6.2 d (range: 5–32). The median hospital stay was 7 d. Urinary continence was assessed in 952 men. To avoid misinterpretation of assessment and comparability, only the number of pads per 24h is documented. Of the 952 patients treated with LRP, 76% used a maximum of one pad per 24h; 24% of patients needed two or more pads per 24h. 4. Discussion Radical prostatectomy is considered the most effective treatment option for localized prostate cancer. Laparoscopic radical prostatectomy was introduced to combine the advantage of open prostatectomy with the benefits of minimally invasive surgery. With better visualization of the anatomy and a relatively bloodless field, laparoscopic radical prostatectomy has the potential to give a good functional outcome with equal oncologic effectiveness [1], [2], [3], [9]. The focus of this paper is on assessment of complications, oncologic outcome, and urinary continence. Previous reviews were dealing with detailed comparisons between the open and the laparoscopic approach [2], [9], [10], [11], [12], [13], [14]. Therefore, only the main aspects of these reports will be discussed. The impact of a sexual dysfunction will be part of a separate report. Moreover, the influence of lymphadenectomy, unilateral and bilateral nerve-sparing LRP, and urologist's (surgeon) experience on operating time, complications, and functional and oncologic outcome will also be part of a separate paper. The mean operating time was 266min performed by eight urologists for all laparoscopic procedures. The duration can be considerably reduced depending on the urologist's experience [15]. In our study, those urologists with an extensive laparoscopic experience (>100 LRP) had an average operating time of 170min. Importantly, learning curves can be accelerated through effective training programmes and mentoring. Cure of the patient from prostate cancer is the primary goal of radical prostatectomy [16], [17]. The definitive assessment of cure of this cancer entity needs a longer follow-up (7–15 yr); our data and other currently available data can provide only medium-term results. PSA-free survival is an established parameter regarding oncologic outcome [18], [19], [20]. Guillonneau et al. [5] reported the oncologic outcome of 1000 patients after LRP [5]. They reported an overall actuarial biochemical PSA-free survival between 88% and 92% for pT2, and between 44% and 77% for pT3 at 3 yr (median follow-up: 12 mo). These cancer control rates by pathologic stage are within the confidence ranges reported by other centres. Nevertheless, present data of 1000 patients with a median follow-up of 28.8 mo (range: 7.2–69.7) show encouraging data for LRP. It has been postulated that LRP resulted in a higher rate of positive margins. For an objective evaluation of the positive margin rate, three aspects have to be considered. The first is the technique of histopathologic examination, because pathologic evaluation of the prostate can influence the incidence of positive margins. The second aspect is the stratification of positive margin rates according to the pathologic stage (pT2 or pT3). The third aspect is the case selection (with or without adjuvant therapy). Comparison of the rate of positive margins after open or laparoscopic procedure did not show a significant difference [1], [2], [9], [10], [21]. We believe that, with an increasing number of published laparoscopic series focusing on PSA-free survival, the “problematic” discussion regarding positive surgical margins will become more objective. Most importantly, recent studies could not detect any specific oncologic risk or side-effects related to the laparoscopic technique. Our clinic is not systematically performing neoadjuvant treatment. We had 22 patients who had neoadjuvant treatment from other urologists. This number is too small to draw any conclusions on the effect of a neoadjuvant strategy in this cohort. One main object of the present study was to report and clearly describe all complications [13], [22], [23], [24], [25]. The most frequent intraoperative complication was rectal injury. All rectal and bowel injuries were repaired laparoscopically. It is of interest, that only one of the patients developed a fistula. A total of 14 of 952 (1.5%) patients developed fistula or abscess as late complications. Reliable information about severe late complications is rarely reported in the literature. Two (0.2%) patients required reoperation because of ileus. Frequent late complications were neurologic lesions of various intensities. It is of note that this specific symptom was rarely documented during the hospital stay immediately after LRP. The proportion of patients transfused during and after LRP is relatively low (2.2%), which reflects the minimal amount of blood loss during the laparoscopic procedure [2], [5], [9]. Anastomotic stricture was rarely observed (0.2%). This fact could be attributed to the watertight urethrovesical anastomosis. The bladder catheter limits activity and is one of the most troublesome postoperative aspects for the patients. In the present study, cystography was used routinely before catheter removal. Anastomotic leakage was detected by cystography in 217 of 970 (22.3%) men on day 5 or 6 after LRP. Creating the anastomosis under favourable visual control during the laparoscopic procedure allows the catheter to be withdrawn early [5], [10], [23]. It should be taken into account that 1000 LRPs were performed by eight urologists, including eight training phases [15]. Nevertheless, the complication rate proves that LRP can be learned in a high-volume centre without disadvantage for the patients. The quality of life after surgery is strongly affected by urinary incontinence. Published reports on the rate of urinary incontinence after radical prostatectomy vary widely [26], [27], [28], [29], [30]. There are several reasons for this unsatisfactory situation. It had been shown that incontinence depended on the urologist's experience, patient's age, operative technique (e.g., nerve sparing), and methods of analysis [2], [9], [28], [29], [30]. The definition of continence reported in the literature is not uniform (i.e., no pads, safety pads, socially dry). Frequently, full continence is defined as no need for any pads during normal daily activity. However, the different modalities of continence evaluation vary widely (self-assess of the urologist, interview by urologist or an independent physician, questionnaire). In addition, the follow-up time plays a crucial role. Taken together, no consensus has been reached. The different definitions and evaluation methods result in a limited comparability of the radical prostatectomy techniques (laparoscopic, perineal, retropubic). To avoid such misinterpretations, we recorded only the total number of pads per 24h in the present study. We noted in 76% of patients a maximum of one pad per 24h with a median follow-up of 28.8 mo. In summary, there are no significant differences between our result and published data of the open approach (61–96%). Our experience reflects the result of an academic center with many surgeons in training. 5. Conclusions Our results of 1000 LRPs found no disadvantages of the laparoscopic approach regarding complications, urinary continence, and oncologic outcome compared with open surgery series in the literature. To address the oncologic effectiveness of the laparoscopic approach, long-term follow-up is necessary. Editorial Comment
As one of the first institutions world-wide, the Charité started with laparoscopic radical prostatectomy (LRP) in 1999, after French working groups demonstrated that LRP is feasible with acceptable operating time and oncological results [1]. Thus, the series presented by Lein et al. includes all the pioneered work that was necessary in order to make laparoscopy a challenge for radical prostatectomy. Meanwhile, LRP has become more and more accepted in the community of urological surgeons. However, the most important factor that drives LRP into a widespread accepted surgical alternative is the patient-driven desire for a minimally-invasive treatment to cure them from their cancer. The historical series of 1000 procedures has also to be seen in this context. Lein and colleagues are reporting on one of the earliest and largest single institution series on LRP in localized prostate cancer. 1000 procedures were performed by 8 urologists. The manuscript is focusing on perioperative results, including complications, functional and oncological outcome over a period of over 5 years. This article is of great importance because it presents one of the largest series of LRP with considerable follow-up obtained not only by one surgeon, but several different surgeons with their individual entire learning curve. As a result of this retrospective analysis oncological results after LRP seem to be comparable to oncological results after open RRP. Earlier reports of a higher rate of positive margins after LRP could not be reconfirmed in later series with more experienced surgeons [2]. The risk of perioperative bleeding with LRP is 2.2%. Thus, it is lower as usually published for open series. However, functional results including voiding parameters and erectile function are unfortunately not mentioned in this paper. As in the majority of papers dealing with postoperative incontinence after radical prostatectomy a comparable and standardized evaluation using validated questionnaires was not used. This makes comparison difficult because the term “pad usage” for instance is extremely variable and does not reliably inform about postoperative continence status. Besides, data on postoperative erectile function are not presented. However, these issues are of growing importance, because more and more patients with prostate cancer are not seeking radical oncologic surgery only, but also want to have an acceptable quality of life after surgery. Driven by the desire of a preferably minimally-invasive treatment without the risk of postoperative urinary incontinence, the majority of prostate cancer patients in the US are now choosing radiation therapy or interstitial brachytherapy instead of radical surgery; this, although oncological and functional results are not better than prostatectomy. In this context LRP might be a minimally-invasive surgical treatment alternative for open RRP and radiation therapy with good functional and oncolocgical results and a low rate of complications. References31. [1]. Laparoscopic radical prostatectomy. Preliminary evaluation after 28 interventions. Presse Med. 1998;27:1570–1574. 32. [2]. Laparoscopic radical prostatectomy. Experiences with 145 interventions. Urologe A. 2001;40:199–206. Editorial CommentXavier CathelineauThe authors report their large experience in laparoscopic radical prostatectomy with a focus on complications, positive surgical margins and functional results. Several points must be underlined: It has already been demonstrated that experience allows reduction of complication rate. Training of urologists in laparoscopic surgery is essential and the authors confirms that the learning curve can be accelerated through effective training programmes and mentoring. Curing the patient from prostate cancer is the primary goal of radical prostatectomy. Decreasing the rate of positive surgical margin remains necessary to reach this objective, whatever the approach, open or laparoscopic. Some important information should be reported in this way: which technique of nerve sparing was used (intrafascial or interfascial: some surgeons clearly report an intrafascial technique, others prefer to keep a security margin)? Prostate volume and number of blocks must be systematically defined on the pathological report. Concerning functional results, it is like the Babel tower: urologists must use the same language! If we want, really want, to obtain the truth in order to improve our technique and be able to compare it to other treatments, we have to use an international validated self-questionnaire, compiled by the patient, at home. We must also specify which patients were evaluated (preoperative status) and when (6 months, 1, 2, 3 years postoperatively). Adapted training programmes and strict evaluation is the best way to improve our results and give objective information to the patient.
References Michael Leina, Inna Stibanea, Ramin Mansoura, Claudia Hegea, Jan Roigasa, Andreas Willea, Klaus Junga, Glen Kristiansenb, Dietmar Schnorra, Stefan A. Loeninga, Serdar Degera
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