european urology 49 (2006)

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1 european urology 49 (2006) available at journal homepage: Kidney Cancer Retroperitoneoscopic Versus Open Surgical Radical Nephrectomy for Large Renal Cell Carcinoma in Clinical Stage ct2 or ct3a: Quality of Life, Pain and Reconvalescence Wolfgang Dillenburg a, *, Vassilis Poulakis a, Konstantinos Skriapas a, Rachelle de Vries a, Nikolaos Ferakis a, Ulrich Witzsch a, Michael Melekos b, Edward Becht a a Department of Urology and Pediatric Urology, Northwest Hospital, Stiftung Hospital zum Heiligen Geist, Frankfurt am Main, Germany b Department of Urology, University Hospital of Larissa, Larisa, Greece Article info Article history: Accepted October 25, 2005 Published online ahead of print on December 9, 2005 Keywords: Laparoscopy Retroperitoneoscopy Extraperitoneal Nephrectomy Kidney cancer Renal cell carcinoma Large renal tumor Abstract Objectives: To determine whether retroperitoneoscopic radical nephrectomy for large renal cell carcinoma in stage ct2 or ct3a is a feasible, safe and effective therapy option and if it shows any advantage regarding quality of life in comparison to open procedure. Methods: 23 patients who underwent RPNx for tumor size greater than 7cm (group 1) were matched and compared with 25 patients, who underwent ONx (group 2) for tumor with similar size characteristics. Patient and surgical data, QoL variables and complications were statistically analyzed. Results: The median followup was 12 (range: 6 18) months for both groups. Group 1 had significantly ( p < 0.001) less blood loss, shorter hospital stay, and shorter postoperative analgesic requirements. No conversion to open surgery was neccassary, and no major complications requiring an invasive intervention occurred. Retroperitoneoscopic patients had significantly better QoL and pain scores postoperatively to 6 months ( p < 0.001) and they return to baseline QoL status faster ( p < 0.001). Conclusions: RPNx for large RCC in stage ct2 or ct3a is a safe and efficacious procedure with good short-term outcome results and significantly shorter recovery of QoL variables. # 2005 Elsevier B.V. All rights reserved. * Corresponding author. Department of Urology and pediatric Urology, Northwest Hospital, Steinbacher Hohl 2-26, D Frankfurt am Main, Germany. Tel ; Fax: address: ebm_urology@gmx.de (W. Dillenburg) /$ see front matter # 2005 Elsevier B.V. All rights reserved. doi: /j.eururo

2 european urology 49 (2006) Introduction To date, fifteen years after the first report of laparoscopic radical nephrectomy (LNx) in 1991 [1], this procedure is routinely performed, transperitoneally or extraperitoneally, in several departments worldwide in selected patients with clinically ct1 renal cell carcinoma (RCC), in whom a nephronsparing surgery is not indicated [2 8]. During the last four years LNx using a retroperitoneoscopic approach (RPNx) has been established in our department as a standard treatment in selected cases with localized, in stage ct1, RCC. As our laparoscopic experience grows and convinced in the advantages of the extraperitoneal approach [9,10] we have extended the indications for RPNx to include clinically localized, bulky RCC in clinical stage ct2 or ct3a. However, only a few studies have examined the effectiveness and the oncological results of laparoscopy in the treatment of large RCC [11,12]. Furthermore, in this special patient group, the quality of life (QoL) has not been adequately evaluated in comparison to open radical nephrectomy (ONx) in order to support the indication of performing laparoscopy in cases of large RCC. Our aim was to evaluate the safety and the efficacy of RPNx for RCC >7 cm in size and compare it with those of ONx for tumors with similar size characteristics. In addition, we prospectively compared postoperative recovery and QoL issues in both patient groups. 2. Patients and methods From February 2001 to March 2005, 23 patients, who underwent RPNx for tumors >7 cm (group 1) having a clinical stage ct2 or ct3a, were matched and compared with 25 patients, who underwent ONx (group 2) for tumors with similar size characteristics. The design of the study was prospective, nonrandomized. The decision to perform RPNx or ONx was based mainly on surgeon s and patients preference after detailed information about the risk of each procedure and taking in account the lack of adequate international laparoscopic experience in cases of bulky RCC. Furthermore, patient size, anesthetic risks (i.e. severe chronic obstructive lung disease, etc) and the availability of the laparoscopic surgeon (a single surgeon [VP] performed all the RPNx) influenced decision for ONx or RPNx. Tumor localisation (central, peripheral, etc) had no impact on the operative approach. For the ONx, a standardized extraperitoneal flank incision was performed without rib resection [13]. The laparoscopic surgeon has a moderate experience (performing routinely difficult laparoscopic procedures) [14] at the beginning of RPNx for bulky RCC. Three senior surgeons with experience in open renal surgery (each one had over 150 ONx as first surgeon) performed the ONx (VP performed 9, UW 8, and EB 8 cases; the tumor characteristic distribution was similar between the surgeons). All the patients signed an informed form. Our Institutional Internal Board committee was informed about our study and accepted the performance of it. The renal mass was measured on computerized tomography (CT), and tumor size was defined by the largest diameter. No patient had evidence of metastatic disease. All patients had a normal contralateral kidney and no history of other malignancy. Patients with renal vein or cava thrombus and enlarged retroperitoneal lymph nodes were excluded. For the laparoscopic procedure a standardized technique [15] was used. The specimen was placed in a commercially available, entrapment sac (Lap Sac, Cook Urological Inc, Spencer, IN, USA) and extracted intact without morcellation, by extending the trocar incision in a form of a modified extraperitoneal Gibson s incision. Adrenalectomy was performed routinely. Renal hilus lymphadenectomy was performed if intraoperative inspection showed suspicious nodal enlargement. Operative time (OT) was recorded from the initial skin incision to the end of wound closure. The preoperative preparations were similar for both groups. According to the degree of severity, intraoperative complications were classified as major, moderate, and minor [16]. Early postoperative complications were defined as complications during the first 30 days after surgery. Late postoperative complications were defined, as those after 30 days. Postoperative analgesia was measured from the daily dose of opiates and the time of taking fluids. The preoperative evaluation and the postoperative followup were performed according to the guidelines of European Association of Urology [17]. Only patients with a followup of at least 6 months were included. Health-related quality of life (QoL) was evaluated using the European Organization for Research and Treatment of Cancer QLQ-C30 (version 3.0) questionnaire [18]. The QLQ-C30 questionnaire is validated in the German population [19] and used in German patients suffering from RCC [20]. For pain and satisfaction (regarding satisfaction for cosmetic and operation decision) assessment, the visual analog scale (VAS) was used rating from 0 (no pain or completely unsatisfied, respectively) to 10 (excruciating pain or fully satisfied, respectively). The activity assessment questions were addressed: need of pain medication, eating a normal diet, walking, ability to drive, to work, to do housework or hobby (i.e. garden) activities, and general impression of activity level (bedrest or full activity). Each activity item assessment was also based on a VAS rating from 0 (no activity, bedrest) to 10 (full activity). All questionnaires were self-administered preoperatively and at 1, 3 and 6 months postoperatively. Additionally for the pain assessment, the pain scale was self-administered on days 1, 3, 7, 30, and on day of discharge home. For QLQ-C30, norm-based and z-scores were used to compare patients with age and sex-matched normative data for the German general population [19]. Mean values and 95% confidence intervals were used to document differences between the groups [21]. Effect sizes (ES) [22] were calculated to verify significant differences in time. Postoperative QoL and pain scores were compared using analysis of covariance [23,24] with the baseline preoperative score as a covariante,

3 316 european urology 49 (2006) after the assumption of normality, the homogeneity of variances was assessed with the Levene s test [25]. For continuous variables, the Student-t-test or the Wilcoxon rank-sum-test, depending on distribution of data, were used. For categorical variables, the chi-square or the Fisher s exact-test were applied. Using survival analysis and the logrank test, the times required by patients to return to 75% of their baseline QoL score after nephrectomy was calculated. Commercially available statistical software was used. A p < 0.05 was considered statistically significant. 3. Results Patient and tumor characteristics are summarized in Table 1. No statistically significant ( p > 0.05) differences were noted between the two groups. Surgical data are shown in Table 2. Although the mean specimen weight was not significantly different, the estimated blood loss, the postoperative analgesia and the hospitalization were lower in the retroperitoneoscopic group. All RPNx were successfully completed without conversion to open surgery. No major or moderate intraoperative complications occurred. Postoperatively, two patients after ONx (8%) developed symptomatic pneumothorax requiring chest tube insertion. In both groups, the peritoneal injuries were accidental. There was no excessive tumor adhesion to peritoneum or colon making peritoneal injuries unavoidable. In retroperitoneoscopic group, the peritoneal injuries were left untreated, while in ONx group they were sutured primarily. Since the tumor location (central, peripheral, etc.) was equally distributed between the groups, it seems that tumor location has no impact on the choice of procedure. Because in ONx the peritoneal injury was more frequent and severe Table 1 Patient and pathological characteristics of the two patient group after retroperitoneoscopic (RPNx) and open radical nephrectomy (ONx) for large (>7 cm) renal tumors Characteristics Group 1 (n = 23) RPNx Group 2 (n = 25) ONx p Value No. pts Age (mean SD, years) Body Mass Index (mean SD, kg/m 2 ) Sex (n, %) Men 14 (61%) 14 (56%) Women 9 (39%) 11 (44%) ASA score (mean SD) Tumor size (mm, mean SD) Specimen weight (g, mean SD) Tumor side (n, %) Right 10 (43%) 12 (48%) Left 13 (57%) 13 (52%) Tumor location (n, %) Upper pole 5 (22%) 6 (24%) Middle zone (central, exophytic) 5 (22%) 6 (24%) Lower pole 7 (30%) 8 (32%) Central, endophytic, (hilar) 6 (26%) 5 (20%) Clinical stage (n, %) ct2 16 (70%) 17 (68%) ct3a 7 (30%) 8 (32%) cm 0 0 Pathological stage (n, %) pt2 12 (52%) 13 (52%) pt3a 6 (26%) 6 (24%) pt3b 5 (22%) 6 (24%) Positive surgical margins 0 0 Metastatic adrenal involvement (n, %) 1 (6%) 1 (5%) Pathological subtype of RCC (n, %) Clear cell 16 (70%) 18 (72%) Chromophobe 2 (8%) 2 (8%) Papillary 5 (22%) 5 (20%) Local recurrence (n, %) 0 0 : not significant; ASA: American Society for Anesthesiology.

4 european urology 49 (2006) Table 2 Surgical characteristics and complications of retroperitoneoscopic (RPNx) and open radical nephrectomy (ONx) for large (>7 cm) renal tumors Surgical characteristics and complications Group 1 (n = 23) RPNx Group 2 (n = 25) ONx p Value Operative time (minutes, mean SD) <0.001 First 10 cases <0.001 Last 10 cases Anesthesia time (minutes, mean SD) <0.001 Hospitalization time (days, mean SD) <0.001 Incision length (cm, mean SD) <0.001 Mean estimated blood loss (ml, mean SD) <0.001 Blood transfusion (n, %) 3 (13%) 10 (40%) <0.001 Minor intraoperative complications (n, %) 12 (52%) 37 (100%) <0.001 Pleura injury 0 12 (43%) Peritoneum injury 11 (48%) 18 (72%) Spleen capsular injury 0 2 (8%) Iatrogenic rib fracture 0 2 (8%) Renal vein/vena cava injury 1 (4%) 3 (12%) Minor early postoperative complications (n, %) 8 (35%) 23 (92%) <0.001 Prolong paralytic ileus 1 (4%) 5 (20%) Pneumothorax 0 2 (8%) Wound infection/secondary wound healing 0 1 (4%) Subcutaneous hematoma 4 (17%) 7 (28%) Subdiaphragmatic hematoma 1 (4%) 4 (16%) New onset of cardiac arrhythmia 1 (4%) 1 (4%) Pneumonia 1 (4%) 3 (12%) Late postoperative complications (n, %) 1 (4%) 9 (36%) <0.001 Incisional hernia 0 2 (8%) Chronic scar pain 1 (4%) 5 (20%) Permanent flank bulge 0 2 (8%) : not significant. and statistically required more doses of opiates ( p < 0.05) these patients suffered significantly ( p < 0.05) from prolonged paralytic ileus. Surgical margins were tumor-free in both groups. No patient had local lymph node metastasis. The mean followup time for RPNx and ONx group was 12 (range: 6 18) and 13 (range: 6 19) months, respectively. During this time, no local recurrence was observed. Of the 25 patients, who underwent ONx, multiple metastatic foci developed in the lung in one patient (4%) with pt3a tumor sixteen months postoperatively. At the last followup examination, eighteen months postoperatively, the patient was in good physical condition (Karnofsky performance status 80%) receiving immunotherapy. No patient from the RPNx group developed metastases. The baseline unadjusted and norm-based scores of QLQ-C30 were compared among patients undergoing RPNx and ONx. The mean norm-based scores for each domain were within 1 standard deviation (SD) of the norms for the German general population (data not shown). Thus, the overall reported QoL of our patients in each domain was comparable to an age and sex-matched comparison group in the German general population. The retroperitoneoscopic patients show significantly ( p < 0.05) higher QoL scores during each of followup time (at 1-month, 3-month, 6-month, and 1-year postoperative examination) than the ONx group at each time. In the analysis of covariance, the differences between the RPNx and ONx patients were more pronounced (Fig. 1). Patients after RPNx Fig. 1 Analysis of covariance ( p < 0.001) for visual analog score (VAS) of pain after retroperitoneoscopic (RPNx) and open radical nephrectomy (ONx).

5 318 european urology 49 (2006) Table 3 Recovery parameters of retroperitoneoscopic (RPNx) and open radical nephrectomy (ONx) for large (>7 cm) renal tumors Group 1 (n = 23) RPNx (mean SD) Group 2 (n = 25) ONx (mean SD) p Value Analgesic requirement (mg of morphine equivalents) <0.01 Postoperative analgesia (hours) <0.01 Time to oral intake (hours) <0.01 Mean time to regular diet (days) <0.01 Return to non-strenuous household activities (days) <0.01 Return to normal household activities (days) <0.01 Return to part-time work (days) <0.01 Return to full-time work (days) <0.01 Return to 100% normal health (days) <0.01 Number of medical visit (n) <0.01 : not significant. show consistently significantly better QoL and pain scores from hospital discharge to 6 months postoperatively ( p < 0.001). All the recovery parameters after RPNx returned significantly ( p < 0.01) faster to baseline status in comparison to those after ONx (Table 3). Seven and eleven of the total 15 domains of QLQ- C30 registered significant declines (ES > 0.2) at 1 month in patients after RPNx and ONx, respectively, with the greatest deterioration registered by the Role functioning and Pain (ES: 0.69 and +0.66, respectively) in ONx group (Table 4). By 6 months, Role functioning and Pain remained significantly worse than baseline (ES: 0.21 and +0.20, respectively) in patients underwent ONx, whereas the scores of all the scales were same as their baseline values in patients after RPNx. Patients after ONx showed significant score changes (ES > 0.2) at 6 months in more scales of VAS of Pain than patients, who underwent RPNx (2 versus 0). Six months after RPNx, the scores of all the pain subscales returned approximately to their baseline (ES < 0.2). The mean time required for patients after RPNx to return to at least 75% of their baseline QoL scores Table 4 Significant changes in quality of life (QoL) instruments during the follow-up period (only subscales with effect size [ES] >0.2 listed) after retroperitoneoscopic (RPNx) and open radical nephrectomy (ONx) for large (>7 cm) renal tumors Group 1 (n = 23) RPNx Group 2 (n = 25) ONx p Value * Pretreatment Mean (SD) 1-Mo ES 6-Mo ES Pretreatment Mean (SD) 1-Mo ES 6-Mo ES EORTC QLQ-C30 Physical functioning 84 (22) * 82 (23) * <0.001 Role functioning 83 (20) * 85 (25) * <0.001 Emotional functioning 84 (17) * 82 (19) * <0.001 Social functioning 91 (20) (22) Global quality of life 74 (21) * 76 (23) * Fatigue 17 (15) (17) Nausea and vomiting 3 (2) (2) Pain 20 (15) * 19 (14) * <0.001 Dyspnea 7 (8) (10) Sleep disturbance 7 (9) (8) Appetite loss 8 (5) (6) Visual analog pain score Flank pain 1.5 (1.1) * 1.4 (1.0) * <0.001 Abdominal pain 1.1 (1.2) (1.5) Overall 1.3 (1.4) * 1.1 (1.2) * <0.001 Interfering with moving or walking 1.6 (1.5) * 1.4 (1.2) * <0.001 Interfering with work or daily activities 1.4 (1.1) * 1.3 (1.4) * Overall disturbance by pain 1.3 (1.2) * 1.4 (1.3) * <0.001 The ES was calculated by divided the observed differences in mean scores at two different time points by the SD of the first time point: ES = mean time point 2 mean time point 1 standard deviation of time point 1. An effect size (ES) <0.2 means no change, and an ES of , , and >0.8 indicate little, moderate, and large changes, respectively. Mo: Months; SD: Standard Deviation. * Changes between the RPNx and ONx patient group at 6 months.

6 european urology 49 (2006) Fig. 2 Comparison of Kaplan-Meier curves of time to return to 75% of preoperative quality of life score (log rank test, p < 0.001) between open surgical (ONx) and retroperitoneoscopic radical nephrectomy (RPNx). were 50.4 (SD: 39.8) days as compared to 99 (SD: 45.9) for the ONx patients ( p < 0.001, Fig. 2). Performing a multivariate analysis only body mass index (BMI) and co-morbidity, estimated by ASA score [4], had an impact on postoperative recovery; patients with greater BMI and higher ASA score recover significantly more slowly after surgery ( p = and p = 0.014, respectively). Contrarily, age, gender, side of surgery, size and location of tumor were not statistically significant ( p > 0.05) in predicting postoperative QoL scores. At 6-month follow-up, the mean overall satisfaction was significantly higher in RPNx than those after ONx ( versus , respectively, p = 0.025). Similarly, the mean cosmetic satisfaction score significantly favored the retroperitoneoscopic group ( versus , respectively, p = 0.012). 4. Discussion Our study is unique. It is a prospective, nonrandomized, comparative assessment between RPNx and ONx in patients with RCC >7 cm in size and at stage of ct2 or ct3a. Not only the surgical feasibility and the short-term oncologic efficacy but also the health-related QoL and reconvalescence were evaluated in order to assess the advantages of performing RPNx in this patient group. Although the long-term oncologic outcome of RPNx in patients with RCC >7 cm in size was not the primary end-point of our study, the surgical margins of dissected specimens were tumor-free in all patients. Thus, RPNx appears to be of equal oncologic efficacy with ONx. However, the findings of Cleveland Clinic [11], showed similar results after LNx for T1 tumors (median size 4.5 cm) and for T2 tumors (median size 9.2 cm). They concluded that LNx could be performed retroperitoneoscopic or transperitoneal for T2 tumors. Although in 2 cases positive margins were found in T2 tumors after LNx, this was not significantly different from the group of T1 and T2 tumors, which were treated by open surgery. Portis et al. [6] reported a 92% recurrencefree survival at five years for tumors >7 cm after LNx. In a retrospective study of Dunn et al. [12], a comparison was performed between LNx and ONx. They have expanded the indications for LNx to include tumor size up to 10 cm, which is approximately double in size from the accepted size limit, which is suggested by other laparoscopic surgeons [4]. In concordance to others [11,12], we found that in comparison to ONx, in patients with RCC >7 cm and at clinical stage of ct2 or ct3a, RPNx is associated with a lower complication rate. Retroperitoneoscopic procedures were tolerated better than ONx with significant decrease in postoperative analgesia, time to oral intake, hospitalization and postoperative complications. Although, in the retroperitoneoscopic group the OT was significantly longer, our average time is in accordance with previously published data [4]. Like others [12], our experience showed that OT has decreased by nearly half when comparing the first and last 10 patients, although we actually reduced our retroperitoneoscopic time to that of our standard open times. However, the OT of RPNx cannot be directly compared with those of ONx. The open surgeons had significantly greater experience with ONx, since the retroperitoneoscopic surgeon has improved his technique and learning curve. Nevertheless, LNx seems to be less stressful than ONx for the patient [26]. Two special issues must be underlined in our laparoscopic practice, namely the avoidance of morcellation and the preference of retroperitoneoscopic approach. Since the value of morcellation is not adequately evaluated in large tumor masses [11] and because we had no experience with this method of specimen entrapment, it was reasonable for us to prefer intact specimen extraction. Using morcellation, shorter hospitalization and decrease of postoperative analgesia were reported [27]. Without performing any comparative study between patients with different tumor size and without evaluating the re-convalescence with any validated health-related QoL-questionnaire, Abbou et al. [4] suggested that the laparoscopic approach should be

7 320 european urology 49 (2006) restricted to tumors less than 5 cm in size, because the removal of larger tumors would required a longer incision, negating the advantages of laparoscopy. Our study shows that the incision size after RPNx is significantly smaller than those after ONx, and approximately half the size. Furthermore, in RPNx, the intercostal flank incision is avoided and the specimen is removed via a smaller modified Gibson s incision sparing the cutaneous and muscles nerves. Since almost 50% of patients experience a symptomatic flank bulge following a flank incision after ONx for renal tumor [28], and the morbidity of flank incision is well documented in the literature [29], this observation together with our prospective comparative data supports the shift towards LNx even in cases of large RCC. Numerous studies [30,31] have confirmed that RPNx is a safe and efficient procedure. In a recent prospective randomized controlled study comparing the transperitoneal with the retroperitoneoscopic nephrectomy in patients having renal tumor smaller than 4.6 cm in size both approaches were similar regarding the morbidity and the technical difficulty for the surgeon [30]. Another prospective randomized comparison of retroperitoneal versus transperitoneal LNx revealed that retroperitoneal approach was associated with shorter time to access renal vessels, and shorter total OT. However, in this study, Desai et al. [32] found that the transperitoneal and retroperitoneal approaches were similar in terms of estimated blood loss, hospital stay, intraoperative complications, postoperative complications and postoperative analgesia requirements [32]. Contrarily, Ono et al. [33] in a non-randomized study comparing 6 RPNx versus 32 transperitoneal LNx found that retroperitoneal approach has less blood loss, shorter operative and lower incidence of complications than transperitoneal one. However, because of the great bias of this study the results are questionable. Matin and Gill [34], reviewed the worldwide experience in LNx. They found that convalescence was longer in transperitoneal than in retroperitoneal approach. Since tumor size is no longer a limiting factor to perform laparoscopic surgery, for many surgeons the most important factor is to make this technique simpler. Thus, the transperitoneal route is probably the best approach, because it gives more working space. However, in concordance to others [7,11], we found no limitations in performing RPNx even for large tumors. Contrarily, the advantage of the direct approach to the renal vessels and the avoidance of the peritoneal complications (ileus, bowel injury, etc) that offers the retroperitoneal approach could compensate the relatively limited working space. Even if, the working space in RPNx is limited we did not have difficulties to use the organ bag. Like others [7,11], our exclusion criteria for RPNx were tumor thrombus involving the vena cava, bulky lymphadenopathy, or extensive involvement of adjacent structures. However, since in 25% of patients a vena renalis thrombus was found in the histological specimen, RPNx for stage pt3b RCC seems to be feasible and safe. We believe that the size of the tumor is not a contraindication for RPNx. However, adequate laparoscopic experience is necessary. Health-related QoL was extensively evaluated between open and laparoscopic procedure only in donor nephrectomy patients, showing a clear advantage of the laparoscopic approach [35,36]. However, this is a special patient group having no significant co-morbidity, normal kidney size, and the operation was not performed according to oncologic principles. Our study shows that patients who underwent RPNx for large RCC clearly benefited in terms of convalescence. The QLQ-C30 and the VAS favored the retroperitoneoscopic group in a statistically significant manner in the majority of the domains. Like others [35,36], it was not surprising that pain was one of the subscales with the highest p value favoring the RPNx. Our study has several limitations. It is not randomised and the decision criteria for open or retroperitoneoscopic procedure were arbitrary. However, the characteristics of renal tumors between the two groups were similar. The ONx were performed by three surgeons, the RPNx were performed by a single laparoscopic surgeon. Although patients with clinical stage ct3b were primarily excluded from the study, 25% of the patients with bulky renal tumor in clinical stage ct2 or ct3a had actually a pathological stage pt3b with renal vein thrombus. Furthermore, our mean followup of (range: 6 19) months is quite short. Since, only for small RCC, it is clearly established 7 that after a median followup of 5 years the oncological results between open or laparoscopic surgery are equivalent, at least the same followup period is mandatory for large non-metastatic tumors to assess comparative oncological outcome. 5. Conclusions The RPNx for large renal tumors is a challenging operation. The RPNx is a safe and effective alternative having fewer complications and shorter hospitalization. Although the retroperitoneal space is limited, this procedure has the advantage of minimizing the trauma of peritoneal cavity, and avoidance of extensive mobilization of abdominal

8 european urology 49 (2006) organs, while meeting the standards of cancer surgery. Patients undergoing RPNx experience better QoL and pain scores up to 6 months postoperatively than ONx patients. However, additional prospective randomized studies with longer follow-up and larger patient numbers are mandatory. References [1] Clayman RV, Kavoussi LR, Soper NJ, Dierks SM, Meretyk S, Darcy MD, et al. Laparoscopic nephrectomy: initial case report. J Urol 1991;146: [2] Chan DY, Cadeddu JA, Jarret TW, Marshall FF, Kavoussi LR. Laparoscopic radical nephrectomy: cancer control for renal cell carcinoma. J Urol 2001;166: [3] McDougall EM, Clayman RV, Elashry OM. Laparoscopic radical nephrectomy for renal tumor: the Washington University experience. J Urol 1996;155: [4] Abbou CC, Cicco A, Gasman D, Hoznek A, Antiphon P, Chopin DK. Retroperitoneal laparoscopic versus open radical nephrectomy. J Urol 1999;161: [5] Gasman D, Saint F, Barthelemy Y, Antiphon P, Chopin DK, Abbou CC. Retroperitoneoscopy: a laparoscopic approach for adrenal and renal surgery. Urology 1996;47: [6] Portis AJ, Yan Y, Landman J, Chen C, Barret PH, Fentie DD, et al. Long term follow up after laparoscopic radical nephrectomy. J Urol 2002;167: [7] Allan JD, Tolley DA, Kaouk JH, Novick AC, Gill IS. Laparoscopic radical nephrectomy. Eur Urol 2001;40: [8] Wille AH, Roigas J, Deger S, Tullmann M, Turk I, Loening SA. Laparoscopic radical nephrectomy: techniques, results and oncological outcome in 125 consecutive cases. Eur Urol 2004;45: [9] Poulakis V, Dillenburg W, Moeckel M, de Vries R, Witzsch U, Zumbe J, et al. Laparoscopic radical prostatectomy: prospective evaluation of the learning curve. Eur Urol 2005;47: [10] Hoznek A, Salomon L, Gettman M, Stolzenburg JU, Abbou CC. Justification of extraperitoneal laparoscopic access for surgery of the upper urinary tract. Curr Urol Rep 2004;5:93 9. [11] Steinberg PA, Finelli A, Desai MM, Abreu CS, Ramani PA, Spaliviero M, et al. Laparoscopic radical nephrectomy for large (Greater than 7 cm, T2) renal tumors. J Urol 2004;172: [12] Dunn MD, Portis AJ, Shalhav AL, Elbahnasy AM, Heidorn C, McDougall EM, et al. Laparoscopic versus open radical nephrectomy: a 9-year experience. J Urol 2002;164: [13] Witzsch U, Humke U, Kollias A, Becht E. Organerhaltende Nierenchirurgie-Werkbankchirurgie und Autotransplantation. In: Schreiter F, editor. Plastische-Rekonstruktive Chirurgie in der, Urologie. Stuttgart: Thieme; p [14] Guillonneau B, Abbou CC, Doublet JD, Gaston R, Janetschek G, Mandressi A, et al. Proposal for a European Scoring System for Laparoscopic Operations in Urology. Eur Urol 2001;40:2 7. [15] Gill IS, Rassweiler JJ. Retroperitoneoscopic renal surgery: our approach. Urology 1999;54: [16] Vallancien G, Cathelineau X, Baumert H, Doublet JD, Guillonneau B. Complications of transperitoneal laparoscopic surgery in urology: review of 1,311 procedures at a single center. J Urol 2002;168:23 6. [17] Mickisch G, Carballido J, Hellsten S, Schulze H, Mensink H. European Association of Urology. Guidelines on renal cell cancer. Eur Urol 2001;40: [18] Fayers P, Weeden S, Curran D, EORTC Quality of Life Study Group. EORTC QLQ-C30 Reference Values. Brussels: EORTC Data Center; [19] Schwarz R, Hinz A. Reference data for the quality of life questionnaire EORTC QLQ-C30 in the general German population. Eur J Cancer 2001;37: [20] Lummen G, Schenck M, Borgermann C, Eisenhardt A, Vom Dorp F, Sperling H, et al. Inhaled immunotherapy for pulmonary metastases of renal cell cancer. Urologe A 2004;43: [21] Gardner MJ, Altman DG, editors. Statistic with Confidence-Confidence intervals and statistical guidelines. London: B.M.J., The University Press; [22] Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health related quality of life scores. J Clin Oncol 1998;16: [23] Analysis of Covariance. Post Hoc Statistical Procedures: [24] Paul-Dauphin A, Guillemin F, Virion JM, Briancon S. Bias and precision in visual analogue scales: a randomized controlled trial. Am J Epidemiol 1999;150: [25] Levene Test for Equality of Variances. In: Engineering Statistics Handbook. handbook/eda/section3/eda35a.htm. [26] Miyake H, Kawabata G, Gotoh A, Fujisawa M, Okada H, Arakawa S, et al. Comparison of surgical stress between laparoscopy and open surgery in the field of urology by measurement of humoral mediators. Inter J Urol 2002;9: [27] Walther MM, Lyne JC, Libutti SK, Linehan WM. Laparoscopic cytoreductive nephrectomy as preparation for administration of systemic interleukin-2 in the treatment of metastatic renal cell carcinoma: a pilot study. Urology 1999;53: [28] Chatterjee R, Nam R, Fleshner N, Klotz L. Permanent flank bulge is a consequence of flank incision for radical nehrectomy in one half of patients. Urol Oncol 2004;22: [29] Kumar S, Duque JL, Bae R, O Leary MP, Loughlin KR. Morbidity of flank incision for renal donors. Transplant Proc 2000;32: [30] Nambirajan T, Jeschke S, Al-Zahrani H, Vrabec G, Leeb K, Janetschek G. Prospective, randomized controlled study: transperitoneal laparoscopic versus retroperitoneoscopic radical nephrectomy. Urology 2004;64: [31] Gill IS, Schweizer D, Hobart MG, Sung GT, Klein EA, Novick AC. Retroperitoneal laparoscopic nephrectomy: The Cleveland Clinic Experience. J Urol 2000;163: [32] Desai MM, Strzempkowski B, Matin SF, Steinberg AP, Ng C, Meraney Am, et al. Prospective randomized comparison

9 322 european urology 49 (2006) of transperitoneal versus retroperitoneal laparoscopic radical nephrectomy. J Urol 2005;173: [33] Ono Y, Ohshima S, Hirabayasi S, Hatano Y, Sakakibara T, Kobayashi H, et al. Laparoscopic nephrectomy using a retroperitoneal approach: comparison with a transabdominal approach. Int J Urol 1995;2:12 6. [34] Matin SF, Gill IS. Laparoscopic radical nephrectomy: retroperitoneal versus transperitoneal approach. Curr Urol Rep 2002;3: [35] El-Galley R, Hood N, Young CJ, Deierhoi M, Urban DA. Donor nephrectomy: a comparison of techniques and results of open hand-assisted and full laparoscopic nephrectomy. J Urol 2004;171:40 3. [36] Buell JF, Lee L, Martin JE, Dake NA, Cavanaugh TM, Hanaway MJ, et al. Laparoscopic donor nephrectomy vs. open live donor nephrectomy: a quality of life and functional study. Clin Transplant 2005;19: Editorial Comment H. Van Poppel, B. Van Cleynenbreugel, Leuven, Belgium hendrik.vanpoppel@uz.kuleuven.ac.be (H. Van Poppel) Ben.VanCleynenbreugel@uz.kuleuven.ac.be (B. Van Cleynenbreugel) In contrast to our general and gynaecological colleagues, the Urologic Community has been slow and reluctant to adapt laparoscopy as a therapeutic tool in our treatment armatory. The first laparoscopic nephrectomy by Clayman and co-workers in 1991 was a milestone in the embracement of laparoscopy. Not only did it proved the feasibility of performing urological extirpative surgery through a minimally invasive approach. It also clearly demonstrated the advantages of this approach: smaller surgical and psychological operative trauma, less need for postoperative analgesia, faster postoperative recovery, shorter hospitalisation and earlier return to work. In short, a higher quality of life for the patient. Initially, the laparoscopic removal of kidneys was reserved for benign lesions. With growing experience, the treatment of kidney cancer was included in this treatment modality. Nowadays, laparoscopic radical nephrectomy is the standard care for a kidney tumor in whom nephron-sparing surgery is not indicated. There has been some debate whether or not the laparoscopic approach should be reserved for smaller kidney tumors (smaller than 5 cm diameter). The underlying idea is that the removal of larger kidney tumors would require a larger incision and thus negating the advantages of laparoscopy. The authors of this article very nicely demonstrate that this is not the case. The advantages of laparoscopic surgery remain, even for tumors bigger than 7 cm in diameter. Rightfully so, the authors do not advocate morcellation of the specimen. The extract the specimen intact. Although morcellation would allow for an even smaller extraction incision, the potential adverse effects do not justify this procedure when one is treating cancer. Besides the possibility of tumor seeding in case of sac rupture, there is also the difficulty (and indeed almost impossibility) for the pathologist to correctly stage and classify the resected tumor. We believe that a non muscle splitting incision is one of the keys for low postoperative pain and early reconvalescence. In our experience, a pfannenstiel incision is preferable over a lower- or upper-midline incision. Although this requires a repositioning of the patient and slightly prolongs the operative time, it is less painful and leads to a speedier recovery of the patient. As we now all know, tumor size in itself is not really a limiting factor for a laparoscopic approach. However, tumor location remains an important factor. It would be unwise to attempt a laparoscopic removal of even a small, but intra-hilar located tumor. The same is true for a tumorthrombus that extents into the vena cava. Although feasible, it is unnecessary dangerous and in this case, an open approach is favourable. The same is true for the rare, giant bulky kidney tumor that would require an extensive incision to remove it intact. With this in mind, it s important that urologist in training not only focussed on training in minimally invasive surgery, and also acquires the necessary open skills to become a complete urologist. Editorial Comment Ziya Kirkali, Izmir, Turkey ziya.kirkali@deu.edu.tr This is a timely paper looking at the feasibility of retroperitoneoscopic radical nephrectomy (RPNx) in large (>7 cm) renal cell carcinoma (RCC). In a prospective non randomized fashion, they have treated 23 patients with RPNx and 25 patients with open radical nephrectomy (ONx) within 4 years. They have found less blood loss, shorter hospital stay, shorter post-operative analgesics use, better quality of life (QoL), pain scores and earlier return to baseline QoL in the patients treated by RPNx. They conclude that RPNx for large T2 and T3a RCC is safe and efficacious with shorter recovery of QoL.

10 european urology 49 (2006) Laparoscopic/retroperitoneoscopic radical nephrectomy has been a well-established method of treating localized RCC. Since its first introduction 15 years ago, many series confirmed its efficacy and safety [1]. However, like many other urological surgical procedures there is no prospective randomized study with enough statistical power to show similar oncological outcome after ONx and laparoscopic/retroperitoneoscopic radical nephrectomy. As more experience gathered in laparoscopic radical nephrectomy for small tumors; it was recognized that in fact most of these tumors are candidates for nephron sparing surgery and thus radical treatment was indeed an over-treatment. This prompted many minimal invasive urological surgeons to focus on laparoscopic partial nephrectomy. Others felt that they could safely perform minimal invasive surgery for larger and more advanced tumors. The authors of this paper must be congratulated for assessing various issues apart from safety and efficacy including quality of life, pain and reconvalescence in patients undergoing RPNx and ONx. There is no doubt QoL, pain and convalescence issue are not ony important for the patient but also implicates health costs to the society. One must keep in mind that this study is only involving 48 patients and thus far from being powerful to draw any solid conclusions. One other drawback is that the patients were not randomized, and despite similar tumor characteristics bias was inevitable. All RPNx was performed by one surgeon whereas 3 different surgeons performed the ORNx. We know that quality of surgery is not only an important determinant of oncological outcome, but also may play an important role in QoL and pain [2]. I also find 40% blood transfusion rate, 100% minor intraoperative complication rate, 92% minor post-operative complication rate and 36% late post-operative complication rate rather high for the patients undergoing open RNx. Today radical nephrectomy is a quite safe operation with less morbidity [3]. Laparoscopic urology and minimal techniques are increasingly used today in the treatment of solid renal masses. These approaches certainly provide les morbidity and better return to activity. The oncological urologists should aim at first curing their patient from their disease and secondly to provide a higher QoL. In this respect RPNx will certainly play a role in a subset of selected patients with large T2 T3 tumors. However, before embarking on to accept this approach as the standard of care, it is the duty of the scientific world to conduct well-designed prospective randomized studies with enough statistical power. Only in this way we can give the answer to the question whether RPNx is equivalent to open RN or not. References [1] Permpongkosol S, Chan DY, Link RE, Jarret TW, Kavoussi LR. Laparoscopic radical nephrectomy: long-term outcomes. J Endourol 2005;19: [2] Kirkali Z, Van Poppel H, Tuzel E, Mungan U, Newling DW, Jacqmin D, and members of the EORTC GU Group. A prospective survey of surgical approaches in clinically localized renal cell carcinoma - A preliminary attempt at surgical quality control. Uro Oncology 2002;2: [3] Corman JM, Penson DF, Hui K, Khuri SF, Daley J, Henderson W, et al. Comparison of complications after radical and partial nephrectomy: results from the National Veterans Administration Surgical Quality Improvement Program. BJU International 2000;86:782 9.