Japanese Journal of Clinical Oncology 34:274-279 (2004)
© 2004 Foundation for Promotion of Cancer Research
Early and Late Complications of Radical Retropubic Prostatectomy: Experience in a Single Institution
Department of Urology, Sapporo Medical University, Sapporo, Japan
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONSUBJECTS AND METHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Background: Radical retropubic prostatectomy is one of the first-line treatments for clinically organ-confined prostatic cancer. However, some studies have reported the morbidity of this procedure. We retrospectively assessed the incidence of complications of radical retropubic prostatectomy in our institution.
Methods: We reviewed 123 consecutive medical charts of prostate cancer patients who underwent radical retropubic prostatectomy between 1988 and 2001 at our institution. We evaluated intraoperative complications, early complications within 1 month postoperatively, and late complications, including anastomotic stricture and urinary incontinence.
Results: The median age of patients was 66 years (range, 53 to 74 years) and median follow-up duration was 44.0 months (range, 2 to 157 months). None of the patients died due to surgery-related causes. Intraoperative complications included rectal injuries in six patients (4.9%) and ureteral injury in one patient (0.8%). As for late complications, anastomotic strictures were observed in 16 patients (13.8%), and stress urinary incontinence that persisted for more than 12 months was observed in 13 patients. The estimated continence recovery rate at 12 months was 87.3%. Multivariate analysis did not reveal any predictive factor for anastomotic stricture. However, the blood loss volume and period of surgery were significant predictive factors of continence recovery.
Conclusions: Radical retropubic prostatectomy was safely performed, though there were various intra- or postoperative complications that were adequately managed. Early recovery of continence was related to the blood loss volume and the surgery period. Adequate surgical experience and a meticulous technique to avoid excessive bleeding are important factors for an early recovery.
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONSUBJECTS AND METHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Radical retropubic prostatectomy (RRP) is one of the first-line treatments for clinically organ-confined prostatic cancer. The 10-year cancer-specific survival rate of RRP was recently reported to be 90% (1). However, there are several reports on complications and adverse events related to the surgical procedure. The treatment is highly effective; therefore, patients usually enjoy long-term survival, indicating that the treatment should guarantee a high quality of life. Thus, it is important to clarify the incidence of complications associated with the treatment and its influence on the clinical course. With regard to intraoperative complications, blood loss during RRP has been the main issue since the introduction of this procedure. However, the development of the dorsal vein complex bunching technique enables the reduction of blood loss (2). Administration of autologous transfusion prevents the need for allogenic transfusion. On the other hand, late complications such as anastomotic stricture and stress urinary incontinence have not been completely eliminated, although there are some reports and speculations about their mechanisms (3–6). The aim of this study was to clarify the incidence of early and late complications of RRP at our institution, and to determine the predictive factors of late urinary complications.
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SUBJECTS AND METHODS |
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TOPABSTRACTINTRODUCTIONSUBJECTS AND METHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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For analysis in this study, we reviewed the clinical courses of 123 consecutive patients who underwent RRP between May 1988 and December 2001 at our institution. We evaluated intraoperative, early and late complications. Early complications were defined as those that developed within 1 month postoperatively, and late ones as those observed at least 1 month after operation. Of the 123 patients, seven were lost to follow-up. Thus, 116 patients were available for evaluating late complications. In this study, we focused on anastomotic stricture and urinary incontinence as late urinary complications. Another major complication, erectile dysfunction, will be reported elsewhere.
We determined the predictive factors of anastomotic stricture and urinary incontinence persisting for more than 12 months using multivariate analysis. Based on previously reported analyses, we chose the following factors: (1) age; (2) volume of blood loss; (3) period of the surgery (1988 to 1995 vs 1996 to 2001); (4) neoadjuvant hormonal therapy (yes vs no); (5) previous transurethral resection of the prostate (TURP) (yes vs no); (6) neurovascular bundle preservation (no vs yes) and (7) pathological stage (pT3 or more vs pT2). The surgery was divided into two periods because firstly, the ‘bunching technique’ was introduced in our institution in 1996. This technique might have enabled more precise, anatomical surgery to reduce the complications of RRP. Secondly, we started autologous blood preparation in 1996. The preparation might have affected decision-making by surgeons in various situations, including autologous as well as additional allogenic transfusion, thus generating different transfusion volumes in patients. We prepared the autologous blood before surgery with 400 ml for 16 patients, 600 ml for one, 800 ml for 55, 1000 ml for one and 1200 ml for nine. Of the 55 patients who prepared 800 ml or more for autologous transfusion, two required additional allogenic transfusion for blood loss of less than 2000 ml, and 14 for that of 2000 ml or more.
Preoperative serum PSA concentrations were measured by radioimmunoassay (Hybritech Inc., San Diego, CA). Clinical stages were based on the Japanese version of the TNM classification, advocated by the Japanese Urological and Pathological Associations (7). We used Stat View 5.0 (SAS Institute, Cary, NC) for statistical analyses. A P-value of <0.05 was considered statistically significant.
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RESULTS |
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TOPABSTRACTINTRODUCTIONSUBJECTS AND METHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Patients’ Demographics
Patients’ characteristics are shown in Table 1. Median age was 66 years (range, 53 to 74 years) and the median follow-up duration was 44 months (range, 2 to 157 months). Clinical stages of T1c and T2a each accounted for one-third of the total. Half of the patients had a preoperative serum PSA level of <10 ng/ml, with a median of 9.4 ng/ml. Neoadjuvant and adjuvant hormonal therapies were performed for 16 (13.0%) and 18 (14.6%) of the 123 patients, respectively; three among these underwent both types of adjuvant therapy. Patients were administered neoadjuvant hormone therapy at another institute. Five patients died of cancer. Cause-specific survival rates at 5 and 10 years were estimated to be 96.0% and 84.0% in the current population, respectively (Kaplan–Meier method). Twenty-three patients (18.7%) had a previous history of TURP. The neurovascular bundle was preserved in 81 patients (65.9%; unilaterally in 54, and bilaterally in 27), when patients wanted preservation that would not compromise cancer control.
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As for operators, chief residents of our institution performed most operations with the help of experienced surgeons. All procedures were performed with the retrograde approach that was introduced by Walsh et al. (8). The urinary tract was reconstructed with anastomosis of the urethra and bladder with 5 or 6 absorbable sutures. A 20 Fr. Foley catheter was indwelled for 2 weeks. However, in the recent series, we removed it at 1 week after surgery.
Intraoperative and Early Complications
The median volume of blood loss during surgery was 1700 ml, ranging from 360 to 6500 ml. The volume (1650 ml) in the 83 late patients (1996–2001) was significantly smaller than that (1900 ml) in the 40 early patients (1988–1995) (P < 0.007; Mann–Whitney U test). Intraoperative complications included rectal injuries in six patients (4.9%) and ureteral injury in one patient (0.8%) (Table 2). Rectal injuries were managed by the immediate closure of the rectum with simultaneous colostomy construction in three patients in the early series, and closure alone in three in the late ones. Ureteral injury was successfully treated with ureteroneocystostomy.
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Various early complications related to surgical procedures were observed within 1 month after surgery (Table 2). The most frequent complication was surgical site infection (SSI), which was observed in 17 (13.8%) patients. In most cases, the infections were superficial and did not need specific treatment (9). Only one patient with a deep infection required surgical drainage. Other early complications observed were anastomotic leakage in four patients that required prolonged drainage for more than 2 weeks, lymph drainage persisting for more than 2 weeks in six patients, lymphocele in one patient and a pelvic abscess not directly related to SSI in one patient. Early complications that were not directly related to the surgical procedure were observed in six patients, with the frequency of each being less than 2%. No patient died of surgery-related causes in the intraoperative or early postoperative period.
Late Complications
Late complications were evaluated in the 116 patients. Only when the patient complained of a weak urinary stream did we confirm the decreased urinary stream by uroflowmetry and post-void residual urine by ultrasonography. Subsequently, we performed retrograde urethrography to confirm anastomotic stricture in most of the patients with a weak urinary stream. Anastomotic stricture with poor urinary stream (<10 ml/s in Qmax or >100 ml post-void residual urine) was observed in 16 patients (13.8%). More than half of them occurred within 6 months after operation. Of the 16 patients with anastomotic stricture, 10 underwent endoscopic bladder neck incision with a cold knife, four underwent balloon dilation and two underwent dilation with metal sounds. Of the 10 patients who underwent bladder neck incision, eight were successfully treated. However, two developed stress urinary incontinence after incision. Another two patients needed repeat incision for recurrent stricture. Among the patients who underwent balloon dilation or metal sound dilation, one required periodic dilation. The overall success rate of a single treatment for anastomotic stricture was 75.5% (12 of 16 patients).
Multivariate analysis with the Cox proportional hazards model revealed that none of the factors were significantly involved in postoperative anastomotic stricture (Table 3). However, history of TURP was likely to be involved in this complication.
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Anterior urethral stricture, which might have been due to urethral manipulation such as urethral catheterization, was observed in two (1.7%) patients.
In this study, we defined ‘dry’ or ‘continent’ as when patients used no pads or just 1 pad in a day because many patients probably used a pad as a precautionary measure, despite their sufficient continence. Of the 103 patients who were followed up for more than a year, 90 regained continence within 6 months after surgery. Stress urinary incontinence that persisted for over 12 months was observed in 13 patients. Of the 116 patients, the estimated recovery rates of postoperative continence at 6 and 12 months by Kaplan–Meier method were 78.2% and 87.3%, respectively. Patients in the late series regained continence more rapidly than those in the early ones (Fig. 1, P < 0.001 by the log–rank test). The rate at 12 months after surgery was 94.7% in the late series and 69.7% in the early series.
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We evaluated the predictive factors of postoperative incontinence with multivariate analysis (Cox proportional hazards model). Less blood loss and recent surgical period were significant predictive factors for postoperative recovery of continence (Table 4). Figure 1 shows the continence recovery curve divided according to the surgery period using the Kaplan–Meier method, which supported the result of the analysis for its predictive factors.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONSUBJECTS AND METHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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The present study aimed at determining the incidences of early and late complications of RRP, and the predictive factors of late urinary complications. Various complications related to surgery have been observed in RRP, although life-threatening complications are rare (10). The incidence of intraoperative complications ranged from 0.8% to 3.7% (5,11), with rectal injury being predominant, ranging from 0.5% to 2.1% (5,6,11,12). Arai et al. reported that the rate was 3.0% in their cooperative study of 633 Japanese patients who received RRP (10). In our series, the rate of this complication was 4.9%, which is slightly higher than that in their study. This was partly due to technical immaturity that could be eliminated by enhanced surgical experience. Fortunately, this complication in the recent three of the six patients was managed during surgery with closure alone.
Blood loss has been the main complication associated with RRP. Although the volume of blood loss in our series was higher than that of other studies, it was significantly smaller in the late series than in the early one—a tendency similar to previous studies (11). In our late series from 1996, the introduction of the bunching technique might have contributed to the reduction of blood loss. Efforts to reduce the volume of blood loss may be a key factor to prevent possible early complications (6). Thus, every effort for preventing unnecessary bleeding is important not only for performing the operation precisely but also for avoiding adverse events following surgery.
In the present study, although various complications were observed, no fatal complications were reported. The rates of complications that occurred within 30 days following RRP ranged from 6.9% to 43% (5,6,12,13). Thromboembolic complications, including pulmonary embolism (0.4% to 2.6%) and cardiac infarction (0.5% to 5%) have been predominant (5,6,11,13). In the present series, only three (2.4%) patients had thromboembolic complications, including one with pulmonary embolism and two with angina. To prevent thromboembolic complications, elevation of the lower extremities and protection of the brachial plexus was recommended (14). At present, we also use an instrument to regularly pump the lower extremities to prevent this complication. Moreover, pelvic lymphoceles and hematomas are reported as important cofactors in the pathophysiology of thromboembolic complications following RRP (15). Lymphatic leakage persisting for more than 2 weeks and lymphocele were reported in 17% and 7% patients, respectively (5), which are much higher than those of the present series (4.9% and 0.8%). In certain situations, the usage of heparin is recommended as prophylaxis for pulmonary embolism.
Late urinary complications such as anastomotic stricture and stress urinary incontinence considerably affect patients’ quality of life. The rates of anastomotic strictures were reported to range from 0.48% to 32% (3,5,12,16–19). In the present series, the incidence was 13.8%. Predictive factors for this complication included current cigarette smoking, history of prostate surgery (including TURP), postoperative anastomotic extravasation, asymptomatic bacteriuria and blood loss (16–18). There was no predictive factor for this complication. However, a past history of TURP was reported to be a risk factor for anastomotic stricture (17). Although it was not significant, it seemed related to this complication. In the present study, at the bladder neck reconstruction after the removal of the prostate, sometimes it was found that the patients with previous TURP had extensive fibrosis at the bladder neck, which might potentially result in the development of an anastomotic stricture. In such a situation, wide resection of the neck is mandatory for avoiding this complication. Sufficient time should be given after TURP for the bladder neck to recover vascularity and epithelial covering. In addition, persistent contact of the drainage tube with the anastomosis site may lead to irritation and extravasation. Care should be taken to place the drains at a sufficient distance from the anastomosis. Moreover, it was reported that postoperative stricture was related to urinary incontinence following relief of obstruction. The rates of urinary incontinence were 46.5% in the stricture group and 12.5% in the control group (19). In the present study, two of the 16 patients with anastomotic strictures developed incontinence following relief of obstruction.
In our opinion, a urodynamic study before and after RRP need not be a routine evaluation. However, for some selected patients, such as those with diabetes, it might be considered necessary to evaluate them carefully preoperatively so as to estimate the postoperative voiding condition. Similarly, a postoperative urodynamic study should be considered in selected patients with complaints of poor stream or urinary tract infection.
Another late urinary complication is postoperative stress urinary incontinence. The rate of urinary incontinence that persisted over 12 months was reported to range from 5.0% to 19.9% (3–5,12). In our series, the rate for the patients who had urinary incontinence persisting for over 12 months was 11.8%. Predictive factors of early continence recovery following RRP were reported to be younger age (4,12,20), and preservation of the puboprostatic ligament (20,21) and neurovascular bundle (21). The relationship between preservation of the neurovascular bundle and recovery of continence is still controversial because there is an opinion that candidates for nerve-sparing surgery tend to achieve continence due to the nature of their overall health, age and stage of the disease (22). The predictive factors of its early recovery in our series were blood loss and surgical period. A large amount of bleeding might have resulted in lack of anatomical identification and inappropriate damage. Our recent series showed a significantly high rate of recovery of continence. This result suggests that improvement of overall skill in management based on adequate surgical experience is necessary to reduce the risk of postoperative urinary incontinence.
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CONCLUSION |
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TOPABSTRACTINTRODUCTIONSUBJECTS AND METHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Radical retropubic prostatectomy was safely performed, though there were various complications that were properly managed intra- or postoperatively. Early recovery of continence was related to the volume of blood loss and surgery period. These results suggest that surgical technique based on extensive experience over a large number of operations contributes to early continence recovery.
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FOOTNOTES |
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+ For reprints and all correspondence: Taiji Tsukamoto, Department of Urology, Sapporo Medical University School of Medicine, S1-W16, Chuo-ku, Sapporo 060-8543, Japan. E-mail: taijit{at}sapmed.ac.jp
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Received December 24, 2003; accepted March 7, 2004
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