Morbidity of laparoscopic radical prostatectomy: Summary of early multi-institutional experience in Japan
Yoichi Arai md, Department of Urology, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan.
Aim: Laparoscopic radical prostatectomy is being evaluated throughout the world. The aim of the present study is to report early multi-institutional experience of the procedure in Japan.
Methods: A total of 148 men who were diagnosed with clinically localized prostate cancer underwent laparoscopic radical prostatectomy at seven different institutions in Japan. Early complications (within 30 days postoperatively) and postoperative convalescence were reviewed retrospectively. The median age of patients was 68.0 years (range, 51–80).
Results: The median operative time was 403 minutes (range, 167–925; average, 427). Blood loss ranged from 50 to 5000 mL (median, 540; average, 856). A total of 66 complications were reported in 55 patients (37.2%). Intraoperative complications were noted in 25 of 148 patients (16.9%): 10 rectal injuries (6.8%); five bladder injuries (3.4%); five cases of subcutaneous emphysema (3.4%); two intestinal injuries (1.4%); one major vessel injury (0.7%); one ureteral injury (0.7%); and one obturator nerve injury (0.7%). Overall, 16 of 148 patients (10.8%) required open conversion or postoperative open surgical repair. The most common postoperative complications were anastomotic leakage (6.8%), wound-related complications (4.7%) and perineal pain (4.7%). The bladder catheter was removed on day 7 or earlier in 73 cases (49.3%). The median time to ambulation was 1 day (mean 1.4, range 1–5). Oral intake was started on postoperative day 1 in 67 patients (45.2%) and on postoperative day 2 in 65 (43.9%).
Conclusion: Although laparoscopic radical prostatectomy is technically demanding, reduced blood loss and shorter convalescence periods can be expected from the procedure. Surgeons should be aware of the disturbingly high morbidity rate related to early experience. By mastering laparoscopic skills and sharing knowledge, surgeons could reduce the impact of the learning curve required to complete this procedure competently.
From the time that the French groups introduced laparoscopic radical prostatectomy, the procedure has been evaluated worldwide.1–9 With increasing experience and technical improvement, they have been successful in decreasing the incidence of morbidity associated with the procedure.4,6,8,9 However, before accepting this procedure as a part of our standard care, particularly in comparison with retropubic or perineal radical prostatectomy, many questions need to be answered in terms of morbidity, functional results, oncological outcome and cost. The aim of the present study is to report early multi-institutional experience in Japan, focusing mainly on morbidity and postoperative related to the procedure. The detailed early oncological outcome has been reported elsewhere.10
Between December 1999 and September 2001, 148 men diagnosed with clinically localized prostate cancer (T1–T3N0M0) underwent laparoscopic radical prostatectomy at seven different institutions in Japan. The median age of patients was 68.0 years (range, 51–80). Written informed consent was obtained from all patients. According to the 1997 TNM classification,11 the 148 patients were classified as follows: stage T1 (82 patients); T2 (59 patients); and T3 (7 patients). Twenty-five patients underwent neoadjuvant endocrine therapy, with or without chemotherapy (antiandrogen therapy alone; or luteinizing hormone-releasing hormone agonist, with or without futraful) for a median period of 3 months (range, 0.5–10 months). Median preoperative serum prostate-specific antigen (PSA) was 7.7 ng/mL (range, 1–269 ng/mL). PSA was measured at different laboratories using various techniques. These included Tandem R PSA assay (YAMASA, Chiba, Japan); ECLIA assay (Nippon Roche KK, Tokyo, Japan); DPC Immulize PSA assay (Dia-Iatron, Tokyo, Japan); Architect PSA assay (Dinabot, Tokyo, Japan); AxSYM PSA assay (Dinabot, Tokyo, Japan); and Lumipulse PSA assay (Fujirebio, Tokyo, Japan). Results of these assays were not inter-converted, because they are considered virtually identical.12
Several different surgeons conducted laparoscopic radical prostatectomy at each institution according to the original method of the Montsouris4 and Heilbronn group,13 or with some modifications.14 Transperitoneal approach was performed in 96 patients, extraperitoneal approach in 21, and the remaining 21 procedures were completed with combined approaches as reported elsewhere.14 Eighty-five patients underwent simultaneous laparoscopic pelvic lymph node dissection at the discretion of each surgeon. A nerve-sparing procedure was performed in 33 patients (22.3%). Bilateral techniques were performed in eight and unilateral nerve-sparing in 25. Low-dose heparin was used as a prophylactic measure for thromboembolic complications in 30 patients.
An electronic database was created, and the data were abstracted directly from the records. Data abstracted and entered were specifics of surgery, such as duration, blood loss, transfusion, nerve-sparing methods, early complications, open conversion and postoperative convalescence (duration of bladder catheterization, time to first oral intake and time to ambulance). Early complications were defined as those that occurred within 30 days postoperatively. Mann–Whitney U- and Kruskal–Wallis tests were used to compare variables, and χ2 statistics were used to compare categorical variables, with P ≤ 0.05 as significant.
Duration of surgery, blood loss and transfusion
The median operative time was 403 minutes (range, 167–925; average, 427). Blood loss ranged from 50 to 5000 mL (median, 540; average, 856). Of 148 patients, 103 (69.6%) had blood loss of 1000 mL or less. Only nine patients (6%) received allogeneic transfusion. None of the 51 patients who donated preoperative autologous blood received subsequent allogeneic transfusion. There was no difference in operative time or blood loss between patients with and without neoadjuvant hormonal therapy (data not shown).
Intraoperative complications and open conversion
A total of 66 complications was reported in 55 patients (37.2%) (Table 1). Intraoperative complications were noted in 25 of 148 patients (16.9%): 10 rectal injuries (6.8%); five bladder injuries (3.4%); five cases of subcutaneous emphysema (3.4%); two intestinal injuries (1.4%); one major vessel injury (0.7%); one ureteral injury (0.7%); and one obturator nerve injury (0.7%). Three of the 10 rectal injuries were repaired laparoscopically. Four required open conversion, two of which involved the creation of a temporary colostomy. In the remaining three patients, rectal injury was not identified during surgery, but was diagnosed postoperatively in the context of the postoperative peritonitis or ileus. These patients required temporary intestinal diversion by colostomy. Although there was no significant difference, patients who were treated with neoadjuvant hormone therapy experienced a higher incidence of rectal injury (12%) than those who did not receive such treatment (5.7%). Two ileocolonic injuries required open conversion. Other open conversions were conducted as a result of massive bleeding in two patients, long duration of surgery in two, technical difficulty of urethroanastomosis in two, and obesity in one. Thus, overall, 16 of 148 patients (10.8%) required open conversion or postoperative open surgical repair.
Table 1. Morbidity of 148 patients who underwent laparoscopic radical prostatectomy for clinically localized prostate cancer
| Rectal injury||10 (6.8)|
| Bladder injury|| 5 (3.4)|
| Subcutaneous emphysema|| 5 (3.4)|
| Intestinal injury|| 2 (1.4)|
| Major vessel injury|| 1 (0.7)|
| Obturator nerve injury|| 1 (0.7)|
| Ureteral injury|| 1 (0.7)|
| Anastomotic leakage||10 (6.8)|
| Wound infection/dehiscence|| 7 (4.7)|
| Perineal pain|| 7 (4.7)|
| Ileus|| 3 (2)|
| Peritonitis|| 2 (1.4)|
| Lymphocele|| 2 (1.4)|
| Port site herniation|| 2 (1.4)|
| Vesicorectal fistula|| 2 (1.4)|
| Catheter malfunction|| 1 (0.7)|
| Hydronephrosis|| 1 (0.7)|
| Pelvic hematoma|| 1 (0.7)|
| Acute cholecystitis|| 1 (0.7)|
| Peripheral nerve palsy|| 1 (0.7)|
| Hoarseness|| 1 (0.7)|
| Death within 30 days|| 0 (0)|
Postoperative early complications
Distribution of the types of early complications is shown in Table 1. The most common complications were anastomotic leakage (6.8%), wound-related complications (4.7%) and perineal pain (4.7%). All but one wound-related complication were easily managed in a conservative method. There were two cases of lymphocele that were managed conservatively. One involved the tube malfunction of a retained catheter. Two patients developed vesicorectal fistula that required colostomy. One patient had postoperative unilateral hydronephrosis that resolved spontaneously. One patient had formation of pelvic hematoma that did not require drainage.
Gastrointestinal complications consisted of three intestinal obstructions, one case of peritonitis, and one of acute inflammation of the gall bladder. The peritonitis was caused by intraoperative rectal injury, which was later diagnosed and required colostomy. Two patients had port site herniation. One had peripheral nerve palsy due to the long duration of surgery. There were no thromboembolic complications such as pulmonary embolism or deep venous thrombosis. There were no cases of myocardial infarction. No patients died perioperatively.
The median duration of bladder catheterization was 7 days (mean, 14.4; range 3–196). The bladder catheter was removed on day 7 or earlier in 73 cases (49.3%). The median time to ambulation was 1 day (mean, 1.4; range, 1–5). One hundred and five patients (70.9%) were able to walk on postoperative day 1. The median duration to first oral intake was 2 days (mean, 2.6; range, 1–120). Oral intake was started on postoperative day 1 in 67 patients (45.2%) and on day 2 in 65 (43.9%). Oral intake was delayed in the remaining patients due to bowel complications (Table 2).
Table 2. Postoperative convalescence of 148 patients who underwent laparoscopic radical prostatectomy for clinically localized prostate cancer
| 3|| 4 (2.7)|
| 4|| 7 (4.7)|
| 5|| 27 (18.2)|
| 6|| 16 (10.8)|
| 7|| 19 (12.8)|
| 8|| 12 (8.1)|
| 9|| 5 (3.4)|
| 10|| 2 (1.4)|
| > 10|| 56 (37.8)|
|Days to ambulance|
| 1||106 (71.6)|
| 2|| 30 (20.3)|
| 3|| 7 (4.7)|
| 4|| 4 (2.7)|
| 5|| 1 (0.7)|
|Days to first oral intake|
| 1|| 67 (45.3)|
| 2|| 65 (43.9)|
| 3|| 6 (4.1)|
| 4|| 3 (2.0)|
| 5|| 2 (1.4)|
| > 5|| 4 (2.7)|
French investigators have improved the technical aspects of laparoscopic radical prostatectomy and claim that the procedure is a standardized therapeutic option for clinically localized prostate cancer.3,4,6–8 The potential advantages of this procedure include improved visualization of the anatomy, reduced blood loss, better preserved anatomical structures, and a shorter convalescence period.
The median blood loss in the present study was 540 mL, which is apparently less than that reported in open radical retropubic prostatectomy in Japan.15 Only six percent of patients required allogeneic transfusion. The French group reported that mean blood loss was 514 mL in the initial 50 cases, which decreased to less than 300 mL with accumulated experience.9 Optical magnification associated with more precise knowledge of the anatomy, and pneumoperitoneum probably explains the decreasing blood loss. This decreased blood loss, compared with that in other open prostatectomy series, might explain the low cardiovascular complication rate in our series with no deaths or myocardial infarctions and no cerebrovascular accidents. On the other hand, the major drawback of this procedure is the long operative time. The mean operative time was 427 min in the present series. Weber et al. reported a duration of 495 min in their initial nine cases, and they prematurely terminated the series because of their unacceptable results.16 The French group reported a mean operative time of 268 min in their initial 50 cases, which was successfully reduced to less than 180 min by their accumulation of experience in over 500 cases.9
The incidence of patients who presented with at least one complication in this multi-institutional study was 37.3%, a figure disturbingly higher than that reported by Guillonneau et al.9 An 8.1% incidence of bowel injuries was noted, including rectal injury in 10 cases (6.8%) and ileocolonic injury in two (1.4%). Three rectal injuries not detected intraoperatively caused serious complications such as peritonitis and ileus. Nine of the 12 bowel injuries (75%) required open conversion or postoperative open surgical repair. It has been reported that rectal injury occurs during section of the recto-apical Denonvilliers’ fascia when posterior dissection has not been performed sufficiently close to the apex.6,9 When such an injury is diagnosed intraoperatively, it can be easily repaired laparoscopically without the need for colostomy. Ureteral injury occurred in one case (0.7%). In this case, the ureter was sectioned after being mistaken for the vas deferens. It is important to identify the vas deferens based on its relationship with the seminal vesicle.3–5 Bladder injury usually occurred when the prevesical space was entered, but it was easily repaired intraoperatively.
Early removal of the bladder catheter is expected in laparoscopic radical prostatectomy, because sufficient watertight vesicourethral anastomosis is possible under the field of optical magnification. Catheter removal is based on a surgeon-subjective analysis of the anastomosis. Guillonneau et al. showed that the catheter could be removed on day 3 if the anastomosis is immediately watertight.9 In the present study, about half of the patients were catheter-free at postoperative day 7 or earlier. However, 25 patients (16.9%) required prolonged catheterization of 14 days or longer, suggesting that laparoscopic vesicourethral anastomotic procedure is still technically difficult. Convalescence seems to be shorter in laparoscopic radical prostatectomy than in open prostatectomy. About 70% of patients were able to walk and began oral intake at postoperative day 1.
With regard to the causes of perioperative death after major urologic pelvic surgery, risk from thromboembolic disease has been reported to be the most serious complication.15 Initially, we were concerned that combining pelvic with laparoscopic surgery may increase the risk of thromboembolic disease. There were no thromboembolic complications such as pulmonary embolism or deep venous thrombosis. Reduced blood loss and shorter convalescence probably explain the extremely low rate of such serious complications.
In summary, we have reported in the present paper the early experience of laparoscopic radical prostatectomy performed at seven different institutions in Japan. Although the procedure is technically demanding, reduced blood loss and a shorter convalescence period can be expected. Surgeons should be aware of the disturbingly high morbidity rate related to early experience. The accumulation of experience and sharing of knowledge can possibly reduce the impact of learning curve required to perform this procedure competently.