Laparoscopic Versus Open Radical Prostatectomy: A Comparative Study at a Single Institution

0022-5347/03/1695-1689/0 THE JOURNAL OF UROLOGY® Copyright © 2003 by AMERICAN UROLOGICAL ASSOCIATION

Vol. 169, 1689 –1693, May 2003 Printed in U.S.A.

DOI: 10.1097/01.ju.0000062614.56629.41

LAPAROSCOPIC VERSUS OPEN RADICAL PROSTATECTOMY: A COMPARATIVE STUDY AT A SINGLE INSTITUTION JENS RASSWEILER, OTHMAR SEEMANN, MICHAEL SCHULZE, DOGU TEBER, MARTIN HATZINGER AND THOMAS FREDE From the Department of Urology, Klinikum Heilbronn, University of Heidelberg, Germany

ABSTRACT

Purpose: There is an ongoing debate about the benefits of laparoscopic radical prostatectomy compared to the open retropubic approach. We compared the last 219 patients treated with open retropubic prostatectomy with 438 patients treated with laparoscopic radical prostatectomy at our institution, focusing on operative data, complications and mid-term outcome. Materials and Methods: From December 1994 to November 1999 a total of 219 patients were treated with open prostatectomy and pelvic lymph node dissection (group 1). From March 1999 to September 2002, 219 patients underwent early (group 2) and 219 underwent late (group 3) laparoscopic radical prostatectomy and pelvic lymph node dissection. The same surgeons performed both operations. All 3 groups were similar with respect to mean patient age, mean prostate specific antigen value, median Gleason score, previous transurethral resection of the prostate and neoadjuvant treatment, although there was a slight stage shift in favor of the 2 laparoscopic groups. Results: Mean operating time was significantly shorter after open surgery (196 minutes) compared to the early laparoscopic group (288) but it did not differ significantly from the late laparoscopic group (218). Mean blood loss (1,550 versus 1,100 versus 800 cc) and transfusion rates (55.7% versus 30.1% versus 9.6%) in groups 1 to 3 favored the laparoscopic groups. The complication rate in groups 1 to 3 was lower for laparoscopy (19.2% versus 13.7% versus 6.4%), but the spectrum differed. The early laparoscopic group had a higher incidence of rectal injuries (1.8% versus 3.2% versus 1.4% in groups 1 to 3, respectively) and urinary leakage (0.5% versus 2.3% versus 0.9%), whereas more lymphoceles (6.9% versus 0% versus 0%), wound infection (2.3% versus 0.5% versus 0%), embolism/pneumonia (2.3% versus 0.5% versus 0.5%) and anastomotic strictures (15.9% versus 6.4% versus 4.1%) occurred after open surgery. The amount of postoperative analgesia was significantly greater after open surgery (50.8 versus 33.8 versus 30.1 mg. in groups 1 to 3, respectively). Median catheter time was longer after open retropubic prostatectomy (12 versus 7 versus 7 days in groups 1 to 3, respectively) but the continence rates were similar in all 3 groups at 12 months (89.9% versus 90.3% versus 91.7%). The rate of positive margins did not differ significantly in groups 1 to 3 (28.2% versus 21.0% versus 23.2%), prostate specific antigen recurrence was equivalent related to the different observation periods. Conclusions: Laparoscopic radical prostatectomy is technically demanding, with an initially longer operative time, higher incidence of rectal injuries and urinary leakage. The overall outcome after 219 cases favors the laparoscopic approach. Consequently, at our institution laparoscopic radical prostatectomy has become the method of choice. KEY WORDS: laparoscopy, prostatic neoplasms, prostatectomy

Laparoscopic radical prostatectomy has gained interest worldwide based on the initial report of Guillonneau and Vallancien.1 However, there is an ongoing debate about the benefits of this procedure compared to its open counterpart.2 Recently, we presented our initial experience with a laparoscopic technique similar to the classic retropubic radical prostatectomy.3 We compare the results of patients treated with open surgery during a 5-year period at our institution with those of patients treated with the laparoscopic approach during the last 3 years, focusing on operative data, complications and outcome. MATERIALS AND METHODS

Patients. From December 1994 to November 1999 a total of 219 patients were treated with open retropubic prostatec-

tomy and pelvic lymph node dissection (group 1) (table 1). From March 1999 to September 2002 a total of 521 patients underwent laparoscopic radical prostatectomy at our institution. The 438 cases in which pelvic lymph node dissection was part of the procedure were divided into 2 equal groups of early (group 2) versus late (group 3) prostatectomy. The same surgeons (J. R., O. S., M. H.) performed both operations. All 3 groups were similar with respect to mean patient age, median Gleason score, previous transurethral prostate resection and neo-adjuvant treatment, although there was a slight stage shift (pT stage, prostate specific antigen [PSA]) in favor of the 2 laparoscopic groups. Only the percentage of pT2b (18.3% versus 33.3% versus 47.0%) and pT4 (10.9% versus 4.6% versus 2.3%) stages proved to be statistically significant in groups 1 to 3, respectively. Procedures. The open retropubic radical prostatectomy was performed according to the technique described by Walsh.4 The Heilbronn technique was used for laparoscopic radical

Accepted for publication November 22, 2002. Presented at annual meeting of American Urological Association, Orlando, Florida, May 25–30, 2002. 1689

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LAPAROSCOPIC VERSUS OPEN RADICAL PROSTATECTOMY TABLE 1. Patient data

No. pts. Recruitment time Pt. age (range) No. pathological stage (%): pT1 pT2a pT2b pT3a pT3b pT4 Median Gleason score (range) Av. PSA (ng./ml.) Av. prostate volume (cc) Av. specimen wt. (gm.) No. transurethral prostate resection (%) No. neoadjuvant therapy (%) No. previous surgery (%) * Statistically significant difference (p ⬍ 0.05).

Group 1

Group 2

Group 3

219 12/1994-11/1999 65 (50–79)

219 3/1999-9/2001 64 (43–76)

219 9/2001-9/2002 64 (44–81)

5 (2.3) 55 (25.1) 40 (18.3) 72 (32.9) 21 (9.6) 24 (10.9) 7 (5–9) 11.9 (1.8–82.2) 38.0 (5–124) 40.7 (6–122) 13 (5.9) 63 (28.7) 11 (5.1)

5 (2.3) 43 (19.9) 73 (33.3) 53 (24.2) 35 (16.2) 10 (4.6) 6 (3–9) 14.6 (0.6–148) 30.3 (3–70) 40.7 (10–90) 11 (5.0) 55 (23.1) 15 (6.8)

1 (0.5) 39 (17.8) 103 (47.0)* 49 (22.4) 22 (10.0) 5 (2.3)* 6 (3–10) 10.6 (0.4–108) 33.2 (12–92) 44.7 (16–106) 3 (2.1) 31 (22.0) 28 (12.8)

prostatectomy as described recently.3 Following transperitoneal access to Retzius space, radical prostatectomy is performed with early control of the dorsal vein complex and transection of the urethra. In both groups nerve sparing techniques were applied when indicated. Operative time was defined from the first incision (lower abdomen or periumbilically) to complete closure of the wound or trocar incisions. Postoperative care and patient evaluation. All patients received 3 ⫻ 5,000 units heparin daily on postoperative days 1 and 2 followed by a single dose of low molecular heparin. If possible, all patients were mobilized on postoperative day 1. A cystourethrogram was performed 10 to 14 days after open surgery and 5 to 7 days after laparoscopy. In case of urinary leakage the catheter was kept in place for another 7 days before checking the anastomosis radiographically. Statistical analysis. For comparison of the results, a separate analysis of 3 groups was performed (tables 1 to 4). The differences between group 1, and groups 2 and 3 were analyzed using the chi-square test, with p ⬍0.05 considered statistically significant. RESULTS

Operative data and morbidity. Mean operating time for open surgery was significantly shorter than that in early laparoscopic group (table 2). Compared to the late laparoscopic group, however, this shorter time was only a minor advantage, which did not reach statistical significance (196 versus 288 versus 218 minutes in groups 1 to 3, respectively).

The percentage of nervesparing procedure did not differ between open and early laparoscopic radical prostatectomy but more patients underwent nerve sparing in the late laparoscopic series (12.3% versus 16.9% versus 33.8%). Median estimated blood loss was similar in the open and early laparoscopic groups but significantly lower in the late laparoscopic group (1,550 versus 1,100 versus 800 cc). Thus, the transfusion rate (autologous and allogenic) was greater in the open and significantly reduced in the early and late laparoscopic groups (55.7% versus 30.1% versus 9.6%). There were 9 conversions to open surgery following laparoscopy. In the early group the conversion rate was 3.7% (8 patients) and only a single conversion (0.5%) was necessary in the late laparoscopic group. The early re-intervention rate in the open group did not differ compared to the early laparoscopic group, but was significantly lower in the late laparoscopic group (6.8% versus 4.1% versus 1.8%). Moreover, the spectrum of intervention was different after open and laparoscopic surgery. After open retropubic prostatectomy re-intervention was required mainly for postoperative bleeding (4.6% versus 0.9% versus 0.9% in groups 1 to 3, respectively) and drainage of lymphoceles (1.8% versus 0% versus 0%). Following laparoscopy temporary urinary diversion with a Double-J (Medical Engineering Corp., New York, New York) stent and percutaneous nephrostomy (0.5% versus 3.2% versus 0.9% for groups 1 to 3, respectively) because of urinary extravasation were the main indications for reintervention.

TABLE 2. Operative data and postoperative course Group 1 Mean operating mins. (range) % Nerve sparing prostatectomy No. unilat. No. bilat. Median cc blood loss (range) % Transfusion rate No. allogenic transfusion (%) Av. units blood cells % Conversion to surgery No. early re-intervention (%): Laparotomy (bleeding) Laparoscopy (bleeding) Percutaneous nephrostomy (urinoma) Double-J-stent (urinoma) Colostomy (fistula) Percutaneous drainage of lymphocele % Prolonged catheter Median catheter days (range) Av. postop. analgesics (mg.) % Analgesics day 2 Median hospital days (range) No. days back to normal activity (range) * Statistically significant difference (p ⬍0.05).

196 (90–320) 12.3 17 10 1,550 (200–8,000) 55.7 59 (26.9) 3.2 Not available 15 (6.8) 10 — 1 — — 4 15.1 12 (7–75) 50.8 55 16 (9–45) 52 (21–75)

Group 2 288 (154–500)* 16.9 32 5 1,100 (200–3,500) 30.1* 31 (14.2)* 2.3 3.7 9 (4.1) 2 — 5 — 2 — 12.8 7 (5–60)* 33.8* 9 12 (5–41) 31 (14–55)*

Group 3 218 (113–320) 33.8* 35 39 800* (300–4,000) 9.6* 12 (5.5)* 2.1 0.5 4 (1.8) 1 1 — 2 — — 13.2 7 (4–52)* 30.1* 9 11 (6–27)* 27 (12–50)*

LAPAROSCOPIC VERSUS OPEN RADICAL PROSTATECTOMY TABLE 3. Complications and late re-interventions Group 1 No. early complications: Pelvic hematoma Prolonged ileus Urinoma Rectal injury Rectal fistula Lymphocele Embolism/pneumonia Sepsis Wound infection Neurological problems Myocardial infarction No. late complications/total No. (%): Anastomotic stricture Hernia Incontinence at 12 mos. Persistent incontinence No. late re-intervention (%) * Statistically significant difference

5 1 1 3 1 15 5 1 5 3

Group 2 7 5 5 3 4

Group 3

—

—

3 3 2 — 3 — 1 — — 1 1

35 (15.9) 3 22 (10.1) 15 (6.8) 38 (17.4) (p ⬍ 0.05).

14 (6.4)* 2 21 (9.7) 9 (4.2) 17 (7.8)*

9 (4.1)* — 5/60 (8.3) Not available 9 (4.1)*

— 1 — 1 1

The overall amount of postoperative analgesia (that is piritramide) was significantly higher after open surgery compared to early and late laparoscopic (50.8 versus 33.8 versus 30.1 mg.). Although the required pain medication was similar during the first night, it differed significantly postoperative day 1 in groups 1 to 3 (24.2 versus 5.4 versus 5.1 mg.), mainly because after open surgery most of the patients still required analgesics (83% versus 33% versus 31%). On postoperative day 2 analgesics were administered to 55% of the patients after open and 9% after laparoscopic surgery. Median catheter time was significantly longer after open (12 versus 7 versus 7 days) compared to early and late laparoscopic radical prostatectomy but the rate of prolonged catheterization did not differ in groups 1 to 3 (15.1% versus 12.8% versus 13.2%). Thus, median hospital stay was significantly longer after open surgery compared to both laparoscopic groups (16 versus 12 versus 11 days). The 4 to 5-day interval between catheter removal and discharge from the hospital can be explained by the health system in Germany. All of our patients receive pelvic floor exercise and biofeedback training of the external urethral sphincter with transrectal ultrasound in the early phase after catheter removal. This strategy was the same for all 3 groups. Finally, convalescence time was significantly longer after open than early or late laparoscopic surgery (52 versus 31 versus 27 days). Complications. The early complication rate was similar when comparing the open with the early laparoscopic groups but significantly lower in the late laparoscopic group (19.2% versus 13.7% versus 6.4%, table 3). However, the spectrum of the complications differed. In the early laparoscopic group there were more rectal injuries (3.2% versus 1.8% versus 1.8%) and urinary leakage (2.3% versus 0.5% versus 0.9%) compared to the open group. On the other hand, the incidence of lymphoceles (6.9% versus 0% versus 0%), wound infection (2.3% versus 0.5% versus 0%) and embolism/pneumonia (2.3% versus 0.5% versus 0.5%) was higher after open surgery than after early or late TABLE 4. Oncological data Group 1

Group 2

Median mos. followup (range) 67 (97-43) 30 (45-13) No. pT1/2 (%) 100 (45.7) 121 (55.3) No. pos. margins (%): 63 (28.7) 46 (21.0) pT2a 1 (1.8) 1 (2.3) pT2b 5 (15.2) 7 (9.6) pT3a 22 (30.6) 9 (17.3) pT3b 11 (52.4) 19 (54.3) pT4 24 (100) 10 (100) No. PSA relapse/total No. (%) 31/178 (17.4) 29 (13.2) No. survival rate/total No. (%): Overall 171/177 (96.6) 216 (98.6) Disease specific 172/177 (97.2) 217 (99.1) None of the differences reached statistical significance.

Group 3 8 (13-1) 143 (65.3) 52 (23.7) 1 (2.5) 16 (15.5) 19 (38.8) 12 (54.5) 5 (100) Not available Not available Not available

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laparoscopy. One patient (0.5%) died after open radical prostatectomy of a fulminant pulmonary embolism. One patient (0.5%) in the late laparoscopic group required postoperative defibrillation and recanalization of 2 occluded coronary artery stents. There was no mortality after laparoscopic surgery. All intraoperative rectal injuries were managed by either open or endoscopic suturing with an uneventful postoperative course but a prolonged catheter time of up to 14 days. In 8 patients a recto-urethral fistula developed 7 to 10 days after surgery, which healed spontaneously with prolonged catheterization and intravenous alimentation in 6 (open group 1, early laparoscopy 2 and late laparoscopy 3). A temporary colostomy was required in 2 patients after laparoscopy. The rate of anastomotic strictures was significantly higher in the open group compared to the early and late laparoscopic groups (15.9% versus 6.4% versus 4.1%). All strictures could be managed successfully by endoscopic laser incision. The continence rates in groups 1 to 3 were similar at 12 (89.9% versus 90.3% versus 91.7%) and at 18 in groups 1 and 2 (93.2% versus 95.8%) months. Oncological results. The overall rate of positive margins did not differ significantly in the 3 groups (table 4). According to stage shifting to organ confined tumors (pT1/2) in the laparoscopic groups, the rate of positive surgical margins was slightly higher after open surgery than after early and late laparoscopy (28.7% versus 21.0% versus 23.7%). PSA relapse, defined as an increase of serum levels greater than 0.2 ng./ ml., was observed in 31 of 178 patients (17.4%) after open and 29 of 219 patients (13.2%) after early laparoscopic radical prostatectomy. The overall and disease specific survival did not differ in these 2 groups in relation to the different observation times (67 versus 30 months). DISCUSSION

Radical retropubic prostatectomy is considered one of the most effective options for localized prostatic cancer. Despite technical improvement,4 – 6 the procedure is still associated with significant morbidity including bleeding, postoperative pain, thromboembolism, incontinence, impotence and strictures at the urethrovesical anastomosis (tables 5 and 6).6 –14 Laparoscopic radical prostatectomy has been introduced to combine the advantages of open prostatectomy with those of minimally invasive surgery in an attempt to reduce intraoperative and postoperative morbidity.1–3, 15–20 Until now, widespread application was mainly limited due to the technical difficulty of the procedure, resulting in a higher rather than lower associated morbidity in the hands of beginners.2 Moreover, advocates of open surgery are still not convinced of the benefits of laparoscopic radical prostatectomy even in the hands of experts.4 – 6 Our results of open radical prostatectomy are based on previous experience with about 150 cases performed by one of us (J. R.), who trained 2 of us (O. S., M. H.). Laparoscopic radical prostatectomy was introduced based on this surgical experience plus the expertise of more than 750 laparoscopic or retroperitoneoscopic procedures after the same training as previously mentioned. This scenario is comparable to other previously published reports mainly from academic centers8 – 11, 13 or multi-institutional series.14 However, it differs from recent publications from highly specialized centers at which a single surgeon exclusively performs all cases.4 –7, 12 Our results of open surgery do not differ from various recently published studies with respect to operative time, allogenic transfusion, re-intervention and complication rate (table 5). The same applies to laparoscopic series when compared to the results of other centers. Initially, the laparoscopic approach was characterized by a longer operating time, slightly higher incidence of rectal lesions and urine extravasation. On the other hand, other complications such as lymphoceles, pulmonary embolism, wound infection and

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LAPAROSCOPIC VERSUS OPEN RADICAL PROSTATECTOMY TABLE 5. Postoperative course References

Open radical prostatectomy: Hautmann et al8 Hammerer et al9 Davidson et al10 Dillioglugil et al7 Gaylis et al11 Gheiler et al13 Catalona et al12 Arai et al14 Guillonneau and Vallancien1 Lepor et al6 Present series Laparoscopic radical prostatectomy: Guillonneau and Vallancien1 Abbou et al15 Rassweiler et al3 Guillonneau et al19 Turk et al17 Hoznek et al16 Bollens et al18 Present study: Early Late

No. Pts.

Operating-time (mins.)

% Early Re-intervention

% Early Complications

% Transfusion Allogenic Rate

418 320 188 472 116 1,129 1,870 638 100 1,000 219

168 Not available Not available 182 155 Not available Not available 263 135 Not available 196

9.0 7.3 15.0 1.6 1.8 4.0 Not available 2.0 Not available 1.0 6.8

23.0 21.9 43.0 14.2 5.4 7.9 4.2 20.2 Not available 3.3 19.2

Not available 27.8 Not available 9.3 Not available Not available 9.0 19.1 31.0 9.7 26.9

120 43 180 350 125 217 50

239 320 271 217 235 281 317

2.5 11.6 4.5 4.0 2.1 Not available 4.0

5.9 16.2 15.0 16.7 10.5 Not available 18.0

10.0 Not available 17.0 5.7 3.0 2.0 13.0

219 219

288 218

4.2 2.0

13.9 6.1

14.2 5.5

TABLE 6. Followup results References Open radical prostatectomy: Hautmann et al8 Hammerer et al9 Davidson et al10 Gaylis et al11 Catalona et al12 Lepor et al6 Present study Laparoscopic radical prostatectomy: Guillonneau and Vallancien1 Abbou et al15 Rassweiler et al3 Guillonneau et al19 Turk et al17 Hoznek et al16 Bollens et al18 Present study: Early Late

No. Pts.

Pos. Margins (all/pT2)

PSA Relapse (greater than 0.2 ng./ml.)

Continence 12 Mos.

Anastomotic Stricture

418 320 188 116 1,870 1,000 219

Not available Not available Not available 37.0/17.2 Not available 20.0 28.7/15.7

Not available 16.6 Not available Not available 7.0 1.0 15.1

81.0 91.0 86.0 92.0 92.0 Not available 89.9

8.9 7.6 32.0 Not available 3.8 1.0 15.9

120 43 180 350 125 217 50

19.0/17.6 27.7/18.4 16.0/2.3 15.1/10.7 44.1/29.4 24.6/16.8 22/8.0

5.3 Not available 5.0 8.0 2.1 10.0 4.0

88.3 84.0 97.0 85.5 92.0 86.2 85.0

0.0 0.0 3.3 0.0 1.4 Not available 0.0

219 219

21.0/6.8 23.7/11.9

13.4 Not available

90.3 91.7

6.4 4.1

anastomotic strictures occurred less frequently. Additionally, catheterization time was significantly shorter. However, the operating time of our last 219 laparoscopic cases was only slightly longer than that of open surgery and all of the other aforementioned advantages are evident (tables 2 and 3). Investment of the initially higher operating time resulted in an evolution of the approach with significant benefit for our patients. The reduction of operating time decreased the associated morbidity of the procedure. The video assistance with 5-fold magnification enabled us to improve the dissecting techniques of open surgery (that is at the apex, neurovascular bundles, bladder neck and cranial pedicles). The endoscopic suturing technique with completion of the anastomosis under endoscopic vision improved the quality of the anastomosis (that is shorter catheter time, lower stricture rate). Additionally, the postoperative pain and hospital stay was reduced together with a significantly shorter convalescence time. We strongly believe that our progress is mainly related to the advantages of the laparoscopic access. However, one may argue that the increased frequency from less than 50 cases of open to more than 200 cases of laparoscopic radical prostatectomy per year has significantly contributed to our success. Nevertheless, the learning curve of the procedure has not yet plateaued, which is similar to open surgery.4 –7 Dillioglugil et al reported a mean operating time of 182 minutes for open radical

prostatectomy after decreasing from 217 minutes in 1990 to 170 minutes in 1994.7 While performing 472 cases they reduced the operating time in 4 years by 47 minutes (21.7%). In our 438 laparoscopic cases we reduced the operating time by 107 minutes from 325 minutes in 1999 to 218 minutes in 2002 (32.9%). This rate is similar to that of others (table 5). Therefore, further reduction in operating time can be anticipated in all laparoscopic series from experienced centers. However, as with open surgery, there remains a potential for technical improvement in laparoscopic radical prostatectomy. Shorter catheter times (that is less than 4 days) did not prove to be effective because of a higher incidence of hypercontinence and secondary urinoma.19 However, in cases of an optimal anastomosis (tight, no tension, no extravasation) the risk of a postoperative stricture is negligible (table 6). Whereas following open surgery the patient is usually sent home with the indwelling catheter being removed on day 21, the laparoscopic suturing technique enables catheter removal 5 to 7 days following the procedure. Because of the early convalescence after laparoscopy expectation regarding early removal of the catheter is high. Therefore, we need to decrease the rate of prolonged extravasation, that is by further improvement of the dissection at the apex and bladder neck with minimal use of bipolar or monopolar coagulation. The oncological quality of laparoscopic prostatectomy should be at least similar to that of open surgery. In our

LAPAROSCOPIC VERSUS OPEN RADICAL PROSTATECTOMY

series the rate of positive margins was slightly higher after open surgery but not statistically significant. Moreover, if related to pathological stage, there was no difference among all 3 groups (table 4). Our results are similar to those of other laparoscopic and open series. PSA relapse, defined as an increase in serum levels greater than 0.2 ng./ml., was observed in 17.4% of our patients 67 months after open surgery versus 13.4% 30 months following laparoscopy. Overall and disease specific survival did not differ as well. Again, these results are similar to those of other open and laparoscopic series (table 6). It must be mentioned that none of the laparoscopic centers observed any port site metastasis or increased risk of local recurrence.15–19 Therefore, the oncological results documented so far after laparoscopic radical prostatectomy are comparable to those obtained by open surgery. However, longer followup is still necessary to draw final conclusions. Laparoscopic radical prostatectomy provides an excellent basis to transfer all technical modifications of anatomical radical prostatectomy as described by Walsh4 or Steiner.5 With increasing experience, all technical developments by our outstanding open surgical pioneers can be transferred to laparoscopy. Additionally, however, laparoscopic surgery provides better access to the anastomosis as suturing is performed under endoscopic vision. Based on our personal experience with the use of robot assisted or telesurgical laparoscopic radical prostatectomy, we do not see a lot of additional advantages of this technology for experienced laparoscopic surgeons. However, there is the impression that telesurgical systems like the da Vinci may significantly flatten the learning curve for nonlaparoscopists.20 Dr. Adrian Joyce revised the article.

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REFERENCES

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