EXTRAPERITONEAL LAPAROSCOPIC RADICAL PROSTATECTOMY: A PROSPECTIVE EVALUATION OF 600 CASES

0022-5347/05/1743-0908/0 THE JOURNAL OF UROLOGY® Copyright © 2005 by AMERICAN UROLOGICAL ASSOCIATION

Vol. 174, 908 –911, September 2005 Printed in U.S.A.

DOI: 10.1097/01.ju.0000169260.42845.c9

EXTRAPERITONEAL LAPAROSCOPIC RADICAL PROSTATECTOMY: A PROSPECTIVE EVALUATION OF 600 CASES FRANC ¸ OIS ROZET,* MARC GALIANO, XAVIER CATHELINEAU, ERIC BARRET, NATHALIE CATHALA AND GUY VALLANCIEN From the Department of Urology, Institut Montsouris, Universite´ Pierre et Marie Curie, Paris, France

ABSTRACT

Purpose: We report our experience with the extraperitoneal approach to laparoscopic radical prostatectomy. We describe the technique, clinical and oncological results, and functional outcome. Materials and Methods: From February 2002, to March 2004, 600 laparoscopic radical prostatectomies were performed by an extraperitoneal approach and evaluated prospectively. Results: A total of 599 extraperitoneal procedures were performed successfully. Mean operative time was 173 minutes. Mean operative blood loss was 380 cc. The transfusion rate was 1.2%. The major and minor complications rate was 2.3% and 9.2%, respectively. The reoperation rate was 1.7%. Mean hospital stay was 6.3 days. Pathological stage was pT2 and pT3 in 72% and 28% of cases, respectively. Mean Gleason score was 7. The overall positive margin rate was 17.7% (14.6% and 25.6% of pT2 and pT3 tumors, respectively). Median followup was 12 months. Of the patients 95% had prostate specific antigen less than 0.2 ng/ml. Patients were evaluated by a selfquestionnaire sent by mail before and after surgery (International Continence Society and International Index of Erectile Function-5). At a median followup of 12 months 84% of the patients were continent (no pad), 7% used 1 precautionary pad and 7% needed 1 pad routinely. At a median followup of 6 months in preoperatively potent patients (International Index of Erectile Function-5 greater than 20) the postoperative erection and intercourse rate was 64% and 43%, respectively, in those with bilateral nerve bundle preservation. Conclusions: The extraperitoneal technique is a reliable approach to laparoscopic radical prostatectomy. KEY WORDS: prostate, prostatic neoplasms, prostatectomy, laparoscopy

Radical prostatectomy is an established treatment modality for localized prostate cancer. The laparoscopic approach, which has been developed since 1998, is now regularly used at several centers.1–3 Laparoscopic radical prostatectomy can be performed by a transperitoneal or extraperitoneal approach. Extraperitoneal laparoscopic radical prostatectomy was first reported in 2001 by Bollens et al.3 The theoretical advantage of the extraperitoneal compared with the transperitoneal technique is the possibility of decreasing the risk of intra-abdominal complications, such as bowel injury.3 The extraperitoneal technique allows a direct approach to the space of Retzius and it can decrease operative time, especially in obese patients and patients with previous abdominal surgery.4, 5 Postoperatively anastomotic urinary leakage or hematomas are managed more easily because of the absence of peritoneal irritation and reflex ileus. In 2002 we decided to evaluate the advantages and the disadvantages of the extraperitoneal approach, which showed equivalent operative, postoperative and pathological results.6 Since then, 600 laparoscopic radical prostatectomies have been done with the extraperitoneal approach and evaluated prospectively in terms of operative, postoperative and pathological data. MATERIALS AND METHODS

Between 1998 and 2004, 1996 laparoscopic radical prostatectomies were performed at our institution. The last 600

procedures were performed by a total of 4 surgeons (FR, XC, EB and GV) with an extraperitoneal approach according to the Montsouris II technique.7 Table 1 lists preoperative data. Pelvic lymphadenectomy was performed at step 1 of the operation in cases with prostate specific antigen (PSA) 15 ng/ml or greater, clinical stage greater than T2a, more than 4 of 6 positive biopsies or Gleason score higher than 7. Nerve sparing procedures were performed in patients who were potent preoperatively and those with clinical stage of T1 or T2 and PSA 10 ng/ml or less. Intraoperative frozen section analysis was obtained during nerve sparing procedures. The operative technique has been described previously. Briefly, the steps of extraperitoneal radical prostatectomy are 1) creation of a preperitoneal working space with the camera or balloon, 2) port placement, 3) incision of the endopelvic fascia and lateral dissection of the apex, 4) bladder neck dissection, 5) incision of the anterior layer of Denonvilliers’ fascia and dissection of the seminal vesicles (for nerve sparing surgery coagulation is done on the vesicle and the tissues surrounding the vesicle are pushed away, so as not to injure the bundle), 6) coagulation of the prostatic pedicles with thin bipolar forceps (the lateral prostate surface is dissected in an intrafascial or extrafascial plane depending on preoperative oncological data), 7) ligation with zero polyglactin and transection of the dorsal venous complex, 8) dissection of the apex with maximal preservation of urethral length, 9) prostate removal in a laparoscopic bag via a 4 cm umbilical incision and frozen section analysis, 10) vesicourethral anastomosis with an average of 6 to 10 interrupted 3-zero polyglactin sutures to achieve a watertight anastomosis and 11) insertion of an 18Fr Foley catheter with a suction drain left in the

Submitted for publication November 29, 2004. * Correspondence and requests for reprints: Department of Urology, Institut Montsouris, 42 Blvd. Jourdan, Paris 75014, France (telephone: 33 1 56 61 66 20; FAX: 33 1 56 61 66 38; e-mail: [email protected]). 908

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EXTRAPERITONEAL LAPAROSCOPIC RADICAL PROSTATECTOMY TABLE 1. Preoperative patient characteristics No. pts Mean age (range) Mean body mass index (range) % Previous abdominopelvic surgery No. clinical stage (%): T1a–b T1c T2 T3 Mean PSA ⫾ SD (ng/ml) Mean No. pos biopsies ⫾ SD Mean No. Gleason score pos biopsies (range)

600 62 (47–73) 61 (19–32) 15 5 (8.3) 366 (61) 220 (36.7) 9 (1.5) 7.4 ⫾ 6.2 2 ⫾ 1.7 6 ⫾ 1 (4–9)

retropubic space. The bladder catheter is removed between days 5 and 8, depending on the quality of the anastomosis. Consenting patients are discharged home on postoperative day 3. The usual analgesic protocol for the first 48 hours consisted of 8 gm acetaminophen daily and 4 gm noramidopyrine daily. If necessary, subcutaneous morphine hydrochloride was administered at patient request. Postoperative pain was evaluated by a visual analog scale scored 1 to 10 and by the morphine hydrochloride requirement, Preoperative, operative and postoperative data were recorded prospectively. The conventional complication classification of Dillioglugil et al was used.8 Pathological specimens were reviewed according to the Stanford protocol. Positive surgical margins were defined as tumor on the inked surface of the specimen. Oncological results were evaluated by staging operative specimens according to the TNM 2002 classification and the last PSA level. Patients were evaluated by self-questionnaire preoperatively, postoperatively at 6 months and annually thereafter. Questionnaires included continence (International Continence Society [ICS]) and potency data. Since June 2003, a postoperative treatment protocol (10 mg tadalafil every 2 days) was started and the validated International Index of Erectile Function (IIEF)-5 was added to the questionnaire, to evaluate erectile function.9 Preoperative, operative, postoperative, pathological and functional data were gathered prospectively in an Access 97 (Microsoft, Redmond, Washington) by the team medical physicians. RESULTS

Table 1 lists patient characteristics. Intraoperative data (table 2). Radical prostatectomy was performed completely laparoscopically in 599 patients (99.8%). Conversion to open retropubic approach was required in 1 case due to laparoscopic camera breakdown. In 5 patients with previous hernia repair with mesh (unilateral in 2 and bilateral in 4) conversion to a laparoscopic transperitoneal approach was necessary. In these 5 cases it was impossible to dissect the retroperitoneal space because of postoperative fibrosis. Pelvic lymphadenectomy with frozen

section histological examination performed during the procedure was done in 107 cases (18%). A bilateral and a unilateral nerve sparing procedure was performed in 382 (64%) and 128 patients (21%), respectively, while 90 (15%) underwent operation with no nerve sparing procedure. Mean operative time for the whole procedure was 173 minutes (range 105 to 300). Mean operative blood loss was 380 cc (range 20 to 2,500). Of the patients 43 (7%) had greater than 1,000 cc blood loss. Two rectal injuries were identified intraoperatively and sutured laparoscopically in 2 layers. These 2 patients did not have a complicated postoperative course. No bowel, ureteral or nervous complications were observed. Postoperative data (table 3). No deaths and no cardiac complications were observed. Major postoperative complications occurred in 12 cases (2%), including pulmonary embolism, pulmonary edema, peritonitis and rectourethral fistula secondary to nondiagnosed rectal tears (secondary necrosis due to coagulation), vesicocutaneous fistula, symptomatic lymphocele, urinary retention and anastomotic stenosis in 1 each, and infected pelvic hematomas and prolonged ileus due to urine diffusion in the peritoneum in 2 each. In these 12 cases a total of 10 reoperations (1.7%) were necessary, including colostomy, York-Mason repair, vesicocutaneous fistula treated with open reanastomosis, vesicourethral stenosis treated with endoscopic incision, laparoscopic lymphocele marsupialization and acute urinary retention treated with endoscopic vesical clots evacuation in 1 each, and infected pelvic hematoma evacuation and endoscopic bilateral ureteral stent placement in 2 each. Minor complications were observed in 55 cases (9.2%). A total of 30 anastomotic leaks were revealed in 2 cases by persistent urine in the suction drain during 6 days, which was associated with increased serum creatinine (urinary resorption. There were 20 cases of urinary retention following bladder catheter removal, requiring new catheter placement for 1 week, 3 of lymphoceles and 2 of an umbilical port site abscess, while 7 blood transfusions (1.2%) with an average of 3 units of packed cells (range 2 to 6) were also necessary. Intravenous fluids were discontinued on day 1. Oral intake began on day 1. Mean pain ⫾ SD was scored as 2.8 ⫾ 2, 2.4 ⫾ 1.8 and 1.6 ⫾ 1.6 on days 1 to 3, respectively. Mean daily morphine requirement was 3. 0.9 and 0 mg on days 1 to 3, respectively. Only 36% of the patients received morphine during hospitalization. Mean hospital stay was 6.3 days (range 4 to 14). Mean bladder catheter duration was 7.6 days (range 3 to 20). Oncological data. Table 4 shows the results of histopathological examination of the specimens. Margins were positive in 17.7% of cases, including 14.6% and 25.6% of pT2 and pT3 tumors, respectively. Margins were less than 1 mm in 36%, between 1 and 3 mm in 40% and greater than 3 mm in 24% of cases. They were localized at the apex in 47% of cases,

TABLE 3. Complications No. Complications

TABLE 2. Perioperative data Mean min operative time ⫾ SD (range) Mean ml blood loss ⫾ SD (range) % Transfusion No. conversions: Open Transperitoneal No. lymphadenectomy No. nerve sparing (%): Bilat Unilat Mean days (range): Bladder catheterization Hospital stay

173 ⫾ 85 (95–300) 380 ⫾ 210 (20–3,500) 1.2 1 5 107 382 128

(63.6) (21.3)

7.6 (3–20) 6.3 (4–14)

Major Pulmonary embolism Pulmonary edema Rectal injury Infected pelvic hematoma Vesicocutaneous fistula Anastomotic stenosis Prolonged ileus Lymphocele Retention Minor: Retention Anastomotic leakage Wound abscess Lymphocele Reoperation in 2 cases.

1 1 4* 2 1 1 2 1 1 20 30 2 3

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EXTRAPERITONEAL LAPAROSCOPIC RADICAL PROSTATECTOMY TABLE 4. Postoperative patient characteristics No. Pts (%)

Pathological stage: pT2a pT2b pT2c pT3a pT3b Mean Gleason score (range) Pos surgical margins: pT2a pT2b pT2c pT3a pT3b Total No. Mean Gleason score 7 (range 4 to 9).

75 47 310 115 53 7

(12.5) (7.8) (51.7) (19.2) (8.8) (4–9)

5 (6.7) 7 (14.9) 51 (16.5) 31 (26.9) 13 (22.64) 107

(17.7)

lateral in 38% and posterior in 15%. Margins were diagnosed in 16.7% of patients with bilateral nerve sparing surgery, including 14.7% and 26.1% of pT2 and pT3 tumors, in 21.1% of those with unilateral nerve sparing surgery, including 17.9% and 28% of pT2 and pT3 tumors, and in 16.7% of those with no bundle preservation, including 9.8% and 26.7% of pT2 and pT3 tumors, respectively. The margin rate was 20.4% in the first, 18.3% in the second, 14.1% in the third and 18.9% in the last 150 cases. Of the patients with negative frozen section analysis and definitive histological examination 107 showed stage N0. A total of 14 patients (2.3%) received adjuvant therapy, including external beam radiation in 11 and hormone therapy in 3. PSA measurements were available in 545 patients at a median followup of 12 months. Of the patients 95% had PSA less than 0.2 ng/ml. There were no port site metastasis. Functional data. Continence: Of the patients 83% returned the continence questionnaires. At a median followup of 12 months 84% of the patients were continent with no pad use, 7% used 1 pad as a precaution against possible urine leakage and 7% used 1 pad routinely. No patient had an artificial sphincter. Potency: A total of 231 patients were evaluated with the IIEF-5 questionnaire preoperatively, of whom 139 underwent surgery with bilateral nerve bundle preservation. In the 89 patients who were potent preoperatively and had an IIEF-5 of greater than 20 postoperative erection and intercourse rate without the assistance of intracavernous medication and with 10 mg tadalafil every 2 days was 64% and 43%, respectively, at a median followup of 6 months. DISCUSSION

An advantage of the extraperitoneal compared with the transperitoneal technique is to decrease the risk of intraperitoneal complications.3 Direct bowel injury remains possible via the extraperitoneal approach during trocar placement. Therefore, in our opinion after space creation it is important to assess the position of the peritoneum and insert the trocars away from it under visual guidance. The risk of epigastric injury may occur during either approach. In our extraperitoneal experience the epigastric vessels are clearly seen and can be easily coagulated with bipolar forceps. The risk of ureteral damage is reported in 0.7% of cases using the transperitoneal approach with 75% of these injuries occurring during posterior dissection of the vesiculodeferential junction or lateral vesical peritoneum.10 The extraperitoneal approach may decrease this type of complication. In this series no ureteral injury occurred. Rectal injury during laparoscopic prostatectomy has been reported in 0.3% to 2.1% of cases.11 Obviously the extraperitoneal compared with the transperitoneal approach does not decrease the risk of rectal injury but it may change the clinical presentation. In our series 2

patients presented with rectal necrosis secondary to intraoperative coagulation, of whom 1 presented with peritonitis on day 5 and the other had a rectourethral fistula without abdominal symptoms. Previous mesh hernia repair may be considered a contraindication to the extraperitoneal approach due to difficulty in creating a working space. In our experience 5 patients required conversion to a transperitoneal approach. It may appear that the extraperitoneal approach provides a smaller working space. However, our experience shows that the size of the extraperitoneal space can be almost as large as that obtained during the transperitoneal approach with the added benefit that the bowel does not encroach on the operative field. In our experience the anastomosis is performed with tension in 10% of cases. There are a few maneuvers that may help, including leveling the table, emptying the bladder, freeing the bladder attachments, enlarging the bladder neck and lowering extraperitoneal pressure. Any of these maneuvers is usually enough to solve the problem. We dissect the prostate in antegrade fashion, as reported by Bollens et al.3 Dubernard et al proposed retrograde dissection as it is done in retropubic radical prostatectomy.12 Rassweiler et al proposed a transperitoneal approach with direct access to the space of Retzius and bladder neck incision, followed by transvesical access to the 2 vas deferens and seminal vesicles.13 In our opinion this approach is similar to the extraperitoneal technique without the advantages of a strict extraperitoneal route, which is especially important because of the lower risk of bowel injury. Functional results must be clearly defined. The variation in definitions and methods used to assess results in the different series explain the difficulty with comparison. Defining continence 1 year after laparoscopic radical prostatectomy as no pad use, Rassweiler14 and Eden15 et al reported a 91% and 90% rate, respectively. Using the ICS validated self-questionnaire prospectively, Guillonneau et al found that 82.3% of patients were continent 1 year after laparoscopic radical prostatectomy.16 Using a self-questionnaire Salomon et al reported that 65.8% of patients were continent 1 year after prostatectomy performed via a retropubic, perineal or laparoscopic approach.17 Similarly postoperative sexual function depends on preoperative status, bundle preservation and postoperative management, including drugs (oral treatment and injections) and psychological support. Guillonneau et al reported a 66% intercourse rate in patients who were potent preoperatively after bilateral nerve sparing surgery with the help of sildenafil, if necessary.18 In their initial series Rassweiler et al reported that 4 of 10 patients achieved “sufficient erections” with sildenafil after bilateral or unilateral nerve sparing surgery.19 Katz et al reported a 23% rate of intercourse in 26 preoperatively potent patients evaluated with a questionnaire after 1 year.20 In this series in the 89 preoperative potent patients with an IIEF-5 of greater than 20 the postoperative intercourse rate was 43% with tadalafil at a median followup of 6 months. The questionnaires used and time of data assessment should be analyzed when comparing functional results. The use of international validated selfquestionnaires (ICS and IIEF-5) before and after treatment would be useful if we want to compare not only surgical variations, but also the different techniques of treating localized prostate cancer. CONCLUSIONS

Our experience of more than 6 years has proved that laparoscopic radical prostatectomy is an evolving procedure and a reliable technique. Extraperitoneal laparoscopic radical prostatectomy is a variation that offers the advantages of a minimally invasive technique with no risk of intraperitoneal organ injury. Long-term oncological data are needed to confirm the encouraging short-term results. Functional results

EXTRAPERITONEAL LAPAROSCOPIC RADICAL PROSTATECTOMY

are a great concern for patients who are younger and more informed. The prospective use of standardized selfquestionnaires is necessary to evaluate, compare and improve the different options for prostate cancer treatment. REFERENCES

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