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Keywords:

  • robotics;
  • Veil of Aphrodite;
  • outcomes;
  • prostatectomy;
  • surgical margins

Abstract

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONFLICT OF INTEREST
  8. REFERENCES

OBJECTIVES

To report updated results, at 1 year of follow-up, of a modified nerve-sparing robotic radical prostatectomy that preserves the lateral prostatic fascia (Veil of Aphrodite).

PATIENTS AND METHODS

From January to December 2003, 154 consecutive men had a Vattikuti Institute prostatectomy with Veil of Aphrodite nerve-sparing by one surgeon. A prospective database recorded patient demographics, intraoperative, peri-operative, and pathological variables. Peri-operative complications were recorded using the Clavien classification. Patients had serum prostate-specific antigen (PSA) levels measured every 3 months and self-administered the International Prostate Symptom Score and Sexual Health Inventory for Male questionnaires before and at 1 year after surgery.

RESULTS

The men had a mean age of 57.4 years, a mean body mass index of 27.2 kg/m2, and a mean PSA level before surgery of 5.11 ng/mL. The mean operative duration was 122 min. At 1 year, 96% of the men reported having had intercourse and 71% had recovered normal erectile function. One man had a Clavien grade II complication, 4.6% of men with organ-confined disease had positive surgical margins, and no patient had a PSA recurrence at 12 months; 97% of the men were continent at 1 year, and the median time to continence was 14 days.

CONCLUSION

Veil of Aphrodite nerve-sparing surgery provides better recovery of sexual function at 1 year than in contemporary series from centres of excellence, without compromising cancer control and urinary function.


Abbreviations
RP

radical prostatectomy

VIP

Vattikuti Institute prostatectomy

NSS

nerve-sparing surgery

SHIM

Sexual Health Inventory for Male

INTRODUCTION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONFLICT OF INTEREST
  8. REFERENCES

Robotic radical prostatectomy (RP) has been embraced by several centres in the USA as the preferred surgical approach for organ-confined prostate cancer, as early reports suggested that it gave better results than retropubic RP [1]. As more prostate cancers are being diagnosed at an earlier stage and in younger patients, quality of life, especially sexual and urinary function, assumes greater importance for both patients and physicians. Several technical modifications have been described with a view to improving quality-of-life outcomes, e.g. preserving accessory pudendal arteries [2], use of methylprednisolone [3], use of CaverMap (Bluetorch Technologies, Ashland, MA, USA; an intraoperative tool for nerve stimulation and tumescence monitoring), and preserving the bladder neck. We previously reported on the safety and feasibility of preserving the prostatic fascia (Veil of Aphrodite) during Vattikuti Institute Prostatectomy (VIP) [4]. We describe the technique of Veil of Aphrodite nerve-sparing surgery (Veil NSS), and report on 154 consecutive men at 1 year after this surgery.

PATIENTS AND METHODS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONFLICT OF INTEREST
  8. REFERENCES

Between January and December 2003, 243 consecutive men had VIP by one surgeon (M.M.). Of these, 154 men with low- or intermediate-risk disease by the D’Amico classification [5] (Gleason score ≤ 7, no palpable nodule, <25% involvement of biopsy cores) had Veil NSS as previously described. All were placed on the ‘robotic prostatectomy pathway’ followed at our institution. A prospective database included preoperative demographics (age, body mass index, serum PSA level, biopsy Gleason sum, clinical stage), operative variables (console time and intraoperative blood loss), and peri-operative variables (hospital stay, duration of catheterization, and need for transfusion). Peri-operative complications were recorded according to the Clavien classification [6]. The prostate was examined pathologically according to standardized protocols reported previously [7]. In contrast to our previous practice, tumour at the inked surface represented a positive margin.

Veil NSS is a modification of our earlier reported VIP technique [8]. The patient position, port placement and set up of the da Vinci® robot (Intuitive Surgical, Sunnyvale, CA, USA) are as described previously. We first incise the peritoneum over the bladder to approach the space of Retzius, and the fat over the prostate is cleared. The dorsal vein complex is not ligated and the endopelvic fascia is not incised; this reduces the traction on the neurovascular bundles and accessory cavernosal nerves when the prostatic fascia is dissected off the prostatic capsule. The bladder neck is divided at the prostatovesical junction; at the time of bladder neck transection, it is important to carry the incision posteriorly up to the level of insertion of the seminal vesicles into the prostate but no lower, to prevent thermal injury to the pelvic plexus, which is closely related to the tips of the seminal vesicles. After this step, no further monopolar coagulation is used and the rest of the dissection proceeds using bipolar forceps and scissors. After dissecting the vasa and seminal vesicles, the posterior layer of Denonvilliers’ fascia is exposed. A transverse incision is made in this fascia, staying close to the inferior surface of the prostate. A plane is then developed between the posterior surface of the prostate and Denonvilliers’ fascia, anterior to the perirectal fat. This plane is then extended as far distally as possible. Using blunt dissection Denonvilliers’ fascia is swept off the posterior prostate laterally until the fascia reflects off the posterolateral border of the prostate. At the conclusion of this posterior dissection, the two pillars of prostatic fascia are clearly demarcated on either side. Subsequently, the base of the seminal vesicle is retracted superomedially by the assistant. The neurovascular bundle runs along the posterolateral aspect of the prostate enclosed by the prostatic fascia medially and levator layer of the periprostatic fascia laterally, and anterior layer of Denonvilliers’ fascia posteriorly. The dissection for the Veil of Aphrodite begins by entering the plane between the prostatic fascia and the capsule of the prostate, starting inferolaterally where the prostatic fascia reflects off the prostate, and proceeds in antegrade fashion. The prostatic pedicle is not ligated en masse, rather small arterioles are coagulated using bipolar coagulation and cut as they enter the posterolateral surface of the prostate. These micropedicles are encountered only in the initial 2–3 cm of dissection and from there on, the plane is avascular except anteriorly where the fascia is fused with the puboprostatic ligament, capsule and venous plexus. This dissection is facilitated by the magnification of the robotic camera and the endowristed instruments. Once this has been done, blunt dissection of the neurovascular bundle and contiguous prostatic fascia is easy, until the prostatic fascia up to and including the ipsilateral pubourethral ligament (pubourethral aspect of puboprostatic ligament) is mobilized in continuity off the lateral aspect of the prostatic apex. When done correctly an intact ‘veil’ of periprostatic tissue extends from the pubourethral ligament to the bladder neck. The rest of the procedure, including apical dissection, urethral transection and anastomosis, is as described previously.

Serum PSA was measured in all men at 1 month after surgery and every 3 months thereafter. Sexual and urinary outcomes were evaluated using validated questionnaires; the Sexual Health Inventory for Male (SHIM) and IPSS questionnaires. Patients self-administered these questionnaires before and at 1 year after surgery. Sexual function was assessed using two endpoints. Intercourse was defined by an answer of >2 (‘sometimes’ or ‘more often’) on question 2 of the SHIM questionnaire (‘When you had erections from sexual stimulation, how often were your erections hard enough for penetration?’). Recovery of normal erections was defined by a SHIM score after surgery of >21; this score was validated by Rosen et al.[9] to indicate the absence of erectile dysfunction. The men were considered continent if they used no pads or used a single liner for security purposes only, and failed to leak urine on provocative manoeuvres.

RESULTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONFLICT OF INTEREST
  8. REFERENCES

Table 1 shows the demographic characteristics of the patients. The mean age of the men was 57.4 years, and 60 (39%) had one or more comorbidities (Table 1). The mean operative duration was 122 min and the mean blood loss was 111 mL. The mean duration of catheterization was 7.2 days, and the mean length of hospital stay was 1.1 days.

Table 1.  Characteristics of the 154 patients who had Veil NSS
Variable
Mean (range):
Age, years 57.4 (42–68)
PSA, ng/mL  5.1 (0.8–13.3)
Gleason, sum  6.2 (6–7)
Body mass index, kg/m2 27.1 (21–36)
Race, n
 Caucasian140
 African American  9
 Asian  5
Comorbidities, % 39
 Hypercholesterolaemia 28
 Hypertension 26
 Smoking  11
 Coronary artery disease  8
 Diabetes mellitus  4
Preoperative:
SHIM
≥22 (No erectile dysfunction) 112
<22 (erectile dysfunction) 42
IPSS, mean (range)  7 (0–26)

Overall, 112 men had a baseline SHIM score of >21, and 42 had a SHIM of <22. Twenty-four men had unilateral and the remainder had bilateral Veil NSS. Ten men did not return the SHIM questionnaire or returned an incomplete questionnaire; 102 men with normal sexual function before surgery (SHIM >21 without phosphodiesterase-5 inhibitors) completed both questionnaires and were eligible for analysis. Of these men, 98 (96%) reported a score of >2 on question 2 of the SHIM and 72 (71%) had a SHIM score after surgery of >21 with or without potency-enhancing medication. The median SHIM score after surgery was 22 (Table 2). For the IPSS, 27 patients did not return the questionnaire and/or did not complete the IPSS and questions on urinary control. The mean IPSS was 6 before and 3.4 after surgery. Five men (3%) were wearing pads and 149 (97%) had complete urinary control at 1 year after surgery. The mean (median, range) time to urinary continence was 28 (14, 0–100)  days; 37 men (29%) were continent and pad-free at the time of catheter removal.

Table 2.  Sexual function and urinary outcomes at 12 months after Veil NSS
Patient outcomes
  1. PDE-5, phosphodiesterase-5; *defined as an answer of ≥2 to question no. 2 of the SHIM questionnaire; †defined as a SHIM score of ≥ 22.

No pads, n(%)122 (97)
Time to continence, days
 mean (median; range) 28 (14; 0–100)
Sexual function, n(%)
 Intercourse* 98 (96)
 Normal erections 72 (69)
 Using PDE-5 inhibitors 45 (45)
SHIM score
 Mean before surgery 24.3
 Mean after surgery 20.6
 Median after surgery 22

Seven men (5%) with organ-confined prostate cancer had positive surgical margins (Table 3). The mean prostate weight was 49 g and the mean tumour volume was 7 mL. One man with seminal vesicle invasion had a PSA recurrence at 1 year after surgery. One man needed a blood transfusion after surgery. There were no Clavien grade III or IV complications. One man had a Clavien grade IIb complication; a small bowel injury that occurred during laparoscopic lysis of adhesions for port placement, and unrelated to the robotic part of the operation. Four men (2.5%) had a Clavien grade I complication (urinary leaks in three and a suture abscess in one). Eight men (5%) had peri-operative retention of urine and three (2%) had an anastomotic stricture that required endoscopic incision. Two men developed incisional hernias at the umbilical port-site at 6 and 10 months after surgery; these were repaired electively.

Table 3.  Pathological variables and oncological outcomes in 154 patients who had Veil NSS.
Pathological variables
  • *

    in pT2 disease;

  • †Patient had pT3b disease.

Gleason sum
 6105 (68)
 7 43 (28)
 ≥8  6 (4)
Prostate weight, g (range) 48.6 (21–130)
Positive surgical margins*  7 (5)
 Apex  6
 Posterolateral  1
PSA recurrence  1

DISCUSSION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONFLICT OF INTEREST
  8. REFERENCES

Since the advent of PSA screening and aggressive strategies for prostate biopsy, most men undergoing RP have normal sexual and urinary function. In these men, cancer-specific mortality after RP is <5% at 10 years, and quality of life, especially related to sexual and urinary function, is an important consideration [10]. Surgical techniques are being constantly modified in an attempt to achieve immediate continence and sexual function, and surgeons have generally been much more successful at achieving the first objective.

It is a sobering fact that RP results in impaired erectile function in most men. Thus, while expert surgeons achieve a high potency rate, the quality of erections is impaired in many patients, and it is unlikely that these results are because of technical misadventures. Several investigators have reported on the presence of nerves within the lateral prostatic fascia [11,12]. We reasoned that the excellent visualization of periprostatic anatomy afforded by the InsiteTM vision system and enhanced dexterity of movement provided by the endowristed instruments of the da Vinci surgical system would enable us to preserve the nerves within the prostatic fascia (Veil of Aphrodite); this might result in better erectile function.

In a pilot study we reported on the feasibility of Veil NSS and showed that, in a few selected patients, this significantly improved erectile function in comparison to conventional NSS [13]. However, intrafascial dissection comes closer to the cancer and might compromise surgical margins. In an analysis of 278 whole-mount RP specimens with negative margins, Emerson et al.[14] showed that the median distance of the cancer from the capsule was 0.5 mm and that all cancers were within 5 mm of the margins of resection. In a similar study of patients who had Veil NSS and conventional NSS, Savera et al. have shown that the mean distance from the tumour to the resection margin was 0.3 mm with Veil NSS and 1.4 mm with conventional NSS (unpublished data). As RP is more like Mohs’ surgery than a ‘radical’ cancer operation, would Veil NSS become a ‘cancer-sparing operation’ much as conventional NSS was thought to be in its earlier days? The present study expands on our earlier study, focusing particularly on the adequacy of resection and the results with urinary control.

Aware of the potential for positive surgical margins, as the plane of dissection for the Veil of Aphrodite is closer to the capsule of the prostate than conventional NSS, we restricted the Veil NSS technique to men with low- and intermediate-risk cancers by the D’Amico classification. Supporting our selection criteria, 95% of the men had organ-confined disease on final analysis. We did not take peri-apical biopsies routinely, nor did we use these when taken to determine margin status. In the present study, unlike in our previous studies, the presence of tumour cells in contact with the inked surface was designated as a positive surgical margin. By this definition, seven men with organ-confined disease (5%) had a positive surgical margin, six at the apex, and one posterolaterally. Thus, no patient had a positive margin in the region of the Veil of Aphrodite. At 1 year of follow-up, the only PSA recurrence was in a man with seminal vesicle invasion. The low incidences of positive surgical margins and of biochemical failure suggest strongly that, at least in our hands, intrafascial dissection did not compromise cancer control. Figure 1 shows the plane of dissection for Veil NSS. The prostatic capsule is clearly visible and there is no evidence of capsular incision or positive margins.

image

Figure 1. Photomicrograph of the Veil of Aphrodite showing the plane of dissection on the capsule of the prostate, and absence of malignant glands at the inked surface. Haematoxylin and eosin, × 100.

Download figure to PowerPoint

Some reports suggest that preserving the neurovascular bundle might improve urinary continence [15], and perhaps preserving additional nerves within the prostatic fascia might improve this further. At 12 months, 97% of the present patients had complete urinary control, similar to results from other centres of excellence (Table 4). In the present study, the median time to pad-free status was 14 days (mean 4 weeks; range 0–100 days), and 29% of patients had complete urinary control at the time of catheter removal and never needed to wear pads. Table 4 compares the present results to contemporary series of open, laparoscopic and robotic RP. These results suggest that urinary continence is restored sooner with Veil NSS. Further studies are needed to confirm and elucidate the physiology of these results.

Table 4.  Functional and oncological outcomes in contemporary series of open, laparoscopic and robotic RP
SeriesNMean follow-up, monthsPositive SMs, %Positive SMs in T2 patients, %PSA recurrence at 1 year, %Intercourse rates at 1 year, %Patients with normal SHIM/ IIEF, %Pad-free at 1 year, %Pad-free at catheter removal, %
  1. SM, surgical margin; *Patients with T2 disease; †erections and intercourse.

[16]22512NANANA428NANA
[17]24052NANANANA33 (52 months)NANA
[18]5503616.7 914*66NA82NA
[19]134122516.8 1156NA86NA
[20]4381230 713.2NANA90NA
[21] 701221 6.1NA33 (6 months)NA90 (6 months)NA
[22] 52 6NANANANA17 (6 months)NANA
[23] 60 917 4.5NA33 (9 months)NA76 (3 months)NA
[24]200 9.721 5.7 5NANA9827
[25] 401530 8NA22 (15 months)NA84 (15 months)NA
[26]200 7.9 6 3 468NA90NA
[27]53012 9NA 4 (20 months)78NA98NA
Present study15412 6.4 4.6 09671 (12 months)9729

The motivation to develop Veil NSS was to improve erectile function outcomes. Table 4 shows the sexual function outcomes in the present study group. At 1 year of follow-up, 96% of the men reported having had intercourse. However, only 71% reported recovery of normal erectile function, defined as a SHIM score of >21, and only 56% achieved these scores without phosphodiesterase inhibitors. Figure 2 compares whole-mount pathology in a man who had conventional NSS on the left and Veil NSS on the right. Figure 2a shows the conventional NSS side; the prostatic fascia is on the prostate with the nerves stained by S-100 (arrows), while Fig. 2b shows the Veil NSS side, with an intact capsule and no nerves, indicating that these nerves were ‘preserved’in situ in Veil NSS.

image

Figure 2. Whole-mount and representative photomicrographs showing the difference in the number of nerves present on the prostate specimen with conventional and Veil NSS. S-100, × 200.

Download figure to PowerPoint

In conclusion, the present analysis of an expanded group of patients reinforces our earlier observation that men who have Veil NSS at our institution have excellent recovery of erectile function (both intercourse rates and return of normal erections) at 1 year after surgery, without compromising surgical margins and oncological outcomes. Peri-operative complications are rare and urinary function outcomes are similar to those from the prostate cancer treatment ‘centres of excellence’.

REFERENCES

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONFLICT OF INTEREST
  8. REFERENCES
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