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Keywords:

  • impotence;
  • laparoscopy;
  • prostatectomy;
  • urinary incontinence;
  • urogenital surgical procedures

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions
  8. Acknowledgments
  9. References

Objective:  As more patients are diagnosed with prostate cancer at an early stage, it is becoming increasingly important to refine the technique of surgical excision. For this purpose we have generated objective data comparing three different surgical approaches used by three experienced surgeons.

Methods:  We prospectively compared three contemporary personal series of 50 consecutive radical prostatectomy (RP) patients. The health-related quality of life was evaluated preoperatively and in months 1, 3, 6, 12 and 24.

Results:  Considering in turn the patients undergoing retropubic, perineal and laparoscopic RP, the median procedure time was 2 h and 27 min, 1 h and 50 min and 4 h, with a transfusion rate of 2, 0 and 8%, respectively. In the perineal group there were more wound infections. Median catheter drainage was 7, 10 and 7 days and zero, 13 and one patients needed reinsertion of a catheter. Early continence varied considerably, with 57.4, 11.4 and 6.3% of patients pad-free after 1 month, but there were no differences in social continence (zero or one pad) with 97.8, 97.8 and 91.9% after 2 years. The Litwin score for incontinence (preoperative minus postoperative) was −24, −41 and −63% after 1 month and −13, +3 and −29% after 2 years. Twenty-nine, five and 15 patients had a preoperative five-item version of International Index of Erectile Function (IIEF-5) score of ≥17 points and a nerve-sparing procedure. After 2 years, 48.1, 0 and 0% had an IIEF-5 score of ≥17 points without the use of phosphodiesterase type 5 (PDE-5) inhibitors, but when including patients using inhibitors there were no significant differences.

Conclusions:  A comparison of morbidity, short-term convalescence and long-term side-effects of different surgical techniques is strongly biased by both the preoperative status of patients and the skill of the surgeons. Overall, we found some differences in the short-term results (e.g. early continence) and comparable long-term results.


Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions
  8. Acknowledgments
  9. References

As more patients are diagnosed with prostate cancer at an early stage, it is becoming increasingly important to refine the technique of surgical excision. These refinements should result in better cure rates, lower complication rates and the fewest possible long-term side-effects. The individual surgeon has the responsibility for checking that his/her individual rates of cure, complications and long-term side-effects are comparable to the contemporary standard of care. For this purpose, we have generated objective data comparing three different surgical approaches used by three experienced surgeons.

Methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions
  8. Acknowledgments
  9. References

A consecutive personal series of 50 patients for each of the three surgeons was compared prospectively according to the same protocol of data acquisition (and handling of the specimen by the pathologist). The study was carried out in three large community hospitals. One surgeon (N.S.) in Salzburg used the retropubic technique as described by P.C. Walsh (RS group), the second surgeon (H.K.) used the perineal approach in Hof (PH group) and the third surgeon (G.J.) has a worldwide reputation for the use of laparoscopy for different urological procedures and performed his personal series of laparoscopic prostatectomies in Linz (LL group).

There were differences in the previous experience of the surgeons. Whereas the surgeons using the retropubic and the perineal techniques both had a personal experience of more than 500 cases, the surgeon in Linz had a personal experience of only 89 laparoscopic radical prostatectomies when the study started.

The pain score (ranging 0–10, ‘no pain’ to ‘maximal pain’) was taken by the nurse on night duty. Hemoglobin was measured on the day before surgery and on the day before discharge from the hospital (approximately 1 week after surgery).

To objectively evaluate the long-term side-effects, we used validated questionnaires preoperatively and after 1, 3, 6, 12 and 24 months. For erectile function, the five-item version of International Index of Erectile Function (IIEF-5) score was used, specifically the five questions evaluating the erectile domain. The patients were asked to fill in this form twice each time, once describing the status without phosphodiesterase type 5 (PDE-5) inhibitors and a second time, if applicable, with the use of inhibitors. For urinary function and bother and bowel function and bother, the University of California, Los Angeles Prostate Cancer Index (UCLA-PCI), as described by Litwin et al.,1 was used. The question about the use of pads was modified slightly to generate more detail (no pads, one pad, two pads, three pads or more).

The quality of the data was checked by all three authors. To make sure that the surgical series were really consecutive, without the exclusion of complicated cases, the operating room records were cross-checked. To make sure that the patient records were encoded correctly, each surgeon chose five of another surgeon's 50 patients, and was given access to the complete original medical records and the completed questionnaires to check the correctness of the data.

The data were analyzed using the SPSS statistical package (version 12.0.1; SPSS, Chicago, IL, USA). A non-paired Student's t-test (two-sided) was used to determine if average values were different. For the cross-tables, the χ2 and Fisher's exact tests were used.

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions
  8. Acknowledgments
  9. References

Preoperative data

There was a small but significant difference in mean age and body mass index (BMI) between RS (63 years, 26.0 BMI) and PH (66, 27.8) but not between the other groups. The preoperative hemoglobin was significantly higher in RS (14.9 g/dL) and in LL (15.1) in comparison to PH (14.4). No significant difference was seen in preoperative prostate-specific antigen (PSA; 8–8.9) although eight patients in the PH group and four patients in the LL group had had a previous transurethral resection of the prostate (TURP). The Gleason's score sum of the biopsy was significantly lower in RS (5.2) and in LL (5.9) in comparison to PH (6.1). There were no significant differences in the number of poorly differentiated tumors. The number of T1c tumors was different in all groups (36/50 RS, 24 PH, 49 LL).

Overall, there were only small differences between RS and LL, but the PH group was significantly worse in many prognostic parameters.

Perioperative data

Large differences were found in the procedure time, the perineal approach being the fastest technique (median, 1 h and 50 min) and the laparoscopic approach the slowest (median, 4 h).

Blood loss was best measured by subtracting the preoperative hemoglobin from the value at discharge (means: −3.68 RS; −2.44 PH; −3.58 LL). One, zero and four patients received transfusions in the RS, PH and LL groups, respectively.

Pain medication on postoperative day 1 was most intense in the RS group (mostly peridural catheter) which resulted in the lowest pain score (mean, 1.050, not significantly different to the 1.672 mean of the PH group). The LL group had the least pain medication, and this resulted in a significantly higher pain score than the other groups (mean, 4.052). On day 5 no peridural catheters or morphiates were used in any group. Again, the RS group had the lowest (0.483) and the LL group the highest pain score (1.672), which may be due to the imprinting of the pain sensation.

Wound healing was not a problem for any RS or LL patients, whereas 10 patients in the PH group experienced wound infections although only two needed surgical therapy.

A preceding cystogram was always done before catheter removal. The median time for urinary catheter drainage was 7 days in the RS and LL groups. No patient (RS) and one patient (LL) needed reinsertion of a catheter due to retention. Forty-three (RS) and 44 (LL) out of 50 catheters were removed by day 7. In the PH group, the median time of catheter removal was 10 days. Four patients needed reinsertion of a catheter due to retention and seven patients had a suprapubic tube inserted due to urinary leak at the anastomosis an average of 16.1 days after surgery which was left on continuous drainage for an average of 34.7 days.

The weight of the removed prostates did not differ significantly (54.3 g RS, 51.1 g PH, 60.2 g LL). There were also no differences in the rate of positive margins (13, 13 and 14 out of 50), but the average Gleason's score sum was higher in the PH group (6.7) compared to RS (5.7) and LL (6.0). There were no differences in the rate of positive margins in nerve-sparing and non-nerve-sparing procedures.

Postoperative data

Incontinence

In the RS, PH and LL groups, 57.4, 11.4 and 6.3% of patients were not using pads after 1 month, 66.7, 28.3 and 16.7% after 3 months, 79.2, 60.9 and 37.5% after 6 months, 88, 89.6 and 50% after 1 year and 79.2, 80 and 50% after 2 years, respectively.

Patients never using more than one pad are depicted in Figure 1.

image

Figure 1. Patients who never use more than one pad.

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Litwin's 1994 UCLA score for incontinence was calculated from the answers to five questions (loss of urine, urinary control, pads, wetting pants and problems with loss of urine during sexual activities). The last question being irrelevant for most patients, who had no sexual activities, we therefore calculated the UCLA score with only four questions. The percentage change was −23.8 (RS), −41.5 (PH) and −63.5% (LL) at 1 month, −20.9, −30.7 and −49.3% at 3 months, −13.6, −10.6 and −34.7% at 6 months, −12.6, +5.3 and −26.4% at 12 months, and −12.6, +2.6 and −29% at 24 months, respectively. These differences were significant at all times between all groups except at 3 and 6 months between the RS and PH groups. The curves for urinary bother are very similar. The differences between RS and PH were not significantly different at any time, but LL was significantly approximately 20% lower than the other two.

Bowel problems

Generally, there were only minor changes in bowel habits. Most questions and the score were not significantly different after more than 6–12 months. The early postoperative results gave less reduction of bowel function in the RS group than in the PH and/or LL group but the overall reduction in function and bother was moderate (−5 to −20%) after 1 and 3 months.

Erectile function

Erectile function was measured with the IIEF-5 questionnaire. According to Rosen et al.., patients with erectile function can be divided into six groups2 and those with no or only slight erectile dysfunction (17 points or more) were considered potent. There were significant differences in the preoperative scores with 80 (RS), 38 (PH) and 50% (LL) of patients potent.

Erectile function was compared for the preoperatively potent patients who had a nerve-sparing procedure on at least one side. As these were only 29 (RS), five (PH) and 15 (LL) patients (26, two, six bilateral) these data must be considered with caution. Without PDE-5 inhibitors, 12 out of 29 patients regained potency after 1 year, and 13 out of 27 patients (48.1%) after 2 years in the RS group, but not a single patient regained potency in the other groups. These differences disappeared when the use of PDE-5 inhibitors was included (18/27 RS, 1/2 PH, 6/9 LL).

Like the UCLA score, the IIEF-5 score may be expressed as a percentage by simply multiplying the score by four, the maximum of 25 points in the five questions thus resulting in a score of 100%. The percentage change between the preoperative score and the postoperative score is shown in Figure 2. It is interesting to note that there was only a 10–20% reduction in the IIEF-5 score after 2 years.

image

Figure 2. Percentage change in five-item version of International Index of Erectile Function (IIEF-5) score (including patients using phosphodiesterase type 5 [PDE-5] inhibitors).

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Discussion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions
  8. Acknowledgments
  9. References

Our study clearly demonstrates the problems of comparing different surgical techniques. There are several factors which make it almost impossible to determine which results are due to surgical technique, surgical skill or patient selection. Neither patients nor surgeons agree to randomize the surgical technique and therefore a selection bias is always present. A case-control design would try to minimize the effects of the selection bias but then the surgeon may select by outcome, excluding complicated cases. We therefore chose to compare consecutive personal series, thereby comparing the results of three different surgeons using three different surgical techniques which were obtained simultaneously during a certain time span (approximately 6 months). Furthermore, we have generated objective data which every individual surgeon may use in order to ascertain that his/her individual rate of cure, complications and long-term side-effects are comparable.

The procedure time of laparoscopic prostatectomy in our series was longer than in most concurrent publications. This is at least partially due to the learning curve of the surgeon. Even a surgeon with extensive experience in laparoscopic techniques for more than a decade has not reached his best personal procedure time after only 89 cases. We therefore draw the conclusion that publications describing a learning curve of approximately 21 cases3,4 are misleading.

Postoperative pain cannot be compared unless equal pain medication is given. Webster et al.. have demonstrated that there is no significant and meaningful difference in pain scores between robot-assisted laparoscopic radical prostatectomy and retropubic radical prostatectomy5 when equal amounts of pain medication are given. Our data also cannot confirm the commonly expressed opinion that patients may need less pain medication after laparoscopic procedures.

Another common supposition is that, because the urethrovesical anastomosis is technically easier in perineal prostatectomy, it is generally thought to be watertight sooner and the early continence rate is thought to be better than in retropubic or laparoscopic techniques. In our series, there was instead longer and more complicated urinary catheter drainage following the perineal technique. Nevertheless, as for most other findings in our study, it is difficult to determine how much of this is due to surgical skill and how much to the technique itself, but undoubtedly drainage of urine through the wound does not occur with the other techniques.

Delay in full continence after laparoscopic radical prostatectomy has been described by some authors.6,7 Even one of the pioneers of laparoscopic radical prostatectomy reported a pad-free rate of 65.8% after 1 year.8 Data on early continence after perineal prostatectomy are scarce, but Yang et al.. confirm our findings with 65.1% recovery of the baseline Expanded Prostate Cancer Index Composite (EPIC) urinary score after 6 months9 and Harris reported a pad-free rate of 38, 65, 88 and 96% at 1, 3, 6 and 12 months in a single-center, one-author report.10 Several factors may have contributed to the observed large differences in early continence, including differences in preoperative prognostic parameters (the PH group being significantly worse), differences in the frequency of nerve-sparing procedures (the RS group having the highest frequency) and technical details in the construction of the bladder neck and anastomosis. How much each factor contributes to the observed large differences in early continence is a matter of speculation and there is no agreement among the three authors.

Our rate of positive surgical margins of 26–28% without differences between the groups may not be ideal, but a look at the Mayo Clinic series of 7268 men with a positive surgical margins rate of 38% demonstrates that we are in good company.11

Bowel bother and function was reduced only slightly and more-or-less returned to the preoperative status by 3 months, which confirms the findings of Litwin et al..12 Even for the perineal technique, the reduction of bowel function was only slight and returned to normal after a few months, which is in accordance with the experience of Duke University.13

Potency is the most difficult issue to examine as, in our experience, many patients with very little erectile function give a positive answer to the question about sexual intercourse. Using the IIEF-5 questionnaire, 66% reached the definition of potency (≥17 points) in the RS and LL groups which is in line with the Johns Hopkins experience with laparoscopic prostatectomy (64% using the EPIC score).14 The observed differences without the use of PDE-5 inhibitors may be due to the fact that most patients in the PH and LL groups had unilateral nerve sparing only.

Conclusions

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions
  8. Acknowledgments
  9. References

A comparison of morbidity, short-term convalescence and long-term side-effects of different surgical techniques is strongly biased by both the preoperative status of patients and the experience and skill of the surgeons. The frequency of nerve-sparing procedures, gentle tissue handling and small technical details may also have an impact on the results. These factors may indeed be more important than the route of access. Overall, we found some differences in the short-term results (e.g. early continence) and comparable long-term results.

Acknowledgments

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions
  8. Acknowledgments
  9. References

The authors have no industrial links or affiliations.

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions
  8. Acknowledgments
  9. References