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Keywords:

  • transrectal ultrasonography;
  • prostate;
  • biopsy;
  • sedation;
  • satisfaction

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References
  9. Authors

Objective To determine the acceptability and patient satisfaction of transrectal biopsy undertaken with the patient under sedation.

Patients and methods A retrospective questionnaire was sent to 100 patients who had undergone transrectal biopsy between January and August 1998. Levels of patient acceptability and satisfaction were assessed using visual analogue scales (VAS, with a maximum score of 10 being the least satisfactory or acceptable) and direct questions about the side-effects of the procedure. A subsequent prospective study was undertaken on 130 patients undergoing transrectal biopsy with sedation between January 1999 and January 2000.

Results The mean score for patient discomfort with sedation was 1.5, compared with 3.5 with no sedation. The overall satisfaction score improved from 3.1 to 0.9 with sedation. Complication rates were comparable, although slightly higher overall in the prospective group.

Conclusion Sedation can significantly reduce patient discomfort and make the transrectal biopsy a more satisfactory experience for the patient. This is particularly important in the proportion of men who need to be considered for repeat biopsies.


Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References
  9. Authors

TRUS-guided prostatic biopsy is the procedure of choice in diagnosing prostate cancer. There is a recognized associated morbidity, with mild complications in ≈ 60% and more severe complications in up to 5% of men [1,2]. Whilst accepted as an uncomfortable experience for the patient, biopsies are generally taken with no analgesia or anaesthesia, and considered safe as an outpatient procedure [3].

More patients are undergoing biopsy on the basis of screen-detected PSA values and often repeat biopsies are indicated despite initial negative histology. The degree of discomfort and acceptability of repeat procedures will become a particularly important issue in this group of patients. In a previous audit of our practice, we found that men complained of significant discomfort during and after biopsy, and 22% of respondents requested sedation if they had to undergo the procedure again [4]. On the basis of this finding we changed our practice and offered sedation to patients undergoing TRUS and biopsy. We conducted a retrospective postal questionnaire study, and found significantly less discomfort and better patient satisfaction in the sedated group than in men biopsied with no sedation [5]. Given the limitations of a retrospective study, we then conducted a prospective study to validate these findings.

Patients and methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References
  9. Authors

A retrospective postal questionnaire (Fig. 1) was sent to 100 patients who had undergone TRUS and biopsy between January 1998 and August 1998. At this time patients were either sedated or not, depending on the consultants' preference. A prepaid envelope was included to return the responses. A prospective study was then conducted in 130 patients undergoing TRUS and biopsy between January 1999 and January 2000. Patients were fully counselled and provided informed consent before the procedure, and were assessed by a consultant anaesthetist for suitability for sedation. Intravenous propofol (1–1.5 mg/kg, Diprivan, AstraZeneca UK) as an intravenous injection over 1–5 min was administered by an anaesthetist for patients receiving sedation; routine noninvasive monitoring was used. A 7 MHz Sonoline SL 250 sector scanner (Siemens AG, Erlangen, Germany) was used to image the prostate and with the patient in the left lateral decubitus position, sextant biopsies were taken with a spring-loaded biopsy gun (Pro-Mag 2.2, Manan, Israel) and an 18G Trucut needle (Bard Urological, UK). Further biopsies were taken of any ultrasonographic or palpable abnormalities as appropriate. All procedures were undertaken by either a consultant urologist or a higher surgical trainee under supervision. Routine antibiotic prophylaxis involved intravenous gentamicin (80 mg) at the start of the procedure, followed by oral ciprofloxacin (500 mg twice daily for 3 days). After completing the biopsies, metronidazole (1 g) and a diclofenac suppository (100 mg slow-release) were administered rectally.

image

Figure 1. The TRUS and prostatic biopsy symptom questionnaire.

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In the prospective study patients were discharged home 2 h after the procedure and given a questionnaire. An identical questionnaire was used as in the retrospective study. Patients were requested to complete this just before their follow-up clinic appointment (≈2 weeks later). The levels of patient discomfort and overall satisfaction with the procedure were assessed using visual analogue scales (VAS) with direct questions about common side-effects (Fig. 1). The VAS gave a range of potential scores (0–10) with a score of 0 reflecting least discomfort and greatest satisfaction. The data were analysed using the Mann–Whitney U-test, with P < 0.05 considered to indicate statistically significant differences.

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References
  9. Authors

Of 100 patients sent a retrospective questionnaire, replies were received from 81, of whom 47 had received sedation and 34 not; the mean (95% CI) pain scores were 2.07 (1.5–2.65) and 3.5 (2.4–4.5), respectively (P = 0.01). Similarly, the difference in patient acceptability of the procedure was also significant, with scores of 1.3 (0.8–1.7) and 3.1 (1.8–4.4), respectively (P = 0.03). Complications reported after the procedure were similar in both groups.

In the subsequent prospective study, 130 questionnaires were distributed and replies were received from 110 (84%) patients. The mean pain score for this group was 1.5 (1.2–1.8) and the patient satisfaction score 0.9 (0.65–1.2) (both P < 0.001), maintaining the benefits seen in the initial evaluation. Haematuria was reported in 46% and haematospermia in 36%; low-grade fever occurred in 11%, testicular discomfort in 7% and admission was required in 4% (Table 1). The cause for the admission was sepsis requiring inpatient antibiotic treatment, and all patients were treated and discharged within 72 h.

Table 1.  Complications (%) of TRUS and biopsy
ComplicationNo sedationSedationSedation (prospective study)
Haematuria283246
Haemospermia161536
UTI1 9 2
Fever2 311
Painful testes5 3 7
Rectal bleeding9 615
Rectal pain9 412
Admission0.4 2 4

Discussion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References
  9. Authors

The morbidity and complications of TRUS and biopsy are well established [3,6]. Sepsis is the most serious potential complication and prophylactic antibiotic policies have successfully reduced the risks [7]. The incidence of more minor but common complications is also well documented, and patients can be counselled and advised of the potential sequelae of undergoing biopsy. After TRUS, haematuria rates are 12.5–58.4%, with haemospermia in 5–45.5% of patients [3,8–10]. In a large screening study in Northern Europe, haematuria was reported in 23.6% and haemospermia in 45.3% [2]. The present results show that the retrospective reporting of complications was noticeably lower than when collected prospectively. This undoubtedly reflects one of the drawbacks of retrospective data collection. In general, the complication rates reported were in line with reported data, although it is interesting that admission rates after sedation were higher (4% vs 0.4%); in large series they are typically < 1% [2]. None of the admissions were for complications of the sedation. There is no obvious explanation for this, although it is possible that sedation allows a more extensive and perhaps thorough sampling of the prostate; however, we have no data to support this.

The level of patient tolerance and acceptability of a procedure is harder to quantify and is by necessity subjective; VAS are a useful tool in this respect [11]. Irani et al.[12] used VAS in assessing 81 patients undergoing TRUS biopsy and found a mean value of 3, which compares closely to the value of 3.5 found in the present retrospective analysis. In addition five of 34 (14%) patients reported a VAS of > 5 and 15 (44%) would request sedation or anaesthesia if a repeat procedure was needed. By using sedation the level of pain decreased to 1.5 on the VAS in the 110 patients prospectively assessed, and patient satisfaction improved to 0.9; only three of the 110 (2.7%) patients reported a pain score of > 5.

Studies by Collins et al.[3] and Clements et al.[6] reported that 22% and 30% of patients, respectively, found the procedure painful. Similar levels of pain were reported by Crundwell et al.[13] using VAS at 1 week after biopsy, with 24% finding the experience moderately to extremely painful. These reports indicate a level of pain and discomfort that might be considered unsatisfactory in other diagnostic procedures. It is perhaps not surprising that in one series 19% of patients would refuse a further biopsy without some form of anaesthesia [12]. In an interesting study, Zisman et al.[14] assessed the effect of prostatic biopsy on patient well-being, particularly pain and anxiety. They found that 20% of patients considered the pain associated with biopsy to be severe in the first 24 h after the procedure and that significant preoperative anxiety was reported in 64%. The younger the patient, the greater the pain and anxiety experienced.

Alternative methods of administering local anaesthetic may be of benefit, although it is unclear which sensory pathways are involved. The use of rectally administered lignocaine gel has been assessed in a double-blind placebo-controlled trial by Desgrandchamps et al.[15]. They used a verbal rating scale to assess the severity of discomfort immediately after the procedure and reported no significant difference between the groups. Moderate to severe pain was experienced by 12.5% of patients administered lidocaine 15 min before the procedure and by 11% of those given gel; < 10% in both groups had no pain. The injection of local anaesthetic before biopsy has also been investigated [16]. In a randomized trial, a 10-mL injection of lignocaine into the neurovascular bundle before biopsy significantly reduced pain at the time of biopsy. Interestingly, this effect was lost at 1 week. There was no difference in complications [17].

The present propofol injection was administered by an anaesthetist and routine monitoring used; although it is not mandatory to have an anaesthetist present, it is preferable. The use of propofol is associated with rapid recovery and a minimal ‘hangover’ period, but after its use the patient must have an escort to return home and be advised not to drive for at least 24 h. All procedures were undertaken on the routine day-theatre list and obviously the use of anaesthetic staff has cost implications. Any cost calculation must be balanced against the improved level of the overall experience for the patient.

In conclusion, the present results show that sedation significantly reduced patient discomfort and make TRUS-guided prostatic biopsy a more satisfactory experience for the patient. Both the psychological and physical harm that prostatic biopsies cause a patient may be underestimated; sedation may usefully reduce this stress. Reducing the discomfort of TRUS biopsy is particularly important for the proportion of men who need repeated prostatic biopsies, either because of technical inadequacies at the time or because of alterations in the clinical picture with time.

Acknowledgements

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References
  9. Authors

We thank our anaesthetic colleagues for their help in conducting this study, and Anne Cowley for her invaluable secretarial skills.

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References
  9. Authors
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Authors

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References
  9. Authors

J.L. Peters, FRCS(Urol), Specialist Registrar, currently at Middlesex Hospital, London.

A.C. Thompson, MS, FRCS(Urol), Senior Registrar, currently Consultant Urologist, Royal Marsden and Kingston Hospitals, London.

T.A. McNicholas, FEBU, FRCS, Consultant Urologist.

J.E.W. Hines, FRCS(Urol), Senior Registrar, currently Consultant Urologist, Whipps Cross Hospital, London.

D.C. Hanbury, MS, FRCS(Urol), Consultant Urologist.

G.B. Boustead, MMed, FCS(SA)Urol, Consultant Urologist.