Laparoscopic radical prostatectomy (review) (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Laparoscopic radical prostatectomy (review)

Prostate cancer is a common cancer in men. Laparoscopic radical prostatectomy is a type of surgery in which the prostate (and other tissues) is removed without the need for large incisions into the body. Robotic arms controlled by a surgeon can be used to assist with the operation.


The National Institute for Health and Clinical Excellence is examining laparoscopic radical prostatectomy and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about laparoscopic radical prostatectomy.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

  • comments on the preliminary recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

  • The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 25 July 2006
Target date for publication of guidance: November 2006


Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.


1 Provisional recommendations
1.1

Current evidence on the safety and efficacy of laparoscopic radical prostatectomy appears adequate to support the use of this procedure provided that normal arrangements are in place for consent, audit and clinical governance.

1.2

Clinicians should ensure that men understand all the alternative treatment options. Use of the Institute’s Information for the public is recommended (available from www.nice.org.uk/IPGXXXpublicinfo).

1.3 Clinicians undertaking laparoscopic radical prostatectomy require specialist training. The British Association of Urological Surgeons has produced training standards.

 

2 The procedure
2.1 Indications
2.1.1 Laparoscopic radical prostatectomy is indicated for localised prostate cancer with no evidence of spread beyond the prostate or of distant metastases.
2.1.2 Alternative treatment options include active monitoring (sometimes called watchful waiting), open radical prostatectomy, external beam radiotherapy, low-dose brachytherapy, combined external beam radiotherapy with high-dose brachytherapy, high-impact frequency ultrasound therapy, and cryotherapy.

 

2.2 Outline of the procedure
2.2.1 2.2.1 The procedure involves the insertion of a laparoscope and trocars through small incisions in the abdominal wall. The approach can be either transperitoneal or extraperitoneal. The prostate, adjacent tissue and lymph nodes are dissected and removed, and the urethra, which is cut during the procedure, is reconnected. Lymph nodes can be removed during the procedure for histological examination before removing the prostate. Robotically assisted laparoscopic prostatectomy is a development of this procedure and may allow greater precision in the manipulation of instruments used for the resection.

 

2.3 Efficacy
2.3.1

In a systematic review of non-randomised controlled studies, biochemically assessed recurrence-free survival ranged between 84% (36 months’ follow-up) and 99% (30 months) following transperitoneal laparoscopic radical prostatectomy, between 81% (10 months) and 91% (12 months) following extraperitoneal laparoscopic radical prostatectomy, and between 92% (8 months) and 95% (3 months) following robotically assisted laparoscopic radical prostatectomy. None of these outcomes was significantly different from those observed in men undergoing open radical prostatectomy.

2.3.2 In a systematic review of non-randomised controlled trials, 8 of 11 studies comparing either the transperitoneal or extraperitoneal laparoscopic approach with open radical prostatectomy reported no significant difference in rates of tumour-positive resection margins between the two procedures. The other three studies in the review reported significant differences: 50% (transperitoneal) versus 29% (open) (p = 0.03), 14% (transperitoneal) versus 26% (open) (p = 0.02) and 26% (extraperitoneal) versus 40% (open) (p = 0.0001). Pooled data from six case series and two databases indicated a tumour-positive resection margin in 20% of 1439 men treated with laparoscopic radical prostatectomy (any approach) and 24% of 22,164 men treated with open radical prostatectomy. For more details, refer to the sources of evidence (see appendix).
2.3.3 The Specialist Advisors stated that the benefits of laparoscopic radical prostatectomy may include low positive surgical margin rates, and good biochemically assessed recurrence-free survival.

 

2.4 Safety
2.4.1 In a systematic review of 10 non-randomised controlled studies, five studies reported no significant differences in rates of post-operative urinary continence between the different methods of radical prostatectomy. One study reported a significant difference that favoured laparoscopic surgery, and four did not report whether differences in continence rates were statistically significant.
2.4.2 In the studies that reported on erectile dysfunction as a complication, potency was retained in 53–62% of men who were potent at baseline. Preserved potency rates of 82% were reported in men treated with robotically assisted laparoscopic radical prostatectomy. In a systematic review of non-randomised controlled studies, three studies reported that there was no significant difference in potency rates following laparoscopic or open radical prostatectomy groups. For more details, refer to the sources of evidence (see appendix).
2.4.3 The Specialist Advisors stated that reported adverse events with laparoscopic radical prostatectomy were similar to those for open procedures. Additional theoretical complications include gas embolus, bowel damage and haemorrhage.
 

 

3 Further information
3.1 The Institute has issued interventional procedure guidance on high-intensity focused ultrasound for prostate cancer (www.nice.org.uk/IPG118guidance), cryotherapy for recurrent prostate cancer (www.nice.org.uk/IPG119guidance), cryotherapy as a primary treatment for prostate cancer (www.nice.org.uk/IPG145guidance) and low dose rate brachytherapy (www.nice.org.uk/IPG132guidance) and high dose rate brachytherapy in combination with external-beam radiotherapy (www.nice.org.uk/IPG174guidance) for localised prostate cancer.
3.2 The Institute is also developing a clinical guideline on the diagnosis and treatment of prostate cancer (see www.nice.org.uk for more information).

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
July 2006

Appendix: Sources of evidence

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

  • Interventional procedure overview of laparoscopic radical prostatectomy, April 2006

Available from: http://www.nice.org.uk/page.aspx?o=ip039overview2

This page was last updated: 05 February 2011