Understanding NICE guidance Information for people who use NHS services
Treatment of prostate cancer with laparoscopic radical prostatectomy NICE ‘interventional procedures guidance’ advises the NHS on when and how new surgical procedures or procedures that use electromagnetic radiation (such as X-rays, lasers and gamma rays) can be used.
This leaflet is about when and how laparoscopic radical prostatectomy can be used to treat men with localised prostate cancer in the NHS in England, Wales, Scotland and Northern Ireland. It explains guidance (advice) from NICE (the National Institute for Health and Clinical Excellence). NICE has produced this guidance because the procedure is quite new. This means that there is not a lot of information yet about how well it works, how safe it is and which patients will benefit most from it. This leaflet is written to help men who have been offered this procedure to decide whether to agree (consent) to it or not. It does not describe prostate cancer or the procedure in detail – a member of your healthcare team should also give you full information and advice about these. The leaflet includes some questions you may want to ask your doctor to help you reach a decision. Some sources of further information and support are on the back page. Interventional procedures guidance makes recommendations on the safety of a procedure and how well it works. The guidance does not cover whether the NHS should fund a procedure. Decisions about funding are taken by local NHS bodies (primary care trusts and hospital trusts) after considering how well the procedure works and whether it represents value for money for the NHS.
Information about NICE interventional procedure guidance 193 Issue date: November 2006
What has NICE said? This procedure can be offered routinely as a treatment option for men with localised prostate cancer provided that doctors are sure that: • the patient understands what is involved and agrees to the treatment, and • the results of the procedure are monitored. All alternative treatments should be discussed with the patient and the patient should be given this leaflet. Surgeons should have specialised training before carrying out this procedure.
This procedure may not be the only possible treatment for localised prostate cancer. Your healthcare team should talk to you about whether it is suitable for you and about any other treatment options available.
Laparoscopic radical prostatectomy The procedure is not described in detail here – please talk to your specialist for a full description. In laparoscopic radical prostatectomy, the whole of the prostate gland and some surrounding healthy tissue is removed using specialised instruments that are inserted through small cuts in the abdomen. (This is called ‘keyhole’ surgery.) The surgeon may also use robots to help with the surgery. This type of procedure is only done if the cancer has not spread beyond the prostate gland.
Information about NICENICE interventional procedure guidance 193 xxx 2 Information about interventional procedure guidance
What does this mean for me? NICE has said that this procedure is safe enough and works well enough for use in the NHS. If your doctor thinks laparoscopic radical prostatectomy is a suitable treatment option for you, he or she should still make sure you understand the benefits and risks before asking you to agree to it.
You may want to ask the questions below • What does the procedure involve?
You might decide to have this procedure, to have a different procedure, or not to have a procedure at all.
• What are the benefits I might get? • How good are my chances of getting those benefits? Could having the procedure make me feel worse? • Are there alternative procedures? • What are the risks of the procedure? • Are the risks minor or serious? How likely are they to happen? • What care will I need after the operation? • What happens if something goes wrong? • What may happen if I don’t have the procedure?
Summary of possible benefits and risks Some of the benefits and risks seen in the studies considered by NICE are briefly described below. NICE looked at six studies on this procedure.
How well does the procedure work? The number of men who developed further cancer after different methods of laparoscopic surgery was studied. In one study at 10 months after laparoscopic surgery, 81% of men had no further cancer. In another study at 30 months after laparoscopic surgery, 99% of men had no further cancer. The rates reported are similar to those reported for traditional open surgery. The healthy tissue that is removed with the cancer is examined after surgery to check that all of the cancer has been removed. Eight studies of laparoscopic surgery and open surgery showed that the rate of not removing all of the cancer was similar. Two studies showed that this occurred more often with open surgery, and one study showed that it occurred more often with laparoscopic surgery. Out of just over 1400 men treated with laparoscopic surgery, the cancer was not removed fully in one in every five. Out of just over 22,000 men treated with open surgery, nearly one in every four had some cancer that was not removed.
Information about interventional procedure guidance Information about NICENICE interventional procedure guidance xxx 193 3
The expert advisers said that laparoscopic surgery may increase the chance of completely removing the cancer. They also said it offers an improved chance of the cancer not returning.
Risks and possible problems Most studies showed that rates of bladder problems were similar after laparoscopic or open surgery. Patients lost less blood during laparoscopic surgery than during open surgery. In two studies, 53–62% of men who were able to achieve an erection before laparascopic surgery were still able to afterwards. In another study, 80% of men were still able to achieve an erection after surgery. Three other studies reported that the effect of surgery on the ability to achieve an erection was similar with open and laparoscopic surgery. The expert advisors said that the adverse effects of laparoscopic surgery were similar to those that occur with open surgery. Other risks that may occur are release of gas bubbles into the circulation, damage to the intestine, and bleeding.
More information about prostate cancer NHS Direct online (www.nhsdirect.nhs.uk) may also be a good starting point for finding out more. Your local Patient Advice and Liaison Service (PALS) may also be able to give you further advice and support.
About NICE NICE produces guidance (advice) for the NHS about preventing, diagnosing and treating different medical conditions. The guidance is written by independent experts including healthcare professionals and people representing patients and carers. They consider how well an interventional procedure works and how safe it is, and ask the opinions of expert advisers. Staff working in the NHS are expected to follow this guidance. To find out more about NICE, its work and how it reaches decisions, see www.nice.org.uk/aboutguidance This leaflet and the full guidance aimed at healthcare professionals are available at www.nice.org.uk/IPG193 You can order printed copies of this leaflet from the NHS Response Line (phone 0870 1555 455 and quote reference N1137).
National Institute for Health and Clinical Excellence MidCity Place, 71 High Holborn, London WC1V 6NA; www.nice.org.uk © National Institute for Health and Clinical Excellence, November 2006. All rights reserved. This material may be freely reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the express written permission of the Institute.
ISBN 1-84629-303-0 N1137 1P Nov 06