The National Institute for Clinical Excellence is examining laparoscopic laser myomectomy and will publish guidance on its safety and efficacy to the NHS in England and Wales. 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 laser myomectomy.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendation made by the Advisory Committee.

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 the Final Interventional Procedures Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

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

Closing date for comments: 22 July 2003

Target date for publication of guidance: 24 December 2003

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

Current evidence on the safety and efficacy of laparoscopic laser myomectomy does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Clinicians wishing to undertake laparoscopic laser myomectomy should inform the clinical governance leads in their Trusts. They should ensure that patients offered it understand the uncertainty about the procedure's safety and efficacy and that appropriate arrangements are in place for audit or research. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present.

The Advisory Committee also noted that clinicians undertaking this procedure should undergo training as recommended by the Royal College of Obstetricians and Gynaecologists Working Party on Training in Endoscopic Surgery (www.rcog.org.uk).

Laparoscopic laser myomectomy is used to treat uterine fibroids, also known as uterine leiomyomas or uterine myomas. Fibroids are benign tumours of the uterine muscle. They are very common and may cause abnormal bleeding, pelvic pressure and pain, and reproductive problems.

Hysterectomy is the standard treatment for women with fibroids whose symptoms have not resolved with medical treatment.

Laparoscopic laser myomectomy involves the destruction of fibroids via a laparoscope passed through a small incision in the abdomen and then through the wall of the uterus. The fibroids are destroyed with a laser.

The evidence reviewed was of poor quality and did not clearly report efficacy outcomes, particularly outcomes relating to symptomatic relief. For more details refer to the overview (see below).

The Specialist Advisors noted that the indications for this treatment were unclear, which made it difficult to assess its efficacy. One Advisor noted that the procedure was suitable only for removing relatively small fibroids, which tend to be asymptomatic, and therefore questioned the clinical value of using this procedure.

The evidence reviewed was too limited to establish the safety of this procedure. For more details refer to the overview (see below).

The Specialist Advisors reported that the there are risks associated with the use of both laparoscopic and laser surgery, including bowel and urinary tract damage, and rupture of the uterine scar during subsequent labour.

Fibroids that are symptomatic are generally of a size and location that make treatment by laparoscopic laser myomectomy difficult.

The following source of evidence was considered by the Interventional Procedures Advisory Committee.

• Interventional Procedure Overview of Laparoscopic Laser Myomectomy, February 2003