The National Institute for Clinical Excellence is examining laparoscopic hysterectomy 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 hysterectomy.

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 recommendation
• 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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.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: 23 November 2005

Target date for publication of guidance: February 2005

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

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. Use of the Institute's Information for the Public is recommended.
• Audit and review clinical outcomes of all patients having total laparoscopic hysterectomy

Hysterectomy is performed for a variety of benign conditions (such as fibroids, heavy periods and pelvic pain) that have not responded to medical treatment, and also for malignant conditions of the uterus.

A conventional hysterectomy involves removing the uterus through an abdominal incision or through the vagina.

A laparoscope is introduced through a small incision in the abdomen and two or three further small incisions are made in the lower abdomen to provide access for additional surgical instruments. A manipulator is placed in the uterus via the vagina. The remainder of the procedure varies according to the amount of surgery performed laparoscopically. In any of the procedures the cervix may be removed along with the uterus (total hysterectomy) or it can be left in situ (subtotal or supracervical hysterectomy).

All these techniques achieve removal of the uterus with relief of symptoms in properly selected patients. Comparative studies have therefore focused on hospital stay and quality-of-life outcome measures.

One randomised controlled trial of 876 women, comparing all forms of laparoscopic hysterectomy with abdominal hysterectomy, reported that the median length of hospital stay was 3 days after laparoscopic hysterectomy and 4 days after abdominal hysterectomy. Women treated with laparoscopic hysterectomy had a significantly better quality of life at 6 weeks after the procedure than women treated with abdominal hysterectomy (p < 0.001). There was no significant difference in the quality-of-life scores at 12 months. Although this study included all four laparoscopic techniques together, the majority of the procedures were laparoscopic-assisted vaginal hysterectomies and laparoscopic hysterectomies.

In one randomised controlled trial, 11% (65/584) of women treated by laparoscopic hysterectomy had at least one major complication, compared with 6% (18/292) of women treated by abdominal hysterectomy (p = 0.02). In another randomised controlled trial, comparing laparoscopic hysterectomy (n = 336) with vaginal hysterectomy (n = 168), around 10% of women in both groups had at least one major complication. The main complications in these two trials included haemorrhage in 5% (44/920) of patients, the need for a laparotomy in 3% (32/920) of patients, bladder injury in 2% (15/920) and damage to the ureter in less than 1% (6/920) of patients. Other complications included pulmonary embolism, bowel injury and haematoma. Both of these trials included all types of hysterectomy together but the majority of procedures were laparoscopic-assisted vaginal hysterectomies.

A non-randomised comparative study reported a mortality rate of 0.04% (1/2434) for all types of laparoscopic hysterectomy, 0.06% (1/1801) for vaginal hysterectomy and 0.02% (1/5875) for abdominal hysterectomy. This was not statistically significant. For more details, refer to the Sources of evidence (see Appendix).

The Committee noted there was less evidence about laparoscopic hysterectomy and laparoscopic supracervical hysterectomy than laparoscopic-assisted vaginal hysterectomy.

The following documents, which summarise the evidence, were considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

• Interventional procedure overview of laparoscopic hysterectomy, July 2004
• Interventional procedure overview of laparoscopic total hysterectomy, November 2002

Available from: www.nice.org.uk/ip055overview