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

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendations 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 Procedure 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: 28 October 2003

Target date for publication of guidance: April 2004

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 total hysterectomy 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 total hysterectomy 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 should provide them with clear written information. Use of the Institute's Information for the Public is recommended. Clinicians should ensure 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.

Clinicians undertaking this procedure should undergo training as recommended by the report of the Royal College of Obstetricians and Gynaecologists Working Party on Training in Endoscopic Surgery www.rcog.org.uk

Hysterectomy is used to treat a wide range of gynaecological conditions, including malignancy, and benign conditions such as fibroids, heavy periods and pelvic pain.

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

Conventional hysterectomy involves the surgeon removing the uterus through an abdominal incision or through the vagina. Laparoscopic hysterectomy involves removing the uterus, and sometimes the fallopian tubes and ovaries, through smaller abdominal incisions. The technique is distinct from laparoscope assisted vaginal hysterectomy, which combines transabdominal laparoscopy and vaginal hysterectomy.

These recommendations apply to laparoscopic total hysterectomy and not hand-assisted laparoscopic hysterectomy.

In two randomised controlled trials postoperative hospital stay was shorter for women undergoing laparoscopic hysterectomy (3 days) than for women undergoing abdominal hysterectomy (5 days). There was also some suggestion that mean blood loss was less with laparoscopic hysterectomy. However, efficacy outcomes in general were not well reported. Follow-up was short and randomisation and blinding were not described. For more details refer to the Overview (see Appendix).

Specialist Advisor opinion was divided between those who had no concerns regarding the efficacy of the procedure and those who remained uncertain. They commented that adequate training and equipment must be provided.

Few complications were reported in the studies. The most common complication was fever after the procedure. In a randomised controlled trial of 122 women, 60 of whom underwent laparoscopic hysterectomy, one conversion to laparotomy was necessary because of incidental bowel injury. For more details refer to the Overview (see Appendix).

Two of the Specialist Advisors noted that this procedure could result in damage to the ureter and bladder.

The evidence considered by the Interventional Procedures Advisory Committee is described in the following document.

• Interventional Procedure Overview of Laparoscopic Total Hysterectomy, November 2002

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