Interventional procedures consultation document - Radical laparoscopic hysterectomy

Untitled Document

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE

Interventional Procedures Consultation Document

51 - Radical laparoscopic hysterectomy

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


1 Provisional recommendations
1.1

Current evidence on the safety and efficacy of radical laparoscopic 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 radical laparoscopic 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 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 any further investigation at present.

1.2

The Interventional Procedures Advisory Committee noted that the thoroughness of lymph node excision is important, both diagnostically and prognostically, and that there is uncertainty about whether lymph node staging can be carried out adequately via a laparoscope.

1.3

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).



2 The procedure
2.1 Indications
2.1.1

Laparoscopic radical hysterectomy is a minimally invasive alternative to traditional radical hysterectomy, which is performed through an incision in the abdomen.

2.1.2

Laparoscopic radical hysterectomy can be used to treat stage I and stage IIA cervical cancer. Stage I cervical cancer is confined to the cervix. Stage IIA cervical cancer has spread to the top of the vagina, but not into the uterus.

2.2 Outline of the procedure
2.2.1

Radical hysterectomy involves surgical removal of the uterus, the supporting ligaments and the upper vagina, together with removal of the pelvic lymph nodes and sometimes the para-aortic lymph nodes.

2.3 Efficacy
2.3.1

The evidence relating to this procedure was based entirely on two case series. In the larger series involving 78 women, with a mean follow up of 67 months, there were eight cases of recurrence (10%). The estimated 5-year free interval after treatment was 89%. No recurrences were reported in the smaller case series involving 41 women. For more details refer to the overview (see below).

2.3.2

All Specialist Advisors thought that laparoscopic radical hysterectomy was not a new procedure but a variation on established practice. They noted that only a few gynaeocological oncologists, in a few specialised units, performed the procedure regularly, and that it required considerable laparoscopic expertise.

2.4 Safety
2.4.1

The larger case seriesreported a post-operative complication of rate of 9%, including one patient with a ureterovaginal fistula and two patients with pelvic lymphocysts. However this result should be interpreted with caution, given the limited data available. For more details refer to the overview (see below).

2.4.2

The Specialist Advisors considered that the potential complications associated with laparoscopic radical hysterectomy were similar to those associated with open radical hysterectomy, but the technical demands of laparoscopic radical hysterectomy increased the risks. They specifically reported instances of injury to the bowel, to vessels in the abdominal wall, and to the urinary tract. They also expressed concern about long-term survival following use of this procedure.

2.4.3

It was noted that there were no long-term data for this procedure, and a lack of data on comparisons between laparoscopic and open radical hysterectomy.



Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
July 2003

Appendix A: Overview considered by the Committee

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

  • Interventional Procedures Overview of Radical Laparoscopic Hysterectomy, April 2003
Available from: www.nice.org.uk/IP051overview