The National Institute for Health and Clinical Excellence is examining laparoscopic helium plasma coagulation for the treatment of endometriosis 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 helium plasma coagulation for endometriosis.

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 recommendations
• 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The Advisory Committee will then prepare draft guidance which will be the basis for the Institute’s guidance on the use of the procedure in the NHS in England, Wales and Scotland.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: 28 February 2006

Target date for publication of guidance: May 2006

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

Current evidence suggests there are no major safety concerns associated with laparoscopic helium plasma coagulation for the treatment of endometriosis. However, evidence on efficacy does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research .

Clinicians wishing to undertake laparoscopic helium plasma coagulation for the treatment of endometriosis should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainty about the efficacy of the procedure and provide them with clear written information. In addition, use of the Institute’s Information for the public is recommended (available from www.nice.org.uk/IPGXXXpublicinfo).
• Audit and review clinical outcomes of all patients having laparoscopic helium plasma coagulation for the treatment of endometriosis.

Clinicians undertaking this procedure should have adequate training before performing the technique. The British Society for Gynaecological Endoscopy has produced standards for training (www.bsge.net).

Publication of randomised controlled trials on the efficacy of this procedure will be useful. The Institute may review the procedure upon publication of further evidence.

Women with endometriosis have deposits of endometrial tissue (which is normally confined to the lining of the uterus) outside the uterus. Many women are asymptomatic, but others may experience pelvic pain, dyspareunia, dysmenorrhoea or infertility. Endometriosis is a dynamic benign disease and the majority of women will not improve if untreated.

Most women with endometriosis can be treated with analgesics and hormones. Women whose endometriosis does not respond may be offered minimally invasive surgery to excise or vaporise the endometrial deposits, most commonly by electrocautery or laser through a laparoscope. Women with very severe symptoms may be offered more radical treatment involving hysterectomy and removal of the ovaries.

Laparoscopic helium plasma coagulation of endometriosis is a minimally invasive procedure used to vaporise endometrial deposits. A laparoscope is used to direct an ionised beam of helium gas at endometrial deposits to destroy them.

The method of evaluation of symptoms following the procedure varied between studies making comparison difficult. Across three series symptomatic relief was achieved in 49% (39/79), 72% (179/250), and 81% (17/21) of patients at 3 months follow-up. In another case series, continuing symptoms were reported in 38% (5/13) of patients at 14 months follow-up.

Only one case series of 50 women, including 9 who presented with infertility and 15 who were both symptomatic and infertile, reported fertility outcomes: 44% (4/9) of the solely infertile group and 20% (3/15) of the women who were also symptomatic had conceived within 6 months of the procedure.

In one case series none of 250 procedures had to be converted to open surgery, and there were no readmissions after 3 months, whereas a repeat procedure was required in 16% (5/31) of patients in another case series in which the mean period to return to normal daily activities was 12 days. There was no long-term follow-up of patients for longer than 6 months in published case series. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors noted that the procedure may cause less lateral burning than the diathermy technique, and may allow patients to be treated on a day case basis.

Three series recorded no side effects or complications related to the procedure in a total of 130 women. After 3 months of follow-up of 250 cases, one case series reported no major postoperative complications and no surgical complications. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors noted that theoretical adverse events might include damage to normal tissue (common to other energy sources), bowel injury, haemorrhage, infection and, potentially, helium embolisation.

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

Interventional procedure overviewofl aparoscopic helium plasma coagulation for endometriosis, November 2005

Available from: www.nice.org.uk/ip167overview