The National Institute for Clinical Excellence is examining endoscopic laser foraminoplasty 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 endoscopic laser foraminoplasty.

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

Please note the following:

• this is a consultation document issued some time ago
• it is not the Institute's guidance
• it is not a statement of the current or previous position of the Institute.
• nothing in it should be regarded as definite
• the content of the document has changed significantly following comments received during consultation
• the Institute has now published guidance on this procedure, which supersedes this document.

Readers should refer to the Institute's guidance on the endoscopic laser foraminoplasty.

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 recommendation 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: 27 May 2003
Target date for publication of guidance: 24 September 2003

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

Provisional recommendation

Current evidence of the safety and efficacy of endoscopic laser foraminoplasty 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 endoscopic laser foraminoplasty 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, but recommends its use is confined to randomised controlled trials.

The procedure

Indications

Outline of the procedure

This endoscope-assisted laser technique is used to widen the lumbar exit foramina for nerves from the lumbar spine. A laser is inserted to ablate portions of the intervertebral disc that have protruded and caused narrowing of the foramina.

Efficacy

The research undertaken to date has all been led by a single clinician. The studies were not clear about the indications for the procedure, but they generally indicated decreased pain after the procedure.

Specialist Advisors believed that the efficacy of this procedure is unproven.

Safety

Please note that important changes to the consultation document were made by the Advisory Committee in light of consultation responses. No part of this document, including this section, should be take as the view of NICE. The views of Specialist Advisors are their own and not necessarily those of NICE.

The research undertaken to date has all been led by a single clinician. The rates of reported complications were low, with discitis and neurological deficit being the most common (both with incidence below 1%).

Specialist Advisors were concerned about the safety of this procedure. They reported a number of serious complications, including paraplegia and major infections.

Other comments

The Interventional Procedures Advisory Committee noted that the basis on which to select patients for laser foraminoplasty is not clear.