The National Institute for Clinical Excellence is examining circular stapled haemorrhoidectomy 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 circular stapled haemorrhoidectomy.

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 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: 2 September 2003

Target date for publication of guidance: January 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 circular stapled haemorrhoidectomy appears adequate to support the use of the procedure, provided that normal arrangements are in place for consent, audit and clinical governance.

Clinicians wishing to learn circular stapled haemorrhoidectomy should be trained, mentored and monitored, as described in the Association of Coloproctology's consensus document on the procedure (see the Association's website: www.acpgbi.org.uk).

Circular stapled haemorrhoidectomy is used to treat internal haemorrhoids, which develop when cushions of vascular tissue in the anus undergo pathological change. Haemorrhoids may cause bleeding, faecal soiling, itching and occasionally pain.

Circular stapled rectal haemorrhoidectomy reduces the size of internal haemorrhoids by interrupting their blood supply, reducing the available rectal mucosa with the potential to prolapse. Whereas conventional surgical haemorrhoidectomy involves excision of haemorrhoidal tissue, anoderm and perianal skin, stapled haemorrhoidectomy simply excises an annulus of rectal mucosa above the haemorrhoids.

The studies suggested that patients had less pain and returned to normal activity more quickly with stapled haemorrhoidectomy than with conventional haemorrhoidectomy. One randomised controlled trial with 84 patients reported an average return to work of 6 days following the circular stapled technique, compared with 15 days following conventional surgery. For more details refer to the Overview (see Appendix A).

The Specialist Advisors stated that circular stapled haemorrhoidectomy was relatively new, but that an increasing number of surgeons were using this approach for the treatment of haemorrhoids. The Advisors considered stapled haemorrhoidectomy to be as effective as the surgical alternative. They noted that there were limited long-term data available and that the durability of the procedure was therefore unclear.

The Specialist Advisors also noted that there was a requirement for training, and suggested a learning curve of 10-12 cases.

The studies suggested a lower overall postoperative complication rate with circular stapled haemorrhoidectomy than with conventional haemorrhoidectomy. A systematic review published in 2001 indicated a significant reduction in the risk of bleeding at 2 weeks postoperatively. For more details refer to the Overview (see Appendix A).

Adverse events were said to centre upon the possibility of a full thickness excision to the rectal wall, with the potential for injury to the internal anal sphincter. In addition, stretching of the anal sphincter by the stapler head may, in theory, cause injury.

The Specialist Advisors suggested that most of the safety concerns were theoretical and that many of these concerns were not supported by trials that have been published.

The Advisory Committee noted that long-term data were lacking and that the Association of Coloproctology of Great Britain and Ireland is undertaking audit on this procedure. Surgeons doing this procedure are strongly encouraged to include patients in this audit.

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

• Interventional Procedure Overview of Circular Stapled Haemorrhoidectomy, November 2002