Haemorrhoidal artery ligation - Interventional Procedures Consultation Document
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Haemorrhoidal artery ligation
Haemorrhoids (also known as piles) are enlarged blood vessels in or around the lower part of the bowel. They can cause itching, bleeding or pain, and may protrude outside the anus.
This procedure is carried out on an area of the lower part of the bowel that is relatively less sensitive to pain. Blood vessels are stitched to reduce the blood supply to the haemorrhoids, which relieves symptoms of bleeding and discomfort, and can help them to shrink. If they are large, the tissue overlying the haemorrhoids may also be folded up and stitched. No tissue removal is required for this procedure.
The National Institute for Health and Clinical Excellence (NICE) is examining haemorrhoidal artery ligation and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about haemorrhoidal artery ligation.
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 provisional recommendations
- the identification of factual inaccuracies
- additional relevant evidence, with bibliographic references where possible.
Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.
The process that NICE 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- The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.
For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).
NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.
Closing date for comments: 27 January 2010
Target date for publication of guidance: April 2010
1 Provisional recommendations
1.1 Current evidence on haemorrhoidal arterial ligation shows that this procedure is an efficacious alternative to conventional haemorrhoidectomy or stapled haemorrhoidopexy in the short and medium term, and that there are no major safety concerns. Therefore this procedure may be used provided that normal arrangements are in place for clinical governance, consent and audit.
2 The procedure
2.1 Indications and current treatments
2.1.1 Haemorrhoids (piles) occur when the vascular anal cushions become enlarged. They may cause symptoms of bleeding, itching or discomfort (Grade I) and, if large, may prolapse out of the rectum. Haemorrhoids that prolapse may reduce (return into the anal canal) spontaneously after defaecation (Grade II); they may need to be reduced digitally (Grade III); or they may not be reducible, remaining continually prolapsed (Grade IV).
2.1.2 Grade I or II haemorrhoids may be treated by diet modification and topical applications. Interventional treatments include rubber band ligation and sclerosant injections. Treatments for Grade III and IV haemorrhoids include surgical excision of the haemorrhoids (haemorrhoidectomy) or ‘non-excisional’ stapled haemorrhoidopexy.
2.2 Outline of the procedure
2.2.1 Haemorrhoidal arterial ligation reduces the blood flow to haemorrhoids, with the aim of reducing symptoms of discomfort and bleeding. It also aims to achieve some shrinkage of haemorrhoids but adjunctive treatment is required for large prolapsing haemorrhoids.
2.2.2 The procedure is usually performed with the patient under general anaesthesia, and is usually carried out after an enema. Using a proctoscope, the haemorrhoidal arteries are ligated with sutures (above the dentate line) to remove the flow of blood to the haemorrhoids. A Doppler probe may be used to help locate the haemorrhoidal arteries. For larger prolapsing haemorrhoids, an adjunctive mucosal plication procedure is done. The prolapsing mucosa is plicated up to the level of the dentate line where it is fixed by ligation of the plicating sutures (haemorrhoidopexy).
|Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP803overview.|
2.3.1 In a systematic review of 17 studies with a total of 1996 patients, a subset of 6 studies with follow-up of 1 year or more (850 patients treated by haemorrhoidal arterial ligation) reported bleeding, pain on defaecation and prolapse in 10% (49/507), 9% (18/206) and 11% (46/427) of patients respectively. A subset of 9 studies with a follow-up of less than 1 year (855 patients treated by haemorrhoidal arterial ligation) reported bleeding, pain on defaecation and prolapse in 6% (40/638), 4% (35/917) and 8% (50/638) of patients respectively (all denominators as reported in the systematic review). The proportion of patients with preoperative bleeding, pain and prolapse ranged from 45% to 100%, 12% to 83% and 12% to 100% respectively across the studies.
2.3.2 An RCT of 41 patients treated by haemorrhoidal arterial ligation or stapled haemorrhoidopexy reported resolution of symptoms in 78% (18/23) and 83% (15/18) patients respectively (p = 0.65) at 6-week follow-up.
2.3.3 A case series of 616 patients treated by haemorrhoidal arterial ligation without Doppler guidance reported symptom resolution at 4-week follow-up in 96%, 98% and 96% of patients who had presented with bleeding, prolapse and pain on defaecation respectively (absolute figures not stated). A case series of 330 patients reported resolution of symptoms at a mean follow-up of 46 months in 93% (132/142) of patients who presented with bleeding and 92% (110/119) of patients who presented with prolapse (80 and 73 patients respectively were lost to follow-up; reason not stated). The case series of 616 patients reported a mean patient satisfaction score of 8.2 on a 10-point VAS (10 most satisfied) among 523 patients at 1-year follow-up (reason for loss to follow-up not stated).
2.3.4 The Specialist Advisers listed key efficacy outcomes as less postoperative pain than other treatments, resolution of haemorrhoids and relief of symptoms such as bleeding, prolapse, swelling, pain, soreness and itching in the short and long term.
2.4.1 Postoperative haemorrhage was reported in 3 patients out of 1996 treated by haemorrhoidal artery ligation, in the systematic review (2 required blood transfusion and 1 developed coagulopathy, not otherwise described). Bleeding requiring re-admission was reported in 4 patients in the case series of 616 patients (timing of events not stated). Immediate and delayed bleeding was reported in 4 and 3 patients respectively in the case series of 330 patients (1 case of immediate bleeding was due to laceration of a rectal polyp; 1 case of delayed bleeding required a further operation to stop the bleeding; no further details provided). Submucosal haematoma was reported in 1% (4/330) of patients in the case series of 330 patients (not otherwise described).
2.4.2 Postoperative haemorrhoid thrombosis was reported in 18 and 5 patients in the case series of 507 and 330 patients respectively (follow-up not stated). In a case series of 100 patients, thrombosis of residual haemorrhoids was reported in 3 patients at 4, 7 and 17-month follow-up (patients had grade III haemorrhoids; 2 treated by thrombectomy, 1 treated by haemorrhoidectomy). ‘Perianal thrombosis’ (not otherwise described) was reported in 12 patients in the case series of 616 patients (not otherwise described).
2.4.3 Postoperative fistula formation was reported in 1 patient in the case series of 507 patients (1-year follow-up).
2.4.4 Postoperative fissure was reported in 11 and 2 patients in the case series of 507 and 330 patients respectively (not otherwise described). Acute fissure (successfully managed by conservative treatment) was reported in 3 patients at 9, 10 and 15-day follow-up and anal fissure was reported in 2 patients at 8- and 11-month follow-up in the case series of 100 patients (not otherwise described).
2.4.5 The RCT of 41 patients treated by haemorrhoidal ligation or stapled haemorrhoidopexy reported postoperative pain on a VAS (range not defined) as 1.6 and 3.2 respectively at 7-day follow-up (p < 0.001) and 0.2 and 1.0 respectively at 21-day follow-up (p = 0.06).
2.4.6 The Specialist Advisers considered theoretical adverse events to include infection, rectal perforation, pelvic abscess, anal stenosis, acute and chronic pain and faecal incontinence.
3 Further information
3.1 For related NICE guidance see www.nice.org.uk.
Chairman, Interventional Procedures Advisory Committee
Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.
It is the responsibility of consultees to accurately cite academic work in order that they can be validated.
This page was last updated: 21 May 2010