NIHR Signal Treating low grade piles with a newer surgical technique leads to less recurrence than rubber band ligation

Published on 18 October 2016

The new technique, called haemorrhoidal artery ligation requires an anaesthetic. In this trial it led to fewer episodes of recurrence than a single rubber band ligation of piles. The rubber band ligation, which can be done in the clinic, is less painful in the short-term and cheaper. This means that the decision over which treatment to offer or accept is a “trade-off”.

Haemorrhoids affect a third of people in the UK, many of which can be managed using simple measures. For more serious cases, there are non-surgical and surgical options. This trial compared two methods to cut off the blood supply to the pile – either putting a rubber band around it in the clinic, or surgery to tie off the artery under anaesthetic in theatre.

The “trade-off” for patients will require an understanding of individual preferences. Those whose priority is to avoid pain or anaesthetic might prefer to stick with the older rubber band technique, accepting that it might need to be repeated. Those who want a more permanent solution in one visit to theatre might prefer ligation.

The newer technique of artery ligation is also more expensive than rubber band treatment, with a very low chance of being cost effective at the usual thresholds considered good value for the NHS. This will be important for commissioners. A better understanding of costs and patient preferences are likely to be the ultimate deciding factors when choosing between treatments.

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Why was this study needed?

Haemorrhoids are when the blood vessels and muscles in and around the anus (back passage) become swollen. Haemorrhoids are common, affecting around a third of people in the UK. About 5,000 haemorrhoidal artery ligations are already carried out each year in the UK.

The severity of haemorrhoids varies. Mild symptoms can include itching or passing some blood (usually bright red) after passing a stool. In such cases simple measures can be effective, including diet adjustments, for example increasing fibre content and drinking more water, or not straining when passing stools. For more severe cases, there are various treatments available to cut off the blood supply to the haemorrhoids, or sometimes the haemorrhoid may be removed in an operation.

This randomised controlled trial compared two methods of cutting off the blood supply: tying rubber bands around the base of the haemorrhoid (rubber band ligation), or a surgical procedure to stitch up the artery supplying it (haemorrhoidal artery ligation).

What did this study do?

This trial randomly assigned 372 people, from 17 UK hospitals, with moderate severity haemorrhoids to receive either rubber band ligation or haemorrhoidal artery ligation.

Rubber band ligation is a less invasive, outpatient procedure, but has a greater chance of haemorrhoids returning. Haemorrhoidal artery ligation has lower rates of recurrence but requires anaesthetic and has a risk of complications. The main outcome was recurrence of haemorrhoids, measured using patient self-report and GP and hospital records.

More people assigned to receive artery ligation dropped out of the trial before treatment was given (13%) compared to rubber banding ligation (4%). Also a higher proportion of people receiving banding had less serious haemorrhoids (65% vs. 57% for artery ligation), but the randomisation process ensured that patient characteristics didn’t influence treatment allocation.

What did it find?

  • Recurrence of haemorrhoids at 12 months (the primary outcome) was more common for people who had rubber band ligation (49%) than haemorrhoidal artery ligation (30%; adjusted odds ratio [aOR] 2.23, 95% confidence interval [CI] 1.42 to 3.51). A repeat procedure was needed by 32% who received banding compared with only 14% who received artery ligation.
  • Pain was significantly lower one day after the procedure with rubber band ligation: 3.4 on a 10-point scale compared with 4.6 after artery ligation (mean difference [MD] ‑1.2, 95% CI ‑1.8 to ‑0.5). At seven days rubber band ligation pain was still lower (1.6 vs. 3.1; MD ‑1.5, 95% CI ‑2.0 to ‑1.0). By three to six weeks there was no significant difference in pain (MD 0.2, 95% CI ‑0.2 to 0.7).
  • Serious adverse events occurred more frequently with haemorrhoidal artery ligation (12 people, 7%) than rubber band ligation (two people, 1%). Those in the artery ligation group included pain, bleeding, urine retention and infection.
  • Haemorrhoidal artery ligation had zero probability of being cost effective at a willingness-to-pay threshold of £20,000 per quality adjusted life year. Total costs were on average £1,027 higher for artery ligation than for rubber band ligation.

What does current guidance say on this issue?

2010 NICE guidance considers haemorrhoidal artery ligation to be a safe and effective alternative to conventional surgical options to remove the haemorrhoids (haemorrhoidectomy or stapled haemorrhoidopexy) in the short and medium term.

What are the implications?

Rubber band ligation led to a greater chance of haemorrhoid recurrence requiring further treatment but less short-term pain than haemorrhoidal artery ligation.

Rubber band ligation can be performed at an outpatient clinic, and does not require admission and a general anaesthetic. Therefore, the choice for patients is largely dependent on their preferences. It seems like the newer procedure is not a good buy for the NHS on the cost-effectiveness  grounds reported here. With a higher overall cost for the newer procedure it may not be favoured by commissioners either.

However, individual patient preferences and the severity of haemorrhoids are likely to be the main deciding factor when choosing between a non-surgical treatment such as banding or one of the surgical options.

Citation and Funding

Brown SR, Tiernan JP, Watson AJ, et al; HubBLe Study team. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. Lancet. 2016;388(10042):356-64.

This project was funded by the National Institute for Health Research (Health Technology Assessment programme) (project number 10/57/46).

Bibliography

NICE. Haemorrhoidal artery ligation. IPG342. London: National Institute for Health and Care Excellence; 2010.

NICE. Electrotherapy for the treatment of haemorrhoids. IPG525. London: National Institute for Health and Care Excellence; 2015.

NICE. Stapled haemorrhoidopexy for the treatment of haemorrhoids. TA128. London: National Institute for Health and Care Excellence; 2007.

NICE. Circular stapled haemorrhoidectomy. IPG34. London: National Institute for Health and Care Excellence; 2003.

Why was this study needed?

Haemorrhoids are when the blood vessels and muscles in and around the anus (back passage) become swollen. Haemorrhoids are common, affecting around a third of people in the UK. About 5,000 haemorrhoidal artery ligations are already carried out each year in the UK.

The severity of haemorrhoids varies. Mild symptoms can include itching or passing some blood (usually bright red) after passing a stool. In such cases simple measures can be effective, including diet adjustments, for example increasing fibre content and drinking more water, or not straining when passing stools. For more severe cases, there are various treatments available to cut off the blood supply to the haemorrhoids, or sometimes the haemorrhoid may be removed in an operation.

This randomised controlled trial compared two methods of cutting off the blood supply: tying rubber bands around the base of the haemorrhoid (rubber band ligation), or a surgical procedure to stitch up the artery supplying it (haemorrhoidal artery ligation).

What did this study do?

This trial randomly assigned 372 people, from 17 UK hospitals, with moderate severity haemorrhoids to receive either rubber band ligation or haemorrhoidal artery ligation.

Rubber band ligation is a less invasive, outpatient procedure, but has a greater chance of haemorrhoids returning. Haemorrhoidal artery ligation has lower rates of recurrence but requires anaesthetic and has a risk of complications. The main outcome was recurrence of haemorrhoids, measured using patient self-report and GP and hospital records.

More people assigned to receive artery ligation dropped out of the trial before treatment was given (13%) compared to rubber banding ligation (4%). Also a higher proportion of people receiving banding had less serious haemorrhoids (65% vs. 57% for artery ligation), but the randomisation process ensured that patient characteristics didn’t influence treatment allocation.

What did it find?

  • Recurrence of haemorrhoids at 12 months (the primary outcome) was more common for people who had rubber band ligation (49%) than haemorrhoidal artery ligation (30%; adjusted odds ratio [aOR] 2.23, 95% confidence interval [CI] 1.42 to 3.51). A repeat procedure was needed by 32% who received banding compared with only 14% who received artery ligation.
  • Pain was significantly lower one day after the procedure with rubber band ligation: 3.4 on a 10-point scale compared with 4.6 after artery ligation (mean difference [MD] ‑1.2, 95% CI ‑1.8 to ‑0.5). At seven days rubber band ligation pain was still lower (1.6 vs. 3.1; MD ‑1.5, 95% CI ‑2.0 to ‑1.0). By three to six weeks there was no significant difference in pain (MD 0.2, 95% CI ‑0.2 to 0.7).
  • Serious adverse events occurred more frequently with haemorrhoidal artery ligation (12 people, 7%) than rubber band ligation (two people, 1%). Those in the artery ligation group included pain, bleeding, urine retention and infection.
  • Haemorrhoidal artery ligation had zero probability of being cost effective at a willingness-to-pay threshold of £20,000 per quality adjusted life year. Total costs were on average £1,027 higher for artery ligation than for rubber band ligation.

What does current guidance say on this issue?

2010 NICE guidance considers haemorrhoidal artery ligation to be a safe and effective alternative to conventional surgical options to remove the haemorrhoids (haemorrhoidectomy or stapled haemorrhoidopexy) in the short and medium term.

What are the implications?

Rubber band ligation led to a greater chance of haemorrhoid recurrence requiring further treatment but less short-term pain than haemorrhoidal artery ligation.

Rubber band ligation can be performed at an outpatient clinic, and does not require admission and a general anaesthetic. Therefore, the choice for patients is largely dependent on their preferences. It seems like the newer procedure is not a good buy for the NHS on the cost-effectiveness  grounds reported here. With a higher overall cost for the newer procedure it may not be favoured by commissioners either.

However, individual patient preferences and the severity of haemorrhoids are likely to be the main deciding factor when choosing between a non-surgical treatment such as banding or one of the surgical options.

Citation and Funding

Brown SR, Tiernan JP, Watson AJ, et al; HubBLe Study team. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. Lancet. 2016;388(10042):356-64.

This project was funded by the National Institute for Health Research (Health Technology Assessment programme) (project number 10/57/46).

Bibliography

NICE. Haemorrhoidal artery ligation. IPG342. London: National Institute for Health and Care Excellence; 2010.

NICE. Electrotherapy for the treatment of haemorrhoids. IPG525. London: National Institute for Health and Care Excellence; 2015.

NICE. Stapled haemorrhoidopexy for the treatment of haemorrhoids. TA128. London: National Institute for Health and Care Excellence; 2007.

NICE. Circular stapled haemorrhoidectomy. IPG34. London: National Institute for Health and Care Excellence; 2003.

Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial

Published on 25 May 2016

S Brown, J Tiernan, A Watson, K Biggs, N Shephard, A Wailoo, M Bradburn, A Alshreef, D Hind, The HubBLe Study team

The Lancet , 2016

Background Optimum surgical intervention for low-grade haemorrhoids is unknown. Haemorrhoidal artery ligation (HAL) has been proposed as an efficacious, safe therapy while rubber band ligation (RBL) is a commonly used outpatient treatment. We compared recurrence after HAL versus RBL in patients with grade II–III haemorrhoids. Methods This multicentre, open-label, parallel group, randomised controlled trial included patients from 17 acute UK NHS trusts. We screened patients aged 18 years or older presenting with grade II–III haemorrhoids. We excluded patients who had previously received any haemorrhoid surgery, more than one injection treatment for haemorrhoids, or more than one RBL procedure within 3 years before recruitment. Eligible patients were randomly assigned (in a 1:1 ratio) to either RBL or HAL with Doppler. Randomisation was computer-generated and stratified by centre with blocks of random sizes. Allocation concealment was achieved using a web-based system. The study was open-label with no masking of participants, clinicians, or research staff. The primary outcome was recurrence at 1 year, derived from the patient's self-reported assessment in combination with resource use from their general practitioner and hospital records. Recurrence was analysed in patients who had undergone one of the interventions and been followed up for at least 1 year. This study is registered with the ISRCTN registry, ISRCTN41394716. Findings From Sept 9, 2012, to May 6, 2014, of 969 patients screened, 185 were randomly assigned to the HAL group and 187 to the RBL group. Of these participants, 337 had primary outcome data (176 in the RBL group and 161 in the HAL group). At 1 year post-procedure, 87 (49%) of 176 patients in the RBL group and 48 (30%) of 161 patients in the HAL group had haemorrhoid recurrence (adjusted odds ratio [aOR] 2·23, 95% CI 1·42–3·51; p=0·0005). The main reason for this difference was the number of extra procedures required to achieve improvement (57 [32%] participants in the RBL group and 23 [14%] participants in the HAL group had a subsequent procedure for haemorrhoids). The mean pain 1 day after procedure was 3·4 (SD 2·8) in the RBL group and 4·6 (2·8) in the HAL group (difference −1·2, 95% CI −1·8 to −0·5; p=0·0002); at day 7 the scores were 1·6 (2·3) in the RBL group and 3·1 (2·4) in the HAL group (difference −1·5, −2·0 to −1·0; p<0·0001). Pain scores did not differ between groups at 21 days and 6 weeks. 15 individuals reported serious adverse events requiring hospital admission. One patient in the RBL group had a pre-existing rectal tumour. Of the remaining 14 serious adverse events, 12 (7%) were among participants treated with HAL and two (1%) were in those treated with RBL. Six patients had pain (one treated with RBL, five treated with HAL), three had bleeding not requiring transfusion (one treated with RBL, two treated with HAL), two in the HAL group had urinary retention, two in the HAL group had vasovagal upset, and one in the HAL group had possible sepsis (treated with antibiotics). Interpretation Although recurrence after HAL was lower than a single RBL, HAL was more painful than RBL. The difference in recurrence was due to the need for repeat bandings in the RBL group. Patients (and health commissioners) might prefer such a course of RBL to the more invasive HAL. Funding NIHR Health Technology Assessment programme.

For more severe symptoms of haemorrhoids rubber band ligation is a very commonly performed procedure in surgical outpatients or clinic.

More major surgical techniques, in the operating theatre, include treatments that remove the haemorrhoidal cushions (haemorrhoidectomy) or those that preserve the cushions but reduce the vascular engorgement and replace the cushions in a more anatomical position (stapled haemorrhoidopexy).

More recently haemorrhoidal artery ligation has been introduced as a surgical option. Although it requires anaesthetic, recovery is rapid, the complication rate is low and the recurrence rate appears significantly lower that rubber band ligation.

Expert commentary

Haemorrhoidal disease is common, affecting about a third of the population. Rubber band ligation is an effective treatment particularly when considered to be a course of treatment with repeat banding as necessary. While the haemorrhoidal artery ligation procedure has a lower recurrence rate when compared with a single banding episode it is more costly and associated with more post procedure pain. It may be that we should now offer patients a course of banding rather than haemorrhoidal artery ligation surgery.

Miss Patricia Boorman, Consultant Colorectal Surgeon, Royal Devon & Exeter NHS Foundation Trust

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