NIHR DC Discover

NIHR Signal Excision is probably better than stapling in the long-term for haemorrhoids

Published on 31 January 2017

doi: 10.3310/signal-000370

Recurrences of haemorrhoids (piles) are three times less likely if they are surgically removed rather than treated with a relatively new stapling procedure.

There are now a wide range of techniques to tackle this common, distressing condition. Some, such as stapling, have become more popular despite a lack of evidence about improved long-term outcomes. This NIHR-funded trial compared both operations for moderate to severe haemorrhoids across multiple sites in the UK.

Quality of life was similar following either procedure up to two years, but ongoing symptoms such as incontinence were slightly less likely with surgical removal. Pain was initially a little worse with surgical removal and this was successfully managed with pain killers.

As stapling appears to be less effective and more expensive, traditional surgical removal may be the better value treatment for haemorrhoids of this severity.

Share your views on the research.

Why was this study needed?

Haemorrhoids affect about a third of the UK population. For most people with haemorrhoids, the swollen blood vessels and tissues in the anus (back passage) lead to discomfort and light bleeding. Many resolve after advice on a high-fibre diet, increased fluid intake and judicious use of laxatives. Less severe but persistent haemorrhoids may be managed by injection or rubber band ligation of the swollen veins or ligation of the artery supplying them. The recent NIHR signal on the HubBLe trial discusses the pros and cons of minor procedures for low grade haemorrhoids.

In moderate to severe haemorrhoids other options are traditional excision, where the haemorrhoid is surgically removed, or stapled haemorrhoidopexy, with removal of a ring of tissue above the haemorrhoid and then stapling the join. The staple technique was thought to lead to less pain and a quicker recovery time, but long-term differences between these procedures was not known.

What did this study do?

The eTHoS trial was NIHR funded and randomly allocated 774 people to have traditional excisional surgery or stapled haemorrhoidopexy. The haemorrhoids were moderate to severe and a third of the participants had already had rubber band treatment or artery ligation. The two groups of patients were well-matched by age, gender, severity of haemorrhoids and other factors that could have affected their outcomes.

This was a pragmatically designed trial, which has some advantages in ensuring its relevance to the NHS but also led to some minor limitations. Due to the nature of the operations, surgeons and participants were not able to be blinded to the treatment allocation, though outcome assessors were. In addition, some patients either received a different operation to the one they had been allocated (66 people) or no operation (53 people), but the study authors re-ran their analysis and found that this did not impact the results. Some participants were not followed up for the full time, but the trial still had enough participants to draw reliable conclusions.

What did it find?

  • Quality of life was assessed using the EQ-5D-3L scale, range ‑0.59 worst to 1.0 best quality. Though quality of life was initially marginally higher for stapled haemorrhoidopexy, there was no difference at 12 months and minimal difference in favour of traditional excision up to 24 months. However, this difference was not clinically meaningful (area under the curve mean difference ‑0.073, 95% confidence interval [CI] ‑0.140 to ‑0.006).
  • Pain was lower in the stapled haemorrhoidopexy group in the short-term up to three weeks, but there was no difference after six weeks according to a 10 point scale (mean difference ‑0.01, 95% CI ‑0.35 to 0.33).
  • Recurrence of haemorrhoids was about three times more likely in the stapled haemorrhoidopexy group than the traditional excision group at 12 months (32% versus 14%; odds ratio [OR] 2.96, 95% CI 2.02 to 4.32). A similar pattern was seen at 24 months (42% versus 25%; OR 2.25, 95% CI 1.46 to 3.46).
  • Incontinence, haemorrhoid-related symptoms and tenesmus (feeling the need to pass stools) were less common after traditional excision by 12 months and 24 months.
  • The cost of stapled haemorrhoidopexy was £941, compared to £602 for traditional excision – resulting in an adjusted mean difference in total costs of £337 per patient. Quality adjusted life years (QALYs) were similar, with a mean difference of ‑0.07 (95% CI ‑0.127 to ‑0.011). As a result, stapled haemorrhoidoplexy compared to traditional surgery has a 0.1% chance of being cost effective at the usual NHS thresholds of £20,000 and £30,000.

What does current guidance say on this issue?

2007 NICE guidance concluded that stapled haemorrhoidopexy is a safe and effective surgical procedure in the treatment of prolapsed internal haemorrhoids. NICE Clinical Knowledge Summaries do not recommend one surgical treatment over another. Options include traditional excision, stapled haemorrhoidopexy or haemorrhoidal artery ligation.

These surgical procedures are only recommended if the haemorrhoids remain symptomatic, as there is a risk of complications such as abscess, fistula and incontinence.

What are the implications?

The findings indicate that traditional excision is more likely to prevent recurrent haemorrhoids, and may reduce incontinence and other symptoms more than stapled haemorrhoidopexy, but is more painful at three weeks.

The study highlights the need for anticipating and managing post-operative problems such as pain effectively, especially for haemorrhoidal excision. At an individual level this reinforces the need for patients to be aware of the differences in outcomes, should they wish to choose.

From a population perspective the similar long term outcomes such as quality of life, combined with the higher cost of stapled haemorrhoidopexy, suggest that the traditional excision is better value for money for the NHS. Commissioners might want to consider the priorities for their communities. Savings could come from a reduction in repeat procedures if using traditional excision haemorrhoidopexy.

Citation and Funding

Watson AJ, Hudson J, Wood J, et al; eTHoS study group. Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial. Lancet. 2016; 388(10058):2375-85.

This project was funded by the National Institute for Health Research Health Technology Assessment programme (project number 08/24/02).

Bibliography

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

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

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

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

Why was this study needed?

Haemorrhoids affect about a third of the UK population. For most people with haemorrhoids, the swollen blood vessels and tissues in the anus (back passage) lead to discomfort and light bleeding. Many resolve after advice on a high-fibre diet, increased fluid intake and judicious use of laxatives. Less severe but persistent haemorrhoids may be managed by injection or rubber band ligation of the swollen veins or ligation of the artery supplying them. The recent NIHR signal on the HubBLe trial discusses the pros and cons of minor procedures for low grade haemorrhoids.

In moderate to severe haemorrhoids other options are traditional excision, where the haemorrhoid is surgically removed, or stapled haemorrhoidopexy, with removal of a ring of tissue above the haemorrhoid and then stapling the join. The staple technique was thought to lead to less pain and a quicker recovery time, but long-term differences between these procedures was not known.

What did this study do?

The eTHoS trial was NIHR funded and randomly allocated 774 people to have traditional excisional surgery or stapled haemorrhoidopexy. The haemorrhoids were moderate to severe and a third of the participants had already had rubber band treatment or artery ligation. The two groups of patients were well-matched by age, gender, severity of haemorrhoids and other factors that could have affected their outcomes.

This was a pragmatically designed trial, which has some advantages in ensuring its relevance to the NHS but also led to some minor limitations. Due to the nature of the operations, surgeons and participants were not able to be blinded to the treatment allocation, though outcome assessors were. In addition, some patients either received a different operation to the one they had been allocated (66 people) or no operation (53 people), but the study authors re-ran their analysis and found that this did not impact the results. Some participants were not followed up for the full time, but the trial still had enough participants to draw reliable conclusions.

What did it find?

  • Quality of life was assessed using the EQ-5D-3L scale, range ‑0.59 worst to 1.0 best quality. Though quality of life was initially marginally higher for stapled haemorrhoidopexy, there was no difference at 12 months and minimal difference in favour of traditional excision up to 24 months. However, this difference was not clinically meaningful (area under the curve mean difference ‑0.073, 95% confidence interval [CI] ‑0.140 to ‑0.006).
  • Pain was lower in the stapled haemorrhoidopexy group in the short-term up to three weeks, but there was no difference after six weeks according to a 10 point scale (mean difference ‑0.01, 95% CI ‑0.35 to 0.33).
  • Recurrence of haemorrhoids was about three times more likely in the stapled haemorrhoidopexy group than the traditional excision group at 12 months (32% versus 14%; odds ratio [OR] 2.96, 95% CI 2.02 to 4.32). A similar pattern was seen at 24 months (42% versus 25%; OR 2.25, 95% CI 1.46 to 3.46).
  • Incontinence, haemorrhoid-related symptoms and tenesmus (feeling the need to pass stools) were less common after traditional excision by 12 months and 24 months.
  • The cost of stapled haemorrhoidopexy was £941, compared to £602 for traditional excision – resulting in an adjusted mean difference in total costs of £337 per patient. Quality adjusted life years (QALYs) were similar, with a mean difference of ‑0.07 (95% CI ‑0.127 to ‑0.011). As a result, stapled haemorrhoidoplexy compared to traditional surgery has a 0.1% chance of being cost effective at the usual NHS thresholds of £20,000 and £30,000.

What does current guidance say on this issue?

2007 NICE guidance concluded that stapled haemorrhoidopexy is a safe and effective surgical procedure in the treatment of prolapsed internal haemorrhoids. NICE Clinical Knowledge Summaries do not recommend one surgical treatment over another. Options include traditional excision, stapled haemorrhoidopexy or haemorrhoidal artery ligation.

These surgical procedures are only recommended if the haemorrhoids remain symptomatic, as there is a risk of complications such as abscess, fistula and incontinence.

What are the implications?

The findings indicate that traditional excision is more likely to prevent recurrent haemorrhoids, and may reduce incontinence and other symptoms more than stapled haemorrhoidopexy, but is more painful at three weeks.

The study highlights the need for anticipating and managing post-operative problems such as pain effectively, especially for haemorrhoidal excision. At an individual level this reinforces the need for patients to be aware of the differences in outcomes, should they wish to choose.

From a population perspective the similar long term outcomes such as quality of life, combined with the higher cost of stapled haemorrhoidopexy, suggest that the traditional excision is better value for money for the NHS. Commissioners might want to consider the priorities for their communities. Savings could come from a reduction in repeat procedures if using traditional excision haemorrhoidopexy.

Citation and Funding

Watson AJ, Hudson J, Wood J, et al; eTHoS study group. Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial. Lancet. 2016; 388(10058):2375-85.

This project was funded by the National Institute for Health Research Health Technology Assessment programme (project number 08/24/02).

Bibliography

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

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

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

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

Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial

Published on 10 October 2016

A Watson, J Hudson, J Wood, M Kilonzo, S Brown, A McDonald, J Norrie, H Bruhn, J Cook

The Lancet , 2016

Background Two commonly performed surgical interventions are available for severe (grade II–IV) haemorrhoids; traditional excisional surgery and stapled haemorrhoidopexy. Uncertainty exists as to which is most effective. The eTHoS trial was designed to establish the clinical effectiveness and cost-effectiveness of stapled haemorrhoidopexy compared with traditional excisional surgery. Methods The eTHoS trial was a large, open-label, multicentre, parallel-group, pragmatic randomised controlled trial done in adult participants (aged 18 years or older) referred to hospital for surgical treatment for grade II–IV haemorrhoids. Participants were randomly assigned (1:1) to receive either traditional excisional surgery or stapled haemorrhoidopexy. Randomisation was minimised according to baseline EuroQol 5 dimensions 3 level score (EQ-5D-3L), haemorrhoid grade, sex, and centre with an automated system to stapled haemorrhoidopexy or traditional excisional surgery. The primary outcome was area under the quality of life curve (AUC) measured with the EQ-5D-3L descriptive system over 24 months, assessed according to the randomised groups. The primary outcome measure was analysed using linear regression with adjustment for the minimisation variables. This trial is registered with the ISRCTN registry, number ISRCTN80061723. Findings Between Jan 13, 2011, and Aug 1, 2014, 777 patients were randomised (389 to receive stapled haemorrhoidopexy and 388 to receive traditional excisional surgery). Stapled haemorrhoidopexy was less painful than traditional excisional surgery in the short term and surgical complication rates were similar between groups. The EQ-5D-3L AUC score was higher in the traditional excisional surgery group than the stapled haemorrhoidopexy group over 24 months; mean difference −0·073 (95% CI −0·140 to −0·006; p=0·0342). EQ-5D-3L was higher for stapled haemorrhoidopexy in the first 6 weeks after surgery, the traditional excisional surgery group had significantly better quality of life scores than the stapled haemorrhoidopexy group. 24 (7%) of 338 participants who received stapled haemorrhoidopexy and 33 (9%) of 352 participants who received traditional excisional surgery had serious adverse events. Interpretation As part of a tailored management plan for haemorrhoids, traditional excisional surgery should be considered over stapled haemorrhoidopexy as the surgical treatment of choice. Funding National Institute for Health Research Health Technology Assessment programme.

EuroQol 5 dimensions 3 level (EQ-5D-3L): The scale range is from ‑0.59 to 1.0 with values nearer to 1.0 denoting better health states. The five dimensions include: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The score is calculated by considering if there are no problems, some problems or extreme problems in each dimension.

Expert commentary

Problematic haemorrhoids have a myriad of treatment options available, none of which is ideal. This has led to the development of new technologies claiming to improve on traditional surgery. Unfortunately challenges in randomisation and patient acceptance have led to a lack of high quality research to evidence this benefit.

This trial has shown us that traditional excisional surgery still has a place in the treatment of haemorrhoids. Patients may tolerate more early post-operative pain in exchange for improved long-term quality of life. Unbiased informed consent is crucial in benign proctology and must also describe the significant serious adverse event rate.

Mr Kenneth Keogh, ST8 Colorectal Surgery