eTHoS piles pressure on haemorrhoidopexy
Authors: Simon P Bach, Nicola S Fearnhead
Journal: The Lancet (2016)

Surgical innovation strives to address the perceived shortcomings and potential pitfalls associated with traditional therapeutic techniques. New devices are often recommended to patients on the basis of incomplete clinical datasets that highlight specific short-term gains over standard treatment but may not confirm long-term benefit. Enthusiasm for new technology in surgery should be balanced by the requirement to undertake objective, high-quality studies to establish the overall clinical and economic effect of surgical therapies.1National Institute for Health and Care ExcellenceGuide to the processes of technology appraisal.https://www.nice.org.uk/article/pmg19Date: 2014Google Scholar In The Lancet, Angus Watson and colleagues present eTHoS,2Watson AJM Hudson J Wood J et al.on behalf of the eTHoS study groupComparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.Lancet. 2016; (published online Oct 7.)http://dx.doi.org/10.1016/S0140-6736(16)31803-7Summary Full Text Full Text PDF Scopus (92) Google Scholar a randomised, non-blinded, multicentre, phase 3 study assessing clinical outcomes and cost-effectiveness for treatment of moderate or severe haemorrhoids using novel stapled haemorrhoidopexy versus the long-established traditional excisional haemorrhoidectomy.2Watson AJM Hudson J Wood J et al.on behalf of the eTHoS study groupComparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.Lancet. 2016; (published online Oct 7.)http://dx.doi.org/10.1016/S0140-6736(16)31803-7Summary Full Text Full Text PDF Scopus (92) Google Scholar These outcomes are of importance as each year millions of people are affected by haemorrhoids worldwide;3Jacobs D Clinical practice. Hemorrhoids.New Engl J Med. 2014; 371: 944-951Crossref PubMed Scopus (66) Google Scholar the UK National Health Service carries out in excess of 20 000 haemorrhoidal treatments.4Hospital Episode StatisticsAdmitted patient care, England 2012–13: procedures and interventions. Main procedures and interventions.http://www.hscic.gov.uk/catalogue/PUB12566/hosp-epis-stat-admi-proc-2012-13-tab.xlsxDate: 2013Google Scholar Traditional haemorrhoidectomy excises symptomatic tissue from the anal canal leaving wounds that usually take 6 weeks to heal.5Milligan ETC Naunton Morgan C Jones L Officer R Surgical anatomy of the anal canal, and the operative treatment of haemorrhoids.Lancet. 1937; 230: 1119-1124Abstract Scopus (370) Google Scholar Surgeons often contend that traditional haemorrhoidectomy is a good treatment for haemorrhoids, the axiom of “6 weeks' pain for 5 years' gain” has long been touted, although surprisingly little high-quality evidence exists to support this position.6Simillis C Thoukididou SN Slesser AA Rasheed S Tan E Tekkis PP Systematic review and network meta-analysis comparing clinical outcomes and effectiveness of surgical treatments for haemorrhoids.Br J Surg. 2015; 102: 1603-1618Crossref PubMed Scopus (123) Google Scholar Patients experience short-term discomfort after traditional haemorrhoidectomy until their anal canal wounds heal, and, if severe, this pain might give rise to additional problems such as a fear of evacuation, constipation, and an inability to pass urine requiring catheterisation. Stapled haemorrhoidopexy was specifically developed to tackle the problem of early pain after traditional haemorrhoidectomy.7Corman ML Gravie JF Hager T et al.Stapled haemorrhoidopexy: a consensus position paper by an international working party—indications, contra-indications and technique.Colorectal Dis. 2003; 5: 304-310Crossref PubMed Scopus (155) Google Scholar A ring of tissue is excised from the relatively insensate, viscerally innervated upper anal canal, with the cut edges simultaneously brought together and fixed by a circle of staples. Traction draws the prolapsing haemorrhoids into the anal canal where they remain fixed (pexy). Stapling might also interrupt the submucosal blood flow to haemorrhoids, thereby reducing symptoms of bleeding. Initial experience reinforced the view that stapled haemorrhoidopexy was less painful for patients than traditional haemorrhoidectomy, however, severe unexpected complications were also reported, most notably chronic anal pain and rectovaginal fistula.8Faucheron JL Voirin D Abba J Rectal perforation with life-threatening peritonitis following stapled haemorrhoidopexy.Br J Surg. 2012; 99: 746-753Crossref PubMed Scopus (51) Google Scholar, 9Cheetham MJ Mortensen NJ Nystrom PO Kamm MA Phillips RK Persistent pain and faecal urgency after stapled haemorrhoidectomy.Lancet. 2000; 356: 730-733Summary Full Text Full Text PDF PubMed Scopus (317) Google Scholar A large number of procedures have been done worldwide, and 14 000 cases have been published,10Porrett LJ Porrett JK Ho YH Documented complications of staple hemorrhoidopexy: a systematic review.Int Surg. 2015; 100: 44-57Crossref PubMed Scopus (35) Google Scholar but the efficacy of stapled haemorrhoidectomy in relation to traditional haemorrhoidectomy remains unknown.11Laughlan K Jayne DG Jackson D Rupprecht F Ribaric G Stapled haemorrhoidopexy compared to Milligan-Morgan and Ferguson haemorrhoidectomy: a systematic review.Int J Colorectal Dis. 2009; 24: 335-344Crossref PubMed Scopus (77) Google Scholar Between 2011 and 2014, eTHoS randomised 777 patients with symptomatic grade 2–4 haemorrhoids to stapled haemorrhoidopexy (n=389) or traditional haemorrhoidectomy (n=388) at 32 UK sites.2Watson AJM Hudson J Wood J et al.on behalf of the eTHoS study groupComparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.Lancet. 2016; (published online Oct 7.)http://dx.doi.org/10.1016/S0140-6736(16)31803-7Summary Full Text Full Text PDF Scopus (92) Google Scholar Patients who had previously not responded well to treatment with rubber band ligation or haemorrhoidal artery ligation were eligible, in addition to cases where such techniques were deemed unsuitable on account of large size. Previous traditional haemorrhoidectomy or stapled haemorrhoidopexy constituted exclusions. The primary outcome comprised serial assessment of quality of life with the use of EuroQol 5 dimensions (EQ-5D) over a 2-year period, expressed as the area under the curve (AUC), so capturing both early and late effects of surgery. The investigators showed that EQ-5D AUC (24 months) was significantly higher (better) in the traditional haemorrhoidectomy group than in the novel stapled haemorrhoidopexy (mean difference −0·073 [95% CI −0·140 to −0·006]; p=0·0342). Stapled haemorrhoidopexy was much more expensive than traditional haemorrhoidectomy, with respective mean costs of £941 (SD 415) per patient versus £602 (507) for traditional excisional haemorrhoidectomy, leading to higher cost per quality-adjusted life-year for stapled haemorrhoidopexy. Notably, use of expensive modern energy devices for traditional haemorrhoidectomy12Mushaya CD Caleo PJ Bartlett L Buettner PG Ho YH Harmonic scalpel compared with conventional excisional haemorrhoidectomy: a meta-analysis of randomized controlled trials.Tech Coloproctol. 2014; 18: 1009-1016Crossref PubMed Scopus (20) Google Scholar was precluded in eTHoS. In the immediate postoperative period, stapled haemorrhoidopexy provided superior quality of life compared with traditional haemorrhoidectomy for up to 6 weeks. Participants reported better pain scores for stapled haemorrhoidopexy at 1 and 3 weeks, but by 6 weeks, any benefit was lost. This early benefit for stapled haemorrhoidopexy was subsequently overshadowed by consistent medium-term and longer term gains for traditional haemorrhoidectomy. At 12 and 24 months EQ-5D unequivocally favoured traditional haemorrhoidectomy. Traditional haemorrhoidectomy consistently improved (reduced) Cleveland incontinence scores and haemorrhoid symptom scores by a small but significant margin. The proportion of patients who reported that their haemorrhoids had recurred at 12 months was only 14% (39/278) for traditional haemorrhoidectomy compared with 32% (94/295) for stapled haemorrhoidopexy. Complication rates were reassuringly similar and low for both procedures, a testimony to the high quality of surgery delivered throughout the trial. No episodes of rectal perforation occurred. At 12 months, the debilitating symptom of tenesmus regularly affected (ie, always or often) 13% (38/295) of patients who had stapled haemorrhoidopexy compared with 4% (11/278) who had traditional haemorrhoidectomy. These findings add to those of the HubBLe study.13Brown SR Tiernan JP Watson AJ et al.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: 356-364Summary Full Text Full Text PDF PubMed Scopus (119) Google Scholar Together HubBLe and eTHoS have set a benchmark for assessment of technological innovation across the spectrum of haemorrhoidal disease. In both studies, the novel pexy approach has proven inferior to conventional treatment. For mild to moderate haemorrhoids, haemorrhoidal artery ligation was no better than a course of banding but incurred much more cost.13Brown SR Tiernan JP Watson AJ et al.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: 356-364Summary Full Text Full Text PDF PubMed Scopus (119) Google Scholar For moderate to severe haemorrhoids, although stapled haemorrhoidopexy produced less short-term pain than traditional haemorrhoidectomy, longer term outcomes were worse and costs much more.2Watson AJM Hudson J Wood J et al.on behalf of the eTHoS study groupComparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.Lancet. 2016; (published online Oct 7.)http://dx.doi.org/10.1016/S0140-6736(16)31803-7Summary Full Text Full Text PDF Scopus (92) Google Scholar Since 2007, the National Institute for Health and Care Excellence (NICE) has recommended use of stapled haemorrhoidopexy for patients with prolapsed haemorrhoids; the only qualifier being that surgery was considered a suitable treatment.14National Institute for Health and Care ExcellenceTA128 Stapled haemorrhoidopexy for the treatment of haemorrhoids.https://www.nice.org.uk/guidance/ta128/resources/stapled-haemorrhoidopexy-for-the-treatment-of-haemorrhoids-82598140063429Date: 2007Google Scholar In retrospect, this approval was premature as even then, available evidence pointed to higher failure and reintervention rates for stapled haemorrhoidopexy than for traditional haemorrhoidectomy. Cost-effectiveness was also questioned at the time. Although innovation is to be encouraged, unproven devices should be assessed in the context of suitable prospective clinical studies as NICE belatedly acknowledged in dealing with use of colonic stents for obstructing bowel cancer.15National Institute for Health and Care ExcellenceNICE updates guidance on colorectal cancer.https://www.nice.org.uk/news/press-and-media/nice-updates-guidance-on-colorectal-cancerDate: 2014Google Scholar Finally, and long overdue, these studies provide high-quality information for patients with haemorrhoids on what to expect after standard surgical treatment; 5 weeks' pain with a high probability of at least 2 years gain. The search continues for an effective painless approach to haemorrhoid treatment. SPB provides consulting services and advice on product development to Ethicon Inc, Cincinatti, USA, which manufactures one of the haemorrhoidopexy stapling devices (PPH) used in this study. SPB took no part in the development of PPH but has consulted on other stapling projects. NSF declares no competing interests. Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trialAs part of a tailored management plan for haemorrhoids, traditional excisional surgery should be considered over stapled haemorrhoidopexy as the surgical treatment of choice. Full-Text PDF Open Access