eTHoS piles pressure on haemorrhoidopexy

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 specifi c short-term gains over standard treatment but may not confi rm longterm benefi t. 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 eff ect of surgical therapies. In The Lancet, Angus Watson and colleagues present eTHoS, a randomised, non-blinded, multicentre, phase 3 study assessing clinical outcomes and cost-eff ectiveness for treatment of moderate or severe haemorrhoids using novel stapled haemorrhoidopexy versus the longestablished traditional excisional haemorrhoidectomy. These outcomes are of importance as each year millions of people are aff ected by haemorrhoids worldwide; the UK National Health Service carries out in excess of 20 000 haemorrhoidal treatments. Traditional haemorrhoidectomy excises symptomatic tissue from the anal canal leaving wounds that usually take 6 weeks to heal. 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. 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 specifi cally developed to tackle the problem of early pain after traditional haemorrhoidectomy. A ring of tissue is excised from the relatively insensate, viscerally innervated upper anal canal, with the cut edges simultaneously brought together and fi xed by a circle of staples. Traction draws the prolapsing haemorrhoids into the anal canal where they remain fi xed (pexy). Stapling might also interrupt the submucosal blood fl ow 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 fi stula. A large number of procedures have been done worldwide, and 14 000 cases have been published, but the effi cacy of stapled haemorrhoidectomy in relation to traditional haemorrhoidectomy remains unknown. 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. 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 eff ects of surgery. The investigators showed that EQ-5D AUC (24 months) was signifi cantly higher (better) in the traditional haemorrhoidectomy group than in the novel stapled haemorrhoidopexy (mean diff erence –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 haemorrhoidectomy 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 benefi t was lost. This early benefi t 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 Published Online October 7, 2016 http://dx.doi.org/10.1016/ S0140-6736(16)31802-5