| Riassunto: | <h4>Background</h4> <p>Two commonly performed surgical interventions are available for more severe haemorrhoids (Grade II, III and IV); traditional excisional surgery (TH) and stapled haemorrhoidopexy (SH). Uncertainty exists as to which is most effective. The eTHoS trial was designed to determine the clinical and cost-effectiveness of SH compared to TH.</p> <h4>Methods</h4> <p>A large, open-label 2 arm parallel group pragmatic multicentre randomised controlled trial involving 32 United Kingdom hospitals was performed for adult participants with Grade II, III and IV haemorrhoids. The primary outcome was area under the quality of life curve (AUC QoL) measured using the Euroqol-5D-3L (EQ-5D) descriptive system over 24 months. Secondary outcomes included disease-specific QoL, recurrence, complications, further interventions and cost effectiveness. Randomisation was minimised, 1:1 according to baseline EQ-5D, haemorrhoid grade, gender and centre via an automated system to SH or TH. The primary outcome measure was analysed using linear regression with adjustment for the minimisation variables. This study is registered with the ISRCTN registry, ISRCTN80061723.</p> <h4>Findings</h4> <p>Between January 2011 and August 2014, 777 patients were randomised (SH 389, TH 388). SH was less painful than TH in the short term. Surgical complication rates were similar. EQ-5D AUC favoured TH; -0.073 95 % CI (-0.140,-0.006); p-value 0.0342. EQ-5D was higher for SH in the first 6 weeks after surgery but over 24 months the TH group had significantly better QoL scores. Symptoms and further interventions were significantly less in TH over 24 months. Incontinence was better in TH and tenesmus was less. SH was dominated by TH as it cost more than TH and was less effective than TH.</p> <h4>Interpretation</h4> <p>This is the largest trial of its kind. SH had less short-term pain but, after 6 weeks, recurrence rates, symptoms, re-interventions and quality of life measures significantly favour TH. In addition, TH is cheaper. As part of a tailored management plan for haemorrhoids, TH should be considered over SH as the surgical treatment of choice.</p>
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