A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease: the eTHoS study

• Published in: Health technology assessment (Winchester, England) England), 2017-11, Vol.21 (70), p.1-224
• Main Authors: Watson, Angus Jm, Cook, Jonathan, Hudson, Jemma, Kilonzo, Mary, Wood, Jessica, Bruhn, Hanne, Brown, Steven, Buckley, Brian, Curran, Finlay, Jayne, David, Loudon, Malcolm, Rajagopal, Ramesh, McDonald, Alison, Norrie, John
• Format: Article
• Language: English
• Subjects: Adult; Cost-Benefit Analysis; cost-effectiveness; ethos; Female; haemorrhoidal disease; haemorrhoidectomy; haemorrhoidopexy; Hemorrhoidectomy - economics; Hemorrhoidectomy - methods; Hemorrhoids - economics; Hemorrhoids - surgery; Humans; Male; Middle Aged; multicentre; Quality of Life; randomised controlled trial; Surgical Stapling - economics; Surgical Stapling - methods
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/hta21700

Haemorrhoids are a benign anorectal condition and are highly prevalent in the UK population. Treatments involve clinic-based procedures and surgery. The surgical procedures available include stapled haemorrhoidopexy (SH) and traditional haemorrhoidectomy (TH), and over 25,000 operations are performed for haemorrhoids annually in the UK. The disease is therefore important both to patients and to health service commissioners. Debate remains as to which of these surgical procedures is the most clinically effective and cost-effective. The aim of this study was to compare the clinical effectiveness and cost-effectiveness of SH with that of TH. A large, open two-arm parallel-group pragmatic multicentre randomised controlled trial involving 32 UK hospitals and a within-trial cost-benefit analysis. A discrete choice experiment was conducted to estimate benefits (willingness to pay). Patients with grades II-IV haemorrhoids who had not previously undergone SH or TH were included in the study. Participants were randomised to receive either SH or TH. Randomisation was minimised at 1 : 1, in accordance with baseline EuroQol-5 Dimensions, three-level version (EQ-5D-3L) score, haemorrhoid grade, sex and centre, via an automated system. The primary outcome was area under the quality-of-life curve measured using the EQ-5D-3L descriptive system over 24 months, and the primary economic outcome was the incremental cost-effectiveness ratio. Secondary outcomes included disease-specific quality of life, recurrence, complications, further interventions and costs. Between January 2011 and August 2014, 777 patients were randomised (389 to receive SH and 388 to receive TH). There were 774 participants included in the analysis as a result of one post-randomisation exclusion in the SH arm and two in the TH arm. SH was less painful than TH in the short term. Surgical complications were similar in both arms. EQ-5D-3L score was higher for the SH arm in the first 6 weeks after surgery, but over 24 months the TH group had significantly better EQ-5D-3L scores (-0.073, 95% confidence interval -0.140 to -0.006;  = 0.0342). Symptoms and further interventions were significantly fewer in the TH arm at 24 months. Continence was better in the TH arm and tenesmus occurred less frequently. The number of serious adverse events reported was 24 out of 337 (7.1%) for participants who received SH and 33 out of 352 (9.4%) for those who received TH. There were two deaths in the SH arm, both unrelated to th