Comparison of Stapled Haemorrhoidopexy with Traditional Excisional Surgery for Haemorrhoidal Disease (eTHoS): A Pragmatic, Multicentre, Randomised Controlled Trial

Background

Two commonly performed surgical interventions are available for severe (grade II−IV) hemorrhoids: traditional excisional surgery and stapled 133hemorrhoidopexy. Uncertainty exists as to which is most effective. The eTHoS trial was designed to establish the clinical effectiveness and cost effectiveness of stapled hemorrhoidopexy compared with traditional excisional surgery.

Methods

The eTHoS trial was a large, open-label, multicenter, parallel-group, pragmatic randomized controlled trial done in adult participants (aged 18 years or older) referred to hospital for surgical treatment for grade II−IV hemorrhoids. Participants were randomly assigned (1:1) to receive either traditional excisional surgery or stapled hemorrhoidopexy. Randomization was minimized according to baseline EuroQol 5 dimensions 3 level score (EQ-5D-3L), hemorrhoid grade, sex, and center with an automated system to stapled hemorrhoidopexy or traditional excisional surgery. The primary outcome was area under the quality-of-life curve (area under the curve [AUC]) measured with the EQ-5D-3L descriptive system over 24 months, assessed according to the randomized groups. The primary outcome measure was analyzed using linear regression with adjustment for the minimization variables. This trial is registered with the ISRCTN registry, number ISRCTN80061723.

Findings

Between January 13, 2011 and August 1, 2014, 777 patients were randomized (389 to receive stapled hemorrhoidopexy and 388 to receive traditional excisional surgery). Stapled hemorrhoidopexy 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 hemorrhoidopexy 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 hemorrhoidopexy in the first 6 weeks after surgery; the traditional excisional surgery group had significantly better quality-of-life scores than the stapled hemorrhoidopexy group. Twenty-four (7%) of 338 participants who received stapled hemorrhoidopexy and 33 (9%) of 352 participants who received traditional excisional surgery had serious adverse events.

Interpretation

As part of a tailored management plan for hemorrhoids, traditional excisional surgery should be considered over stapled hemorrhoidopexy as the surgical treatment of choice.

Funding

National Institute for Health Research Health Technology Assessment Program.