A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial

摘要

Background: Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) andudstapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical,udquality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is moreudeffective and more cost-effective, compared with TH.ududMethods/Design: eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for HaemorrhoidaludDisease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open toudrecruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part.udThe primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group’s 5udDimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted lifeudyear (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of theudSF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costsudto the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% powerudto detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5Dudscore measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants willudbe randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade ofudhaemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is notudattempted.ududDiscussion: This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidaluddisease are done annually. The trial is therefore designed to give robust evidence on which clinicians and healthudservice managers can base management decisions and, more importantly, patients can make informed choices.ududTrial registration: Current Controlled Trials ISRCTN80061723 (assigned 8 March 2010)