A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.
BACKGROUND
Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH.


METHODS
eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted.


CONCLUSIONS
This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions and, more importantly, patients can make informed choices.


BACKGROUND
Current Controlled Trials ISRCTN80061723 (assigned 8 March 2010).
Department of Surgery, Raigmore Hospital, Old Perth Road, Inverness IV2 3UJ, UK. angus.watson@nhs.net.
Angus J M
AJ
Watson
Hanne
H
Bruhn
Kathleen
K
MacLeod
Alison
A
McDonald
Gladys
G
McPherson
Mary
M
Kilonzo
John
J
Norrie
Malcolm A
MA
Loudon
Kirsty
K
McCormack
Brian
B
Buckley
Steven
S
Brown
Finlay
F
Curran
David
D
Jayne
Ramesh
R
Rajagopal
Jonathan A
JA
Cook
D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D017048:Health Care Costs; D061865:Hemorrhoidectomy / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D006484:Hemorrhoids / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000601:surgery*; D006801:Humans; D011183:Postoperative Complications / Q000209:etiology; D011788:Quality of Life; D012107:Research Design; D017792:Surgical Stapling / Q000009:adverse effects / Q000191:economics; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom