eTHoS: eiTher Haemmorrhoidectomy or Stapled haemmorrhoidopexy for haemmorrhoidal disease: a pragmatic multi-centre randomised controlled trial comparing stapled haemorrhoidopexy to conventional excisional haemorrhoidectomy
Haemorrhoids are common in all age groups from mid-teens onwards. In England in 2006/2007, approximately 25,000 haemorrhoidal procedures were performed as hospital day-case or inpatient admissions, placing a significant burden on health service resources. Stapled haemorrhoidopexy (SH) offers a new alternative to traditional haemorrhoidectomy (TH). There have been multiple randomised controlled trials (RCTs) comparing SH with TH and these have been analysed in two recent systematic reviews and an HTA monograph. SH appears to be associated with less pain in the immediate post-operative period, but a higher rate of recurrence in the longer term and need for further surgery. However, these findings are based on data from small trials, all with methodological flaws and providing limited data on utilities in the early post-operative period. The eTHoS RCT is comparing SH with CH. The primary outcomes are: (1) Health-related quality-of-life profile derived from the EQ–5D; (2) Incremental cost per quality-adjusted life year (QALY) at two years. Participants have now been followed up to two years. The results of the trial are currently being disseminated through peer reviewed publications and other activities. The trial results will guide NHS decision making on the optimal approach to the surgical management of haemorrhoids.
Outcome and translation
The trial results indicated that TH is both more clinically effective and less costly when compared with SH. It is more painful in the short term, but return to normal activity rates are equal. In addition to superior quality of life measures, haemorrhoid symptoms scores, continence and tenesmus rates and the need for further surgery were all lower in TH. TH is, therefore, a superior surgical treatment for the management of grades II to IV haemorrhoids when compared with SH. Given the current financial status of the NHS, commissioners of healthcare may consider being more prescriptive about procedures being offered for haemorrhoids.
HERU researchers involved in this research project: Mary Kilonzo
External collaborators: AJ Watson (NHS Highland); M Loudon (Aberdeen Royal Infirmary); L Vale (University of Newcastle); D Jayne (Leeds Teaching Hospitals NHS Trust); A Maw (Glan Clwyd Hospital); F Curran (Stepping Hill Hospital); S Brown (Northern General Hospital); J Cook, J Norrie (HSRU, University of Aberdeen); J Burr (University of St. Andrews) and B Buckley (National University of Ireland)
International Standard Randomised Controlled Trial Number Register: ISRCTN80061723
The National Institute for Health Research (NIHR) have produced an NIHR Signal for this research project.
Watson, A., Bruhn, H., MacLeod, K., McDonald, A., McPherson, G., Kilonzo, M., Norrie, J., Loudon, M., McCormack, K., Buckley, B., Brown, S., Curran, F., Jayne, D., Rajagopal, R. and Cook, J. (2014) 'A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial' [Protocol], Trials, 15, 439.
Watson, A. J., Hudson, J., Wood, J., Kilonzo, M., Brown, S. R., McDonald, A., Norrie, J., Bruhn, H. and Cook, J. A. (2016) 'Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial', Lancet, 388(10058), 2375-2385.
Watson, A. J., Cook, J., Hudson, J., Kilonzo, M., Wood, J., Bruhn, H., Brown, S., Buckley, B., Curran, F., Jayne, D., Loudon, M., Rajagopal, R., McDonald, A. and Norrie, J. (2016) A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease: the eTHoS Study. Final report submitted to the National Institute for Health Research (NIHR) Health Technology Assessment Programme.
Kilonzo, M., Brown, S.R., Bruhn, H., Cook, J.A., Hudson, J., Norrie, J., Watson, A.J.M. and Wood, J. (2017) 'Cost effectiveness of stapled haemorrhoidopexy and traditional excisional surgery for the treatment of haemorrhoidal disease', PharmacoEconomics - Open.
Watson, A.J., Cook, J., Hudson, J., Kilonzo, M., Wood, J., Bruhn, H., Brown, S., Buckley, B., Curran, F., Jayne, D., Loudon, M., Rajagopal, R., McDonald, A. and Norrie, J. (2017) 'A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease: the eTHoS study', Health Technology Assessment, 21(70).