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

study protocol for a randomised controlled trial

Angus J M Watson, Hanne Bruhn, Kathleen MacLeod, Alison McDonald, Gladys McPherson, Mary Kilonzo, John Norrie, Malcolm A Loudon, Kirsty McCormack, Brian Buckley, Steven Brown, Finlay Curran, David Jayne, Ramesh Rajagopal, Jonathan A Cook

Research output: Contribution to journalArticle

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Abstract

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 outcomes include QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and economic, 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 quality of life 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.

DISCUSSION: 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.Trial registration: Current Controlled Trials ISRCTN80061723 (assigned 8 March 2010).

Original languageEnglish
Article number439
JournalTrials
Volume15
DOIs
Publication statusPublished - 11 Nov 2014

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Hemorrhoidectomy
Randomized Controlled Trials
Quality of Life
Costs and Cost Analysis
Area Under Curve
Secondary Care Centers
Economics
Hemorrhoids
Quality-Adjusted Life Years
National Health Programs
Random Allocation
Sample Size
Health Status
Uncertainty
Health Services
Recurrence
Pain

Keywords

  • haemorrhoids
  • stapled haemorrhoidopexy
  • excisional haemorrhoidectomy
  • haemorrhoid artery ligation
  • randomised controlled trials
  • discrete choice experiment
  • health economics
  • anorectal surgery
  • trial incentives

Cite this

A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS) : study protocol for a randomised controlled trial. / Watson, Angus J M; Bruhn, Hanne; MacLeod, Kathleen; McDonald, Alison; McPherson, Gladys; Kilonzo, Mary; Norrie, John; Loudon, Malcolm A; McCormack, Kirsty; Buckley, Brian; Brown, Steven; Curran, Finlay; Jayne, David; Rajagopal, Ramesh; Cook, Jonathan A.

In: Trials, Vol. 15, 439, 11.11.2014.

Research output: Contribution to journalArticle

Watson, Angus J M ; Bruhn, Hanne ; MacLeod, Kathleen ; McDonald, Alison ; McPherson, Gladys ; Kilonzo, Mary ; Norrie, John ; Loudon, Malcolm A ; McCormack, Kirsty ; Buckley, Brian ; Brown, Steven ; Curran, Finlay ; Jayne, David ; Rajagopal, Ramesh ; Cook, Jonathan A. / A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS) : study protocol for a randomised controlled trial. In: Trials. 2014 ; Vol. 15.
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abstract = "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 outcomes include QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and economic, 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 quality of life 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.DISCUSSION: 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.Trial registration: Current Controlled Trials ISRCTN80061723 (assigned 8 March 2010).",
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note = "The authors would like to thank all participants for their involvement in the study and all the principal investigators and their teams at each of the eTHoS sites (the eTHoS trial collaborators) and Jennifer Burr who contributed at the design phase. Thanks are also due to Andrew Elders, trial statistician until June 2014. The study is supported by a grant from the National Institute for Health Research (NIHR), Health Technology Assessment (HTA) Programme - Project Number 08/24/02. The Health Services Research Unit of the University of Aberdeen is funded in part by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Chief Scientist Office, HTA programme, NIHR, NHS or Department of Health. JAC held a MRC Medical Research Council UK training (reference no. G0601938) and methodology (reference no. G1002292) fellowships while this research was undertaken. The funders had no involvement in study design, collection, analysis and interpretation of data, reporting or the decision to publish.",
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T1 - A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS)

T2 - study protocol for a randomised controlled trial

AU - Watson, Angus J M

AU - Bruhn, Hanne

AU - MacLeod, Kathleen

AU - McDonald, Alison

AU - McPherson, Gladys

AU - Kilonzo, Mary

AU - Norrie, John

AU - Loudon, Malcolm A

AU - McCormack, Kirsty

AU - Buckley, Brian

AU - Brown, Steven

AU - Curran, Finlay

AU - Jayne, David

AU - Rajagopal, Ramesh

AU - Cook, Jonathan A

N1 - The authors would like to thank all participants for their involvement in the study and all the principal investigators and their teams at each of the eTHoS sites (the eTHoS trial collaborators) and Jennifer Burr who contributed at the design phase. Thanks are also due to Andrew Elders, trial statistician until June 2014. The study is supported by a grant from the National Institute for Health Research (NIHR), Health Technology Assessment (HTA) Programme - Project Number 08/24/02. The Health Services Research Unit of the University of Aberdeen is funded in part by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Chief Scientist Office, HTA programme, NIHR, NHS or Department of Health. JAC held a MRC Medical Research Council UK training (reference no. G0601938) and methodology (reference no. G1002292) fellowships while this research was undertaken. The funders had no involvement in study design, collection, analysis and interpretation of data, reporting or the decision to publish.

PY - 2014/11/11

Y1 - 2014/11/11

N2 - 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 outcomes include QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and economic, 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 quality of life 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.DISCUSSION: 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.Trial registration: Current Controlled Trials ISRCTN80061723 (assigned 8 March 2010).

AB - 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 outcomes include QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and economic, 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 quality of life 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.DISCUSSION: 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.Trial registration: Current Controlled Trials ISRCTN80061723 (assigned 8 March 2010).

KW - haemorrhoids

KW - stapled haemorrhoidopexy

KW - excisional haemorrhoidectomy

KW - haemorrhoid artery ligation

KW - randomised controlled trials

KW - discrete choice experiment

KW - health economics

KW - anorectal surgery

KW - trial incentives

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DO - 10.1186/1745-6215-15-439

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VL - 15

JO - Trials

JF - Trials

SN - 1745-6215

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ER -