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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 AJ, Bruhn H, MacLeod K, McDonald A, McPherson G, Kilonzo M, Norrie J, Loudon MA, McCormack K, Buckley B, Brown S, Curran F, Jayne D, Rajagopal R, Cook JA, eTHoS study gro - Trials (2014)

Bottom Line: 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%.Blinding of participants and outcome assessors is not attempted.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Raigmore Hospital, Old Perth Road, Inverness IV2 3UJ, UK. angus.watson@nhs.net.

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/design: 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.

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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Related in: MedlinePlus

Flow diagram of the eTHoS trial. EQ-5D, European Quality of Life 3 Dimensions; VAS, visual analogue scale; SF36, Short Form (36) Health Survey.
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Related In: Results  -  Collection

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Fig1: Flow diagram of the eTHoS trial. EQ-5D, European Quality of Life 3 Dimensions; VAS, visual analogue scale; SF36, Short Form (36) Health Survey.

Mentions: See FigureĀ 1 for an overview of the trial.Figure 1


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 AJ, Bruhn H, MacLeod K, McDonald A, McPherson G, Kilonzo M, Norrie J, Loudon MA, McCormack K, Buckley B, Brown S, Curran F, Jayne D, Rajagopal R, Cook JA, eTHoS study gro - Trials (2014)

Flow diagram of the eTHoS trial. EQ-5D, European Quality of Life 3 Dimensions; VAS, visual analogue scale; SF36, Short Form (36) Health Survey.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4289313&req=5

Fig1: Flow diagram of the eTHoS trial. EQ-5D, European Quality of Life 3 Dimensions; VAS, visual analogue scale; SF36, Short Form (36) Health Survey.
Mentions: See FigureĀ 1 for an overview of the trial.Figure 1

Bottom Line: 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%.Blinding of participants and outcome assessors is not attempted.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Raigmore Hospital, Old Perth Road, Inverness IV2 3UJ, UK. angus.watson@nhs.net.

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/design: 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.

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).

Show MeSH
Related in: MedlinePlus