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Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial

Brown, Steven R.; Tiernan, James P.; Watson, Angus J.M.; Biggs, Katie; Shephard, Neil; Wailoo, Allan J.; Bradburn, Mike; Alshreef, Abualbishr; Hind, Daniel

Authors

Steven R. Brown

James P. Tiernan

Angus J.M. Watson

Katie Biggs

Neil Shephard

Allan J. Wailoo

Mike Bradburn

Abualbishr Alshreef

Daniel Hind



Abstract

Background

Optimum surgical intervention for low-grade haemorrhoids is unknown. Haemorrhoidal artery ligation (HAL) has been proposed as an efficacious, safe therapy while rubber band ligation (RBL) is a commonly used outpatient treatment. We compared recurrence after HAL versus RBL in patients with grade II–III haemorrhoids.

Methods

This multicentre, open-label, parallel group, randomised controlled trial included patients from 17 acute UK NHS trusts. We screened patients aged 18 years or older presenting with grade II–III haemorrhoids. We excluded patients who had previously received any haemorrhoid surgery, more than one injection treatment for haemorrhoids, or more than one RBL procedure within 3 years before recruitment. Eligible patients were randomly assigned (in a 1:1 ratio) to either RBL or HAL with Doppler. Randomisation was computer-generated and stratified by centre with blocks of random sizes. Allocation concealment was achieved using a web-based system. The study was open-label with no masking of participants, clinicians, or research staff. The primary outcome was recurrence at 1 year, derived from the patient's self-reported assessment in combination with resource use from their general practitioner and hospital records. Recurrence was analysed in patients who had undergone one of the interventions and been followed up for at least 1 year. This study is registered with the ISRCTN registry, ISRCTN41394716.

Findings

From Sept 9, 2012, to May 6, 2014, of 969 patients screened, 185 were randomly assigned to the HAL group and 187 to the RBL group. Of these participants, 337 had primary outcome data (176 in the RBL group and 161 in the HAL group). At 1 year post-procedure, 87 (49%) of 176 patients in the RBL group and 48 (30%) of 161 patients in the HAL group had haemorrhoid recurrence (adjusted odds ratio [aOR] 2·23, 95% CI 1·42–3·51; p=0·0005). The main reason for this difference was the number of extra procedures required to achieve improvement (57 [32%] participants in the RBL group and 23 [14%] participants in the HAL group had a subsequent procedure for haemorrhoids). The mean pain 1 day after procedure was 3·4 (SD 2·8) in the RBL group and 4·6 (2·8) in the HAL group (difference −1·2, 95% CI −1·8 to −0·5; p=0·0002); at day 7 the scores were 1·6 (2·3) in the RBL group and 3·1 (2·4) in the HAL group (difference −1·5, −2·0 to −1·0; p

Citation

Brown, S. R., Tiernan, J. P., Watson, A. J., Biggs, K., Shephard, N., Wailoo, A. J., …Hind, D. (2016). Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. Lancet, 388(10042), 356-364. https://doi.org/10.1016/S0140-6736%2816%2930584-0

Journal Article Type Article
Acceptance Date May 25, 2016
Publication Date Jul 21, 2016
Deposit Date Jan 31, 2017
Publicly Available Date Mar 28, 2024
Journal The Lancet
Print ISSN 0140-6736
Electronic ISSN 1474-547X
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 388
Issue 10042
Pages 356-364
DOI https://doi.org/10.1016/S0140-6736%2816%2930584-0
Public URL https://nottingham-repository.worktribe.com/output/799897
Publisher URL http://dx.doi.org/10.1016/S0140-6736(16)30584-0
Additional Information This article is maintained by: Elsevier; Article Title: Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial; Journal Title: The Lancet; CrossRef DOI link to publisher maintained version: https://doi.org/10.1016/S0140-6736(16)30584-0; CrossRef DOI link to the associated document: https://doi.org/10.1016/S0140-6736(16)30657-2; Content Type: article; Copyright: © 2016 The Author(s). Published by Elsevier Ltd.

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