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The HubBle trial: Haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for symptomatic second- and third-degree haemorrhoids: A multicentre randomized controlled trial and health-economic evaluation

The HubBle trial: Haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for symptomatic second- and third-degree haemorrhoids: A multicentre randomized controlled trial and health-economic evaluation
The HubBle trial: Haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for symptomatic second- and third-degree haemorrhoids: A multicentre randomized controlled trial and health-economic evaluation

Background: Optimal surgical intervention for low-grade haemorrhoids is unknown. Rubber band ligation (RBL) is probably the most common intervention. Haemorrhoidal artery ligation (HAL) is a novel alternative that may be more efficacious. Objective: The comparison of HAL with RBL for the treatment of grade II/III haemorrhoids. 

Design: A multicentre, parallel-group randomised controlled trial. Perspective: UK NHS and Personal Social Services. Setting: 17 NHS Trusts. 

Participants: Patients aged ≥ 18 years presenting with grade II/III (second-and third-degree) haemorrhoids, including those who have undergone previous RBL. Interventions: HAL with Doppler probe compared with RBL. 

Outcomes: Primary outcome-recurrence at 1 year post procedure; secondary outcomes-recurrence at 6 weeks; haemorrhoid severity score; European Quality of Life-5 Dimensions, 5-level version (EQ-5D-5L); Vaizey incontinence score; pain assessment; complications; and cost-effectiveness. 

Results: A total of 370 participants entered the trial. At 1 year post procedure, 30% of the HAL group had evidence of recurrence compared with 49% after RBL [adjusted odds ratio (OR) = 2.23, 95% confidence interval (CI) 1.42 to 3.51; p = 0.0005]. The main reason for the difference was the number of extra procedures required to achieve improvement/cure. If a single HAL is compared with multiple RBLs then only 37.5% recurred in the RBL arm (adjusted OR 1.35, 95% CI 0.85 to 2.15; p = 0.20). Persistence of significant symptoms at 6 weeks was lower in both arms than at 1 year (9% HAL and 29% RBL), suggesting significant deterioration in both groups over the year. Symptom score, EQ-5D-5L and Vaizey score improved in both groups compared with baseline, but there was no difference between interventions. Pain was less severe and of shorter duration in the RBL group; most of the HAL group who had pain had mild to moderate pain, resolving by 3 weeks. Complications were low frequency and not significantly different between groups. It appeared that HAL was not cost-effective compared with RBL. In the base-case analysis, the difference in mean total costs was £1027 higher for HAL. Quality-adjusted life-years (QALYs) were higher for HAL; however, the difference was very small (0.01) resulting in an incremental cost-effectiveness ratio of £104,427 per additional QALY. 

Conclusions: At 1 year, although HAL resulted in fewer recurrences, recurrence was similar to repeat RBL. Symptom scores, complications, EQ-5D-5L and continence score were no different, and patients had more pain in the early postoperative period after HAL. HAL is more expensive and unlikely to be cost-effective in terms of incremental cost per QALY.

1366-5278
1-180
Brown, Steven
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Tiernan, Jim
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Biggs, Katie
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Hind, Daniel
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Shephard, Neil
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Bradburn, Mike
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Wailoo, Allan
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Alshreef, Abualbishr
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Swaby, Lizzie
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Watson, Angus
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Radley, Simon
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Jones, Oliver
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Skaife, Paul
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Agarwal, Anil
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Giordano, Pasquale
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Lamah, Marc
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Cartmell, Mark
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Davies, Justin
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Faiz, Omar
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Nugent, Karen
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Clarke, Andrew
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Macdonald, Angus
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Conaghan, Phillip
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Ziprin, Paul
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Makhija, Rohit
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Brown, Steven
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Tiernan, Jim
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Biggs, Katie
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Hind, Daniel
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Shephard, Neil
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Bradburn, Mike
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Wailoo, Allan
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Alshreef, Abualbishr
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Swaby, Lizzie
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Watson, Angus
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Radley, Simon
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Jones, Oliver
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Skaife, Paul
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Agarwal, Anil
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Lamah, Marc
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Cartmell, Mark
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Davies, Justin
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Faiz, Omar
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Nugent, Karen
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Clarke, Andrew
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Macdonald, Angus
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Conaghan, Phillip
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Ziprin, Paul
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Makhija, Rohit
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Brown, Steven, Tiernan, Jim, Biggs, Katie, Hind, Daniel, Shephard, Neil, Bradburn, Mike, Wailoo, Allan, Alshreef, Abualbishr, Swaby, Lizzie, Watson, Angus, Radley, Simon, Jones, Oliver, Skaife, Paul, Agarwal, Anil, Giordano, Pasquale, Lamah, Marc, Cartmell, Mark, Davies, Justin, Faiz, Omar, Nugent, Karen, Clarke, Andrew, Macdonald, Angus, Conaghan, Phillip, Ziprin, Paul and Makhija, Rohit (2016) The HubBle trial: Haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for symptomatic second- and third-degree haemorrhoids: A multicentre randomized controlled trial and health-economic evaluation. Health Technology Assessment, 20 (88), 1-180. (doi:10.3310/hta20880).

Record type: Article

Abstract

Background: Optimal surgical intervention for low-grade haemorrhoids is unknown. Rubber band ligation (RBL) is probably the most common intervention. Haemorrhoidal artery ligation (HAL) is a novel alternative that may be more efficacious. Objective: The comparison of HAL with RBL for the treatment of grade II/III haemorrhoids. 

Design: A multicentre, parallel-group randomised controlled trial. Perspective: UK NHS and Personal Social Services. Setting: 17 NHS Trusts. 

Participants: Patients aged ≥ 18 years presenting with grade II/III (second-and third-degree) haemorrhoids, including those who have undergone previous RBL. Interventions: HAL with Doppler probe compared with RBL. 

Outcomes: Primary outcome-recurrence at 1 year post procedure; secondary outcomes-recurrence at 6 weeks; haemorrhoid severity score; European Quality of Life-5 Dimensions, 5-level version (EQ-5D-5L); Vaizey incontinence score; pain assessment; complications; and cost-effectiveness. 

Results: A total of 370 participants entered the trial. At 1 year post procedure, 30% of the HAL group had evidence of recurrence compared with 49% after RBL [adjusted odds ratio (OR) = 2.23, 95% confidence interval (CI) 1.42 to 3.51; p = 0.0005]. The main reason for the difference was the number of extra procedures required to achieve improvement/cure. If a single HAL is compared with multiple RBLs then only 37.5% recurred in the RBL arm (adjusted OR 1.35, 95% CI 0.85 to 2.15; p = 0.20). Persistence of significant symptoms at 6 weeks was lower in both arms than at 1 year (9% HAL and 29% RBL), suggesting significant deterioration in both groups over the year. Symptom score, EQ-5D-5L and Vaizey score improved in both groups compared with baseline, but there was no difference between interventions. Pain was less severe and of shorter duration in the RBL group; most of the HAL group who had pain had mild to moderate pain, resolving by 3 weeks. Complications were low frequency and not significantly different between groups. It appeared that HAL was not cost-effective compared with RBL. In the base-case analysis, the difference in mean total costs was £1027 higher for HAL. Quality-adjusted life-years (QALYs) were higher for HAL; however, the difference was very small (0.01) resulting in an incremental cost-effectiveness ratio of £104,427 per additional QALY. 

Conclusions: At 1 year, although HAL resulted in fewer recurrences, recurrence was similar to repeat RBL. Symptom scores, complications, EQ-5D-5L and continence score were no different, and patients had more pain in the early postoperative period after HAL. HAL is more expensive and unlikely to be cost-effective in terms of incremental cost per QALY.

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Published date: 1 January 2016

Identifiers

Local EPrints ID: 445118
URI: http://eprints.soton.ac.uk/id/eprint/445118
ISSN: 1366-5278
PURE UUID: 47a85572-b76d-4ba8-a4f2-f85c4ec95183

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Date deposited: 19 Nov 2020 17:33
Last modified: 08 Jan 2022 14:14

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Contributors

Author: Steven Brown
Author: Jim Tiernan
Author: Katie Biggs
Author: Daniel Hind
Author: Neil Shephard
Author: Mike Bradburn
Author: Allan Wailoo
Author: Abualbishr Alshreef
Author: Lizzie Swaby
Author: Angus Watson
Author: Simon Radley
Author: Oliver Jones
Author: Paul Skaife
Author: Anil Agarwal
Author: Pasquale Giordano
Author: Marc Lamah
Author: Mark Cartmell
Author: Justin Davies
Author: Omar Faiz
Author: Karen Nugent
Author: Andrew Clarke
Author: Angus Macdonald
Author: Phillip Conaghan
Author: Paul Ziprin
Author: Rohit Makhija

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