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

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).

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.

This record has no associated files available for download.

Contributors

Download statistics