{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T00:38:22Z","timestamp":1791419902197,"version":"4.3.3"},"reference-count":114,"publisher":"National Institute for Health and Care Research","issue":"88","license":[{"start":{"date-parts":[[2016,11,1]],"date-time":"2016-11-01T00:00:00Z","timestamp":1477958400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["10\/57\/46"],"award-info":[{"award-number":["10\/57\/46"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"Background<\/jats:title>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.<\/jats:p><\/jats:sec>Objective<\/jats:title>The comparison of HAL with RBL for the treatment of grade II\/III haemorrhoids.<\/jats:p><\/jats:sec>Design<\/jats:title>A multicentre, parallel-group randomised controlled trial.<\/jats:p><\/jats:sec>Perspective<\/jats:title>UK NHS and Personal Social Services.<\/jats:p><\/jats:sec>Setting<\/jats:title>17 NHS Trusts.<\/jats:p><\/jats:sec>Participants<\/jats:title>Patients aged \u2265\u200918 years presenting with grade II\/III (second- and third-degree) haemorrhoids, including those who have undergone previous RBL.<\/jats:p><\/jats:sec>Interventions<\/jats:title>HAL with Doppler probe compared with RBL.<\/jats:p><\/jats:sec>Outcomes<\/jats:title>Primary outcome \u2013 recurrence at 1 year post procedure; secondary outcomes \u2013 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.<\/jats:p><\/jats:sec>Results<\/jats:title>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)\u2009=\u20092.23, 95% confidence interval (CI) 1.42 to 3.51;p<\/jats:italic>\u2009=\u20090.0005]. 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<\/jats:italic>\u2009=\u20090.20). 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 \u00a31027 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 \u00a3104,427 per additional QALY.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>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.<\/jats:p><\/jats:sec>Limitations<\/jats:title>Blinding of participants and site staff was not possible.<\/jats:p><\/jats:sec>Future work<\/jats:title>The incidence of recurrence may continue to increase with time. Further follow-up would add to the evidence regarding long-term clinical effectiveness and cost-effectiveness. The polysymptomatic nature of haemorrhoidal disease requires a validated scoring system, and the data from this trial will allow further assessment of validity of such a system. These data add to the literature regarding treatment of grade II\/III haemorrhoids. The results dovetail with results from the eTHoS study [Watson AJM, Hudson J, Wood J, Kilonzo M, Brown SR, McDonald A,et al.<\/jats:italic>Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.Lancet<\/jats:italic>2016, in press.] comparing stapled haemorrhoidectomy with excisional haemorrhoidectomy. Combined results will allow expansion of analysis, allowing surgeons to tailor their treatment options to individual patients.<\/jats:p><\/jats:sec>Trial registration<\/jats:title>Current Controlled Trials ISRCTN41394716.<\/jats:p><\/jats:sec>Funding<\/jats:title>This project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment<\/jats:italic>; Vol. 20, No. 88. See the NIHR Journals Library website for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta20880","type":"journal-article","created":{"date-parts":[[2017,2,1]],"date-time":"2017-02-01T13:46:20Z","timestamp":1485956780000},"page":"1-150","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":68,"title":["The HubBLe Trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for symptomatic second- and third-degree haemorrhoids: a multicentre randomised controlled trial and health-economic evaluation"],"prefix":"10.3310","volume":"20","clinical-trial-number":[{"clinical-trial-number":"isrctn41394716","registry":"10.18810\/isrctn","type":"results"}],"author":[{"given":"Steven","family":"Brown","sequence":"first","affiliation":[{"name":"Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, 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