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

Abstract

BackgroundOptimal 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.ObjectiveThe comparison of HAL with RBL for the treatment of grade II/III haemorrhoids.DesignA multicentre, parallel-group randomised controlled trial.PerspectiveUK NHS and Personal Social Services.Setting17 NHS Trusts.ParticipantsPatients aged ≥ 18 years presenting with grade II/III (second- and third-degree) haemorrhoids, including those who have undergone previous RBL.InterventionsHAL with Doppler probe compared with RBL.OutcomesPrimary 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.ResultsA 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.ConclusionsAt 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.LimitationsBlinding of participants and site staff was not possible.Future workThe 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.Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.Lancet2016, 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.Trial registrationCurrent Controlled Trials ISRCTN41394716.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 88. See the NIHR Journals Library website for further project information.

Surgical management of haemorrhoids: an Italian survey of over 32 000 patients over 17 years

“…This trend is confirmed by the predicted probability model where the OR of performing DGHAL or non-DGHAL instead of RBL has moderately but significantly increased. These data are in disagreement with the conclusions of a recent RCT that compares RBL to DGHAL [11] and shows that, at 1 year of follow-up, haemorrhoid recurrence after DGHAL was similar to repeated RBL. Furthermore, in this trial, patients had more postoperative pain after DGHAL which was also more expensive and less cost-effective.…”

“…Nevertheless, their long-term outcome needs to be confirmed by further studies. In fact, the reported long-term outcome in terms of recurrences after these operations widely varies from 9.5% in large case series [26] to 30% in RCT [11]. The results of this survey indicate that today haemorrhoids management in Italy is aligned to the recently published Italian position paper 27 and to most of the international guidelines [6][7][8][9]27].…”

“…For about 10 years after the introduction of this new device, stapler haemorrhoidopexy has been the second most practiced surgical technique to treat III-degree haemorrhoids in Italy (32% of patients evaluated in this 10-years survey). After that period, its use fell relates to an increased awareness of the long-term recurrence rate of the procedure as described in recent publications [10,11,19].…”

Results of the double-blind randomized controlled trial comparing laser hemorrhoidoplasty with sutured mucopexy and excisional hemorrhoidectomy

“…The most effective procedure-excisional hemorrhoidectomy-causes the most pain to the patient [1]. Two recent large randomized trials compared excisional hemorrhoidectomy with stapled hemorrhoidopexy [2], and rubber band ligation with hemorrhoidal artery ligation [3]. The first trial conclusively proved that excisional hemorrhoidectomy is more effective and cheaper than stapled hemorrhoidopexy.…”

Haemorrhoids: piling on the agony

“…Most centres favour rubber band ligation, which is generally quite efficacious and has similar outcomes to more invasive procedures, especially after repeat banding. 8 At the time of proctoscopy (or flexible sigmoidoscopy) an assessment is made of the size of haemorrhoids and the largest one is usually banded with a rubber band. This constricts the blood flow to the haemorrhoid, which sloughs off after about 10-14 days.…”