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

Abstract

SummaryBackgroundOptimum 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.MethodsThis 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.FindingsFrom 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<0·0001). Pain scores did not differ between groups at 21 days and 6 weeks. 15 individuals reported serious adverse events requiring hospital admission. One patient in the RBL group had a pre-existing rectal tumour. Of the remaining 14 serious adverse events, 12 (7%) were among participants treated with HAL and two (1%) were in those treated with RBL. Six patients had pain (one treated with RBL, five treated with HAL), three had bleeding not requiring transfusion (one treated with RBL, two treated with HAL), two in the HAL group had urinary retention, two in the HAL group had vasovagal upset, and one in the HAL group had possible sepsis (treated with antibiotics).Interpr...

A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease: the eTHoS study

“…The findings from the study, along with those from HubBLe and LingaLongo, 16,72 have added greatly to our understanding of the management of haemorrhoids. This study showed better overall generic quality of life over the 24-month follow-up period for TH over SH.…”

“…The trend over a longer period, however, suggested that the greater failure rate for RBL may eventually reach a level that justified the increased cost of SH. More robust data on the outcome of RBL have since come from the HubBLe (haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids) study 16 comparing HAL with RBL, which shows that RBL, when given as a course of two or three treatments, is as clinically effective as HAL.…”

“…Results published in 2016 from the HubBle study suggest that HAL is no better than repeat RBL, which challenges the place of HAL in the modern surgical management of haemorrhoid disease. 16 A recent network meta-analysis of 98 RCTs, which included 7827 patients and 11 surgical treatments for grade III and IV haemorrhoids, compared a number of surgical and clinical outcomes 23 ( Table 1). Patients who had received TH had significantly more postoperative complications than those who had received HAL, LigaSure device and Harmonic scalpel haemorrhoidectomies.…”

“…HSS is not a validated tool; however, it was adopted in the HubBLe study, 16 and at the inception of the eTHoS study it was arguably the best assessment tool available. An initial follow-up period of 24 months for the evaluation of outcomes was used, given the expectation of a trade-off between short-and longer-term outcomes as transpired.…”

A randomized trial found online questionnaires supplemented by postal reminders generated a cost-effective and generalizable sample but don’t forget the reminders

“…The database used by the Sheffield CTRU was developed in-house and is a web-based system that allows remote data entry which can be adapted to allow participants to enter their data directly. To date, the unit has also used the system for this purpose on one randomised trial comparing two procedures for the treatment for haemorrhoids [14] and one observational study of pregnant females with suspected pulmonary embolism [15]. In both cases, participants were asked whether they could be contacted electronically, by post, or either.…”