Scores values tended to decrease postoperatively .
The comparison between haemorrhoidal treatments is still unclear .
Attempts have been made to adopt a unifying postoperative scoring system and thus ensure adequate comparison between clinical trials .
We aim ed to systematic ally review the available outcome scores of haemorrhoidal treatment .
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.
BACKGROUND Optimal surgical intervention for low- grade haemorrhoids is unknown . Rubber b and 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 r and omised 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 ) result ing in an incremental cost-effectiveness ratio of £ 104,427 per additional QALY . CONCLUSIONS At 1 year , although HAL result ed 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 . LIMITATIONS Blinding of participants and site staff was not possible . FUTURE WORK 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 vali date d 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 , r and omised controlled trial . Lancet 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 . TRIAL REGISTRATION Current Controlled Trials IS RCT N41394716 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 20 , No. 88 . See the NIHR Journals Library website for further project information
Scores values tended to decrease postoperatively .
The comparison between haemorrhoidal treatments is still unclear .
Attempts have been made to adopt a unifying postoperative scoring system and thus ensure adequate comparison between clinical trials .
We aim ed to systematic ally review the available outcome scores of haemorrhoidal treatment .