Five-year follow-up of Doppler-guided hemorrhoidal artery ligation

Avital, Shmuel; Inbar, Roy; Karin, Eliad; Greenberg, Ron

doi:10.1007/s10151-011-0801-6

Cited by 47 publications

(27 citation statements)

References 17 publications

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“…We chose to assess recurrence at 12 months because published data suggest that most HAL and RBL recurrences occur within 1 year. 26 Several studies have shown that using HAL for higher-grade haemorrhoids or significant prolapse adversely affects the recurrence rate; 19,37,41,66,67 they also conclude that HAL is perhaps most effective for grade II and early grade III disease. We therefore limited our trial to this most clinically relevant patient population.…”

Section: Main Findingsmentioning

confidence: 99%

“…The substantial data concerning effectiveness include four systematic reviews, 5,19-21 11 randomised controlled trials (RCTs), [22][23][24][25][26][27][28][29][30][31][32] seven non-randomised trials [33][34][35][36][37][38][39] and > 60 case series. An overview has been carried out by the National Institute for Health and Clinical Excellence (NICE), which concludes that current evidence shows it to be a safe alternative to OH or SH; 40 this is summarised below.…”

Section: Introductionmentioning

confidence: 99%

“…The annual probability of recurrence for years 1-3 beyond the trial were estimated from two studies 3,37 that have reported long-term recurrence estimates. For RBL, the annual probability of recurrence was calculated from a retrospective study 3 that reported 4 years' follow-up (n = 805).…”

mentioning

confidence: 99%

“…For RBL, the annual probability of recurrence was calculated from a retrospective study 3 that reported 4 years' follow-up (n = 805). For HAL, the probability of recurrence was calculated at 5-year follow-up in a study 37 that assessed the long-term success rates for treating patients with grade II and III haemorrhoids following Doppler-guided HAL (n = 100). 37 The mean total costs over four years, per patient, within each group (HAL and RBL) were calculated based on the annual probabilities of transition between health states.…”

mentioning

confidence: 99%

“…For HAL, the probability of recurrence was calculated at 5-year follow-up in a study 37 that assessed the long-term success rates for treating patients with grade II and III haemorrhoids following Doppler-guided HAL (n = 100). 37 The mean total costs over four years, per patient, within each group (HAL and RBL) were calculated based on the annual probabilities of transition between health states. The mean total QALYs over the same period were similarly estimated and adjusted for recurrence.…”

mentioning

confidence: 99%

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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

Brown

Tiernan

Biggs

et al. 2016

Health Technol Assess

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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.

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Section: Main Findingsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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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

Brown

Tiernan

Biggs

et al. 2016

Health Technol Assess

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Updates of surgical treatment in hemorrhoidal disease

Li,

Ma,

Wang

et al. 2024

Advanced Chinese Medicine

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Hemorrhoidal disease is one of the most prevalent and frequently occurring conditions worldwide. Treatment modalities for hemorrhoids are multifaceted and tailored according to the severity of the condition. Various surgical procedures and modified approaches had been invented since 1937. Here we review the workflow, advantages, and disadvantages of different types of hemorrhoid surgery (conventional excisional hemorrhoidectomy, modified excisional surgery, stapled/partial stapled hemorrhoidopexy, and Doppler‐guided hemorrhoidal artery ligation). There is no single treatment that fits all hemorrhoid patients. Surgeons should make the operation plan based on patients' conditions and wills.

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