Doppler‐guided haemorrhoidal artery ligation, rectoanal repair, sutured haemorrhoidopexy and minimal mucocutaneous excision for grades III–IV haemorrhoids: a multicenter prospective study of safety and efficacy

Theodoropoulos, George; Sevrisarianos, N.; Papaconstantinou, John; Panoussopoulos, Sotirios G.; Dardamanis, Dimitrios; Stamopoulos, Paraskevas; Bramis, Konstantinos; Spiliotis, John; Datsis, A.; Leandros, Emmanuel

doi:10.1111/j.1463-1318.2008.01739.x

Cited by 70 publications

(49 citation statements)

References 43 publications

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“…This in turn facilitates the shrinkage of the piles, reduction in the prolapse and alleviation of symptoms. Since 1995, THD has been evaluated in many case series [1,4,[22][23][24][25][26][27][28][29][30][31][32][33] and three randomised controlled trials [34][35][36]. Currently, both PPH and THD are being investigated quite extensively to evaluate their clinical success to treat HD in terms of postoperative pain, relief of symptoms and recurrence rate.…”

Section: Introductionmentioning

confidence: 99%

A systematic review comparing transanal haemorrhoidal de-arterialisation to stapled haemorrhoidopexy in the management of haemorrhoidal disease

et al. 2011

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Both THD and SH are equally effective and can be attempted for the management of HD. However, THD is associated with significantly lesser postoperative pain and therefore may be considered a preferred procedure. This conclusion is based only on treating 150 patients by THD or SH in three moderate-quality randomised trials. A major, multicenter, randomised trial is required to validate this conclusion and investigate other variables like hospital stay, cost-effectiveness and health-related quality of life measurement.

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Section: Introductionmentioning

confidence: 99%

A systematic review comparing transanal haemorrhoidal de-arterialisation to stapled haemorrhoidopexy in the management of haemorrhoidal disease

et al. 2011

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“…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 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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“…These procedures include ''recto anal repair (RAR)'' [5], ''transanal hemorrhoid mucopexy'' [6], ''anal lifting'' [7], or ''hemorrhoidal fixation technique.' ' The HAL method requires the use of a proctoscope with a Doppler transducer attached.…”

Section: Introductionmentioning

confidence: 99%

Doppler-guided hemorrhoidal artery ligation does not offer any advantage over suture ligation of grade 3 symptomatic hemorrhoids

et al. 2011

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Doppler‐guided haemorrhoidal artery ligation, rectoanal repair, sutured haemorrhoidopexy and minimal mucocutaneous excision for grades III–IV haemorrhoids: a multicenter prospective study of safety and efficacy

Abstract: DGHAL with the selective application of SHP/RAR is a safe and effective technique for advanced grade HR.

Cited by 70 publications

References 43 publications

A systematic review comparing transanal haemorrhoidal de-arterialisation to stapled haemorrhoidopexy in the management of haemorrhoidal disease

A systematic review comparing transanal haemorrhoidal de-arterialisation to stapled haemorrhoidopexy in the management of haemorrhoidal disease

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

Doppler-guided hemorrhoidal artery ligation does not offer any advantage over suture ligation of grade 3 symptomatic hemorrhoids

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