Short-Term and Long-Term Results of Combined Sclerotherapy and Rubber Band Ligation of Hemorrhoids and Mucosal Prolapse

Chew, Simon S. B.; Marshall, Lynne; Kalish, Larry; Tham, Jui; Grieve, David A.; Douglas, P. R.; Newstead, Graham L.

doi:10.1007/s10350-004-6720-0

Cited by 57 publications

(33 citation statements)

References 16 publications

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“…Combination of RBL and injection sclerotherapy has been suggested as a more effective method of treatment than RBL alone, 111,112 but remains unproven in a well-designed trial.…”

Section: Rubber Band Ligationmentioning

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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“…Combination of RBL and injection sclerotherapy has been suggested as a more effective method of treatment than RBL alone, 111,112 but remains unproven in a well-designed trial.…”

Section: Rubber Band Ligationmentioning

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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“…Sclerotherapy has also been used for a long time, but has been found to be inferior to rubber band ligation in terms of the response to treatment and recurrence rate. 16 Many sclerotic agents have been used until now. The agents lead to the necrosis of hemorrhoid tissue, thus causing moderate tissue destruction with scarring and subsequent fi xation of the submucosa.…”

Section: Discussionmentioning

confidence: 99%

“…We routinely performed the procedure in the three classic positions, namely, the right anterior, right posterior, and left lateral, modifi ed in a small proportion of patients as clinically indicated. 16 According to the protocol, additional second sclerotherapy was administered to the patients who did not benefi t from the fi rst sclerotherapy. The second sclerotherapy was performed 4 weeks after the fi rst administration.…”

Section: Study Design and Participantsmentioning

confidence: 99%

Conservative management of hemorrhoids: A comparison of venotonic flavonoid micronized purified flavonoid fraction (MPFF) and sclerotherapy

et al. 2008

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“…Bei der Stuhlentleerung prolabierende Hämor-rhoidalknoten, die noch eine Spontanretraktion zeigen (⊡ Abb. 6), werden stadiengerecht mittels Gummiringligatur nach Barron [3] therapiert [1,9]. Ein kleiner Gummiring, der mittels Applikator oberhalb des sensiblen Anoderms über den Hämorrhoidalknoten gestülpt wird, bewirkt eine Nekrose des erfassten Gewebes.Nach 3-5 Tagen erfolgt die Abstoßung häufig in Verbindung mit einer leichten Blutung.Eine schwere,ggf.lebensbedrohliche, arterielle Blutung aus dem verbliebenen Ulkus wird innerhalb von 21 Tagen nach diesem Eingriff in 0,5% (-5%) der Fälle angegeben [13,27].…”

Section: Hämorrhoiden Ii°gunclassified

“…5 ▲ Hämorrhoiden I°Abb. 9 Die Langzeitergebnisse sind hervorragend bei niedrigsten Rezidivraten [27].…”

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H�morrhoiden

2004

Der Hautarzt

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Hemorrhoidal disease results from the pathological enlargement and distal displacement of the upper hemorrhoidal plexus. This disorder is very widespread in modern industrial society. Hereditary predisposition, malnutrition with constipation and abnormal bowel habits seem to be the most relevant causes for pathogenesis. The exact classification of hemorrhoids according to the degree of prolapse as well as the correct evaluation of accompanying anal diseases are very important in order to choose the appropriate conservative or surgical treatment with the goal of long-term avoidance of recurrence.

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Short-Term and Long-Term Results of Combined Sclerotherapy and Rubber Band Ligation of Hemorrhoids and Mucosal Prolapse

Abstract: Combined triple sclerotherapy and rubber band ligation is an effective treatment for early hemorrhoids and incomplete mucosal prolapse, with low rates of recurrence, complications, and hemorrhoidectomy, and it can be repeated easily.

Cited by 57 publications

References 16 publications

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

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

Conservative management of hemorrhoids: A comparison of venotonic flavonoid micronized purified flavonoid fraction (MPFF) and sclerotherapy

H�morrhoiden

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