A comparison of the simultaneous application of sclerotherapy and rubber band ligation, with sclerotherapy and rubber band ligation applied separately, for the treatment of haemorrhoids: a prospective randomized trial

Kanellos, Ioannis; Goulimaris, I.; Christoforidis, E.; Kelpis, Timotheos G.; Betsis, D.

doi:10.1046/j.1463-1318.2003.00395.x

Cited by 56 publications

(34 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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“…Kanellos reported higher percentages of minor complications (46% of recurrence for bleeding and 34% for prolapses in II degree hemorrhoids) (14). Recurrence rates following RBL are shown in Table 4.…”

Section: Resultsmentioning

confidence: 97%

“…IRC (14)(15)(16)(17): The average age of patient managed with IRC in the analyzed studies was 45. 56.6% of patients were males.…”

Section: Resultsmentioning

confidence: 99%

“…Post-operative bleeding is reported in up to 50% of patients in the RCT proposed by Ramzisham, however lower rates are presented in others RCTs (Table 2) (11). Recurrences of bleeding and prolapse at follow-up occurr respectively in 10%-18% (7,9,11,25) and in 2.2% of patients (25); Kanellos reported higher percentages of minor complications (46% of recurrence for bleeding and 34% for prolapses in II degree hemorrhoids) (14). Zaher investigated the use of RBL in patients with portal hypertension comparing it to hemorrhoidopexy, showing similar results in success rate, post-operative pain and bleeding, and recurrences; RBL seems a good treatment in these patients suffering internal hemorrhoids and without coagulation disorders (22).…”

Section: Discussionmentioning

confidence: 99%

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The non-surgical management for hemorrhoidal disease. A systematic review

Cocorullo¹

2017

GHIR

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IntroductionRationale. The non-surgical treatments for hemorrhoids include rubber band ligation (RBL), injection sclerotherapy (IS), infrared coagulation (IRC), anal stretch, cryosurgery, laser hemorroidectomy. These treatments are usually performed in outpatient clinics without anesthesia, so reducing the costs related to hospital stay, operation-theatre and anesthesia; moreover, these techniques are time-saving and allow preserving patients' working days. These procedures have found a large use in patients suffering bleeding and prolapse caused by early hemorrhoidal stages that did not found an improvement with conservative therapy.Objectives. The aim of this review is to provide a framework to select the best procedure for different patients in order to minimize complications and to obtain the cure for this widespread social problem. Among the treatments RBL, IS and IRC are the most utilized and were analyzed. It was analyzed: 1) Does these procedures help? 2) What are the common harms? 3) What are the rare harms? 4) How many are the recurrences? MethodsThis systematic review was undertaken in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines (2).Eligibility criteria. Studies on patient complaining of bleeding or prolapse due to hemorroidal disease managed with RBL, IS and IRC were collected. The hemorroidal degrees and the presence of bleeding or prolapses were analyzed. The well-defined treatment modality and the symptoms resolution as outcome measures were The non-surgical treatments for hemorrhoids are cost and time-saving techniques usually performed in patients suffering early hemorrhoidal disease. The most used are rubber band ligation (RBL), injection sclerotherapy (IS), and infrared coagulation (IRC

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“…21 It has been used in combination with rubber band ligation with increased success rates. 22 Infrared coagulation involves direct application of infrared waves resulting in protein necrosis. It is most applicable to Grades I and II hemorrhoids but is associated with high rates of recurrence when substantial prolapse is present.…”

Section: Medical Treatment For Hemorrhoidsmentioning

confidence: 99%

Practice Parameters for the Management of Hemorrhoids (Revised)

Cataldo

Ellis

Gregorcyk

et al. 2005

Diseases of the Colon &Amp; Rectum

164

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Surgeons is dedicated to assuring high-quality patient care by advancing the science, prevention, and management of disorders and diseases of the colon, rectum, and anus. The Standards Committee is composed of Society members who are chosen because they have demonstrated expertise in the specialty of colon and rectal surgery. This Committee was created to lead international efforts in defining quality care for conditions related to the colon, rectum, and anus. This is accompanied by developing Clinical Practice Guidelines based on the best available evidence. These guidelines are inclusive, and not prescriptive. Their purpose is to provide information on which decisions can be made, rather than dictate a specific form of treatment. These guidelines are intended for the use of all practitioners, health care workers, and patients who desire information about the management of the conditions addressed by the topics covered in these guidelines. It should be recognized that these guidelines should not be deemed inclusive of all proper methods of care or exclusive of methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all of the circumstances presented by the individual patient.

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A comparison of the simultaneous application of sclerotherapy and rubber band ligation, with sclerotherapy and rubber band ligation applied separately, for the treatment of haemorrhoids: a prospective randomized trial

Abstract: The combination of sclerotherapy and rubber band ligation for treatment of 2nd degree haemorrhoids is significantly more efficient than sclerotherapy on its own.

Cited by 56 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

The non-surgical management for hemorrhoidal disease. A systematic review

Practice Parameters for the Management of Hemorrhoids (Revised)

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