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 band 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 o...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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NIHR Journals Library
2016-11-01
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| Series: | Health Technology Assessment |
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| Online Access: | https://doi.org/10.3310/hta20880 |
| _version_ | 1828472616495611904 |
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| author | Steven Brown Jim Tiernan Katie Biggs Daniel Hind Neil Shephard Mike Bradburn Allan Wailoo Abualbishr Alshreef Lizzie Swaby Angus Watson Simon Radley Oliver Jones Paul Skaife Anil Agarwal Pasquale Giordano Marc Lamah Mark Cartmell Justin Davies Omar Faiz Karen Nugent Andrew Clarke Angus MacDonald Phillip Conaghan Paul Ziprin Rohit Makhija |
| author_facet | Steven Brown Jim Tiernan Katie Biggs Daniel Hind Neil Shephard Mike Bradburn Allan Wailoo Abualbishr Alshreef Lizzie Swaby Angus Watson Simon Radley Oliver Jones Paul Skaife Anil Agarwal Pasquale Giordano Marc Lamah Mark Cartmell Justin Davies Omar Faiz Karen Nugent Andrew Clarke Angus MacDonald Phillip Conaghan Paul Ziprin Rohit Makhija |
| author_sort | Steven Brown |
| collection | DOAJ |
| description | Background: Optimal 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. Objective: The comparison of HAL with RBL for the treatment of grade II/III haemorrhoids. Design: A multicentre, parallel-group randomised 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) resulting in an incremental cost-effectiveness ratio of £104,427 per additional QALY. Conclusions: At 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. 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 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. 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 ISRCTN41394716. 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. |
| first_indexed | 2024-12-11T05:32:30Z |
| format | Article |
| id | doaj.art-4f2d5fb2b4e649d38ad2b774ca4a2d74 |
| institution | Directory Open Access Journal |
| issn | 1366-5278 2046-4924 |
| language | English |
| last_indexed | 2024-12-11T05:32:30Z |
| publishDate | 2016-11-01 |
| publisher | NIHR Journals Library |
| record_format | Article |
| series | Health Technology Assessment |
| spelling | doaj.art-4f2d5fb2b4e649d38ad2b774ca4a2d742022-12-22T01:19:23ZengNIHR Journals LibraryHealth Technology Assessment1366-52782046-49242016-11-01208810.3310/hta2088010/57/46The 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 evaluationSteven Brown0Jim Tiernan1Katie Biggs2Daniel Hind3Neil Shephard4Mike Bradburn5Allan Wailoo6Abualbishr Alshreef7Lizzie Swaby8Angus Watson9Simon Radley10Oliver Jones11Paul Skaife12Anil Agarwal13Pasquale Giordano14Marc Lamah15Mark Cartmell16Justin Davies17Omar Faiz18Karen Nugent19Andrew Clarke20Angus MacDonald21Phillip Conaghan22Paul Ziprin23Rohit Makhija24Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UKLeeds Teaching Hospitals NHS Trust, Leeds, UKSchool of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UKSchool of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UKSchool of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UKSchool of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UKSchool of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UKSchool of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UKSchool of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UKNHS Highland, Inverness, UKUniversity Hospitals Birmingham NHS Foundation Trust, Birmingham, UKOxford University Hospitals NHS Trust, Oxford, UKAintree University Hospital NHS Foundation Trust, Liverpool, UKNorth Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees, UKBarts Health NHS Trust, London, UKBrighton and Sussex University Hospitals NHS Trust, Brighton, UKNorthern Devon Healthcare NHS Trust, Devon, UKCambridge University Hospitals NHS Foundation Trust, Cambridge, UKNorth West London Hospitals NHS Trust, London, UKUniversity Hospital Southampton NHS Foundation Trust, Southampton, UKPoole Hospital NHS Foundation Trust, Poole, UKNHS Lanarkshire, Airdrie, UKRoyal Berkshire NHS Foundation Trust, Reading, UKImperial College Healthcare NHS Trust, London, UKPeterborough and Stamford Hospitals NHS Foundation Trust, Peterborough, UKBackground: Optimal 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. Objective: The comparison of HAL with RBL for the treatment of grade II/III haemorrhoids. Design: A multicentre, parallel-group randomised 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) resulting in an incremental cost-effectiveness ratio of £104,427 per additional QALY. Conclusions: At 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. 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 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. 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 ISRCTN41394716. 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.https://doi.org/10.3310/hta20880haemorrhoidal artery ligationhalothdrubber band ligationhaemorrhoidsgrade ii pilesgrade iii pilesrecurrencehaemorrhoid symptom severity scoreeq-5dvaizey score |
| spellingShingle | Steven Brown Jim Tiernan Katie Biggs Daniel Hind Neil Shephard Mike Bradburn Allan Wailoo Abualbishr Alshreef Lizzie Swaby Angus Watson Simon Radley Oliver Jones Paul Skaife Anil Agarwal Pasquale Giordano Marc Lamah Mark Cartmell Justin Davies Omar Faiz Karen Nugent Andrew Clarke Angus MacDonald Phillip Conaghan Paul Ziprin Rohit Makhija 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 Health Technology Assessment haemorrhoidal artery ligation halo thd rubber band ligation haemorrhoids grade ii piles grade iii piles recurrence haemorrhoid symptom severity score eq-5d vaizey score |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | haemorrhoidal artery ligation halo thd rubber band ligation haemorrhoids grade ii piles grade iii piles recurrence haemorrhoid symptom severity score eq-5d vaizey score |
| url | https://doi.org/10.3310/hta20880 |
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