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Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial

Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial
Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial

BACKGROUND: Optimum surgical intervention for low-grade haemorrhoids is unknown. Haemorrhoidal artery ligation (HAL) has been proposed as an efficacious, safe therapy while rubber band ligation (RBL) is a commonly used outpatient treatment. We compared recurrence after HAL versus RBL in patients with grade II-III haemorrhoids.

METHODS: This multicentre, open-label, parallel group, randomised controlled trial included patients from 17 acute UK NHS trusts. We screened patients aged 18 years or older presenting with grade II-III haemorrhoids. We excluded patients who had previously received any haemorrhoid surgery, more than one injection treatment for haemorrhoids, or more than one RBL procedure within 3 years before recruitment. Eligible patients were randomly assigned (in a 1:1 ratio) to either RBL or HAL with Doppler. Randomisation was computer-generated and stratified by centre with blocks of random sizes. Allocation concealment was achieved using a web-based system. The study was open-label with no masking of participants, clinicians, or research staff. The primary outcome was recurrence at 1 year, derived from the patient's self-reported assessment in combination with resource use from their general practitioner and hospital records. Recurrence was analysed in patients who had undergone one of the interventions and been followed up for at least 1 year. This study is registered with the ISRCTN registry, ISRCTN41394716.

FINDINGS: From Sept 9, 2012, to May 6, 2014, of 969 patients screened, 185 were randomly assigned to the HAL group and 187 to the RBL group. Of these participants, 337 had primary outcome data (176 in the RBL group and 161 in the HAL group). At 1 year post-procedure, 87 (49%) of 176 patients in the RBL group and 48 (30%) of 161 patients in the HAL group had haemorrhoid recurrence (adjusted odds ratio [aOR] 2·23, 95% CI 1·42-3·51; p=0·0005). The main reason for this difference was the number of extra procedures required to achieve improvement (57 [32%] participants in the RBL group and 23 [14%] participants in the HAL group had a subsequent procedure for haemorrhoids). The mean pain 1 day after procedure was 3·4 (SD 2·8) in the RBL group and 4·6 (2·8) in the HAL group (difference -1·2, 95% CI -1·8 to -0·5; p=0·0002); at day 7 the scores were 1·6 (2·3) in the RBL group and 3·1 (2·4) in the HAL group (difference -1·5, -2·0 to -1·0; p<0·0001). Pain scores did not differ between groups at 21 days and 6 weeks. 15 individuals reported serious adverse events requiring hospital admission. One patient in the RBL group had a pre-existing rectal tumour. Of the remaining 14 serious adverse events, 12 (7%) were among participants treated with HAL and two (1%) were in those treated with RBL. Six patients had pain (one treated with RBL, five treated with HAL), three had bleeding not requiring transfusion (one treated with RBL, two treated with HAL), two in the HAL group had urinary retention, two in the HAL group had vasovagal upset, and one in the HAL group had possible sepsis (treated with antibiotics).

INTERPRETATION: Although recurrence after HAL was lower than a single RBL, HAL was more painful than RBL. The difference in recurrence was due to the need for repeat bandings in the RBL group. Patients (and health commissioners) might prefer such a course of RBL to the more invasive HAL.

FUNDING: NIHR Health Technology Assessment programme.

Adult, Aged, Ambulatory Surgical Procedures/adverse effects, Female, Follow-Up Studies, Health Care Costs/statistics & numerical data, Hemorrhoids/economics, Humans, Ligation/adverse effects, Male, Middle Aged, Quality-Adjusted Life Years, Recurrence, Reoperation/methods, Rubber, Severity of Illness Index, Treatment Outcome, Young Adult
0140-6736
356-364
Brown, Steven R.
18421146-71a1-452a-b7cd-b872aa34aed0
Tiernan, James P.
ac9f5a0f-b253-4866-978f-14c7f9b99f8e
Watson, Angus J.M.
42360218-4655-4701-a34a-5dc4d0007542
Biggs, Katie
76c8d47d-9971-4119-97ba-83a72f6517d3
Shephard, Neil
43920f6b-69e3-4116-9502-26dd55486ec4
Wailoo, Allan J.
20cbc275-d93f-4d75-9d55-86b94d3c7f02
Bradburn, Mike
c845a405-6815-49e3-a94d-b7489263d0f0
Alshreef, Abualbishr
5c8c2ac4-feb0-4940-9623-05ed2995853d
Hind, Daniel
d0246cbf-e8b6-45c2-9412-76e0988852f3
Nugent, Karen
79fcb89d-6ff2-47b8-ac2c-2afb24954456
HubBLe Study team
Brown, Steven R.
18421146-71a1-452a-b7cd-b872aa34aed0
Tiernan, James P.
ac9f5a0f-b253-4866-978f-14c7f9b99f8e
Watson, Angus J.M.
42360218-4655-4701-a34a-5dc4d0007542
Biggs, Katie
76c8d47d-9971-4119-97ba-83a72f6517d3
Shephard, Neil
43920f6b-69e3-4116-9502-26dd55486ec4
Wailoo, Allan J.
20cbc275-d93f-4d75-9d55-86b94d3c7f02
Bradburn, Mike
c845a405-6815-49e3-a94d-b7489263d0f0
Alshreef, Abualbishr
5c8c2ac4-feb0-4940-9623-05ed2995853d
Hind, Daniel
d0246cbf-e8b6-45c2-9412-76e0988852f3
Nugent, Karen
79fcb89d-6ff2-47b8-ac2c-2afb24954456

Brown, Steven R., Tiernan, James P., Watson, Angus J.M., Biggs, Katie, Shephard, Neil, Wailoo, Allan J., Bradburn, Mike, Alshreef, Abualbishr and Hind, Daniel , HubBLe Study team (2016) Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. The Lancet, 388 (10042), 356-364. (doi:10.1016/S0140-6736(16)30584-0).

Record type: Article

Abstract

BACKGROUND: Optimum surgical intervention for low-grade haemorrhoids is unknown. Haemorrhoidal artery ligation (HAL) has been proposed as an efficacious, safe therapy while rubber band ligation (RBL) is a commonly used outpatient treatment. We compared recurrence after HAL versus RBL in patients with grade II-III haemorrhoids.

METHODS: This multicentre, open-label, parallel group, randomised controlled trial included patients from 17 acute UK NHS trusts. We screened patients aged 18 years or older presenting with grade II-III haemorrhoids. We excluded patients who had previously received any haemorrhoid surgery, more than one injection treatment for haemorrhoids, or more than one RBL procedure within 3 years before recruitment. Eligible patients were randomly assigned (in a 1:1 ratio) to either RBL or HAL with Doppler. Randomisation was computer-generated and stratified by centre with blocks of random sizes. Allocation concealment was achieved using a web-based system. The study was open-label with no masking of participants, clinicians, or research staff. The primary outcome was recurrence at 1 year, derived from the patient's self-reported assessment in combination with resource use from their general practitioner and hospital records. Recurrence was analysed in patients who had undergone one of the interventions and been followed up for at least 1 year. This study is registered with the ISRCTN registry, ISRCTN41394716.

FINDINGS: From Sept 9, 2012, to May 6, 2014, of 969 patients screened, 185 were randomly assigned to the HAL group and 187 to the RBL group. Of these participants, 337 had primary outcome data (176 in the RBL group and 161 in the HAL group). At 1 year post-procedure, 87 (49%) of 176 patients in the RBL group and 48 (30%) of 161 patients in the HAL group had haemorrhoid recurrence (adjusted odds ratio [aOR] 2·23, 95% CI 1·42-3·51; p=0·0005). The main reason for this difference was the number of extra procedures required to achieve improvement (57 [32%] participants in the RBL group and 23 [14%] participants in the HAL group had a subsequent procedure for haemorrhoids). The mean pain 1 day after procedure was 3·4 (SD 2·8) in the RBL group and 4·6 (2·8) in the HAL group (difference -1·2, 95% CI -1·8 to -0·5; p=0·0002); at day 7 the scores were 1·6 (2·3) in the RBL group and 3·1 (2·4) in the HAL group (difference -1·5, -2·0 to -1·0; p<0·0001). Pain scores did not differ between groups at 21 days and 6 weeks. 15 individuals reported serious adverse events requiring hospital admission. One patient in the RBL group had a pre-existing rectal tumour. Of the remaining 14 serious adverse events, 12 (7%) were among participants treated with HAL and two (1%) were in those treated with RBL. Six patients had pain (one treated with RBL, five treated with HAL), three had bleeding not requiring transfusion (one treated with RBL, two treated with HAL), two in the HAL group had urinary retention, two in the HAL group had vasovagal upset, and one in the HAL group had possible sepsis (treated with antibiotics).

INTERPRETATION: Although recurrence after HAL was lower than a single RBL, HAL was more painful than RBL. The difference in recurrence was due to the need for repeat bandings in the RBL group. Patients (and health commissioners) might prefer such a course of RBL to the more invasive HAL.

FUNDING: NIHR Health Technology Assessment programme.

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e-pub ahead of print date: 25 May 2016
Published date: 23 July 2016
Keywords: Adult, Aged, Ambulatory Surgical Procedures/adverse effects, Female, Follow-Up Studies, Health Care Costs/statistics & numerical data, Hemorrhoids/economics, Humans, Ligation/adverse effects, Male, Middle Aged, Quality-Adjusted Life Years, Recurrence, Reoperation/methods, Rubber, Severity of Illness Index, Treatment Outcome, Young Adult

Identifiers

Local EPrints ID: 443278
URI: http://eprints.soton.ac.uk/id/eprint/443278
ISSN: 0140-6736
PURE UUID: 7dfe738b-713c-4750-8490-00867ae89e12

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Date deposited: 19 Aug 2020 16:33
Last modified: 16 Mar 2024 09:00

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Contributors

Author: Steven R. Brown
Author: James P. Tiernan
Author: Angus J.M. Watson
Author: Katie Biggs
Author: Neil Shephard
Author: Allan J. Wailoo
Author: Mike Bradburn
Author: Abualbishr Alshreef
Author: Daniel Hind
Author: Karen Nugent
Corporate Author: HubBLe Study team

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