Bilateral versus unilateral botulinum toxin injections for chronic anal fissure: a randomised trial |
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Authors: | S. A. Pilkington,R. Bhome author-information" >,R. E. Welch,F. Ku,C. Warden,S. Harris,J. Hicks,C. Richardson,T. C. Dudding,J. S. Knight,A. T. King,A. H. Mirnezami,N. E. Beck,P. H. Nichols,K. P. Nugent |
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Affiliation: | 1.Department of Colorectal Surgery, Southampton General Hospital,University Hospitals Southampton NHS Trust,Southampton,UK;2.Academic Surgical Unit,University of Southampton,Southampton,UK;3.School of Medicine,University of Southampton,Southampton,UK;4.Department of Colorectal Surgery,University of Cape Town, Groote Schuur Hospital,Cape Town,South Africa;5.Primary Care and Population Studies Unit,University of Southampton, Southampton General Hospital,Southampton,UK |
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Abstract: | BackgroundBotulinum toxin injected into the internal anal sphincter is used in the treatment of chronic anal fissure but there is no standardised technique for its administration. This randomised single centre trial compares bilateral (either side of fissure) to unilateral injection.MethodsParticipants were randomised to receive bilateral (50?+?50 units) or unilateral (100 units) Dysport® injections into the internal anal sphincter in an outpatient setting. Injection-related pain assessed by visual analogue scale was the primary outcome measure. Secondary outcomes were healing rate, fissure pain, incontinence, and global health scores.ResultsBetween October 2008 and April 2012, 100 patients with chronic anal fissure were randomised to receive bilateral or unilateral injections. Injection-related pain was comparable in both groups. There was no difference in healing rate. Initially, there was greater improvement in fissure pain in the bilateral group but at 1 year the unilateral group showed greater improvement. Cleveland Clinic Incontinence score was lower in the unilateral group in the early post-treatment period and global health assessment (EuroQol EQ-VAS) was higher in the unilateral group at 1 year.ConclusionsInjection-related pain was similar in bilateral and unilateral injection groups. Unilateral injection was as effective as bilateral injections in healing and improving fissure pain without any deterioration in continence. |
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