Chronic Anal Fissure Clinical Trial
Official title:
Treatment of Chronic Anal Fissure, Lateral Internal Sphincterotomy Versus Local Injection of High Dose Botulinum Toxin: A Randomized Clinical Trial
comparison between the effect of lateral sphincterotomy against high dose botox injection in chronic anal fissure the outcome was healing time, recurrence continence relapse pain pruritus
This randomized comparative clinical trial was carried out over 2 year in the period between
January 2018 and December 2019 on total number of 96 patients suffering chronic anal fissure
the participants were randomly allocated into two groups each 48 patients ; group (1) the
botulinum ( Botox) group, they were subjected to 80 IU Botox injection as an intervention for
treatment of chronic anal sphincter, and group 2 the sphincterotomy group, underwent internal
sphincterotomy as a surgical intervention for treatment of chronic anal fissure.
The study was approved by the institutional review board and the local ethical committee of
our university hospital The condition of the current study is chronic anal fissure defined as
the presence of anterior or posterior chronic anal wound with skin tag at its lower end and
hypertrophied anal papilla at its upper end with induration around its edges in patients
complaining of anal pain, constipation, and/or fresh anal bleeding for at least two months.
Randomization was achieved using computer generated cards. Inclusion criteria; patients
suffering chronic anal fissure aged above 16 years old Exclusion criteria; those with
previous anal surgery, complicated anal fissure, unfit for surgery, specific disease as
Crohn's disease and ulcerative colitis, malignancy, anal fistula or abscess those with
systemic disease requiring treatment with calcium channel blockers and /or nitrates Patients
of both groups were subjected to thorough history taking, clinical examination, digital
rectal examination and anorectal manometry for diagnosis of chronic anal fissure and
exclusion of any other anal condition and incontinence, patient signed an informed written
consent, routine preoperative investigations performed as usual.
Interventions;
1. Botulinum toxin (Botox) injection; was performed under general anesthesia in the
lithotomy position, where 80 IU of Botox was injected in four positions each 20 IU
namely in 5, 7, 11, and 1 O'clock positions in the intersphincteric space not deeper
than the midpoint of the anal canal.
2. Lateral internal sphincterotomy; was performed under general anesthesia where the lower
part of the internal sphincter was cut by electrocautery on the left lateral position to
an extent not beyond the proximal end of the fissure, the sentinel pile was also
removed.
After the procedure patients were advised for bulking agents, stool softener, and sitz baths
The follow up was carried out in the outpatient clinic by the attending surgeon (not a study
participant) after 1 week then 1, 2, 3, 6, 9 and 12 months post-procedure.
The primary outcome of the current study is complete healing of the chronic anal fissure,
recurrence in the follow up time, and development of incontinence, incontinence is described
as in (the Cleveland Clinic Florida-Fecal Incontinence (CCF-FI) scoring system), which
contains 5 questions on solid and liquid stool leakage, gas leakage, pad use, and lifestyle
restriction. the secondary outcome is postoperative or post-injection pain measured by visual
analogue scale (VAS) and the time taken for complete healing of fissure (defined as complete
epithelialization of the fissure).
Demographic data, presentation data, follow up data including primary and secondary outcome
all collected and analyzed properly using t test, chi square test, and Z test in SPSS program
22 version.
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