None listed
Conditions
Brief summary
Chronic anal fissure is a common condition. An acute tear at the anal verge, if fails to heal within six weeks, leads to chronicity; characterized by increased anal tone, epithelial breach and fibrosis at the base of the fissure. The aim of the treatment, therefore, is to reduce the anal tone and increase the blood supply for healing. Traditionally the treatment has been surgical i.e. lateral internal sphincterotomy under anaesthesia. Apart from surgery, several pharmacological options, aimed at reducing anal tone, have also been used with variable success rates. Out of those Glyceryl Trinitrate (GTN), Diltiazem and Botulinum toxin (Botox) have been studied with successful outcomes. The current research regarding comparison of GTN and Botox is limited, and the RCTs conducted so far have either short follow up duration or small sample sizes. Moreover no study has been conducted locally to compare the efficacy of the two drugs. The hypothesis of the study is that Botox injection leads to healing of the fissure more effectively than GTN.
Interventions
Botox (Botolinum Toxin Type A)
A solution of Botulinum Toxin in 0.9% saline will be made in 50 Units/ml concentration. 0.4 ml of the prepared solution will be injected in the intersphincteric groove on either side of the midline anteriorly (total amount of Botulinum Toxin used per patient will be 40 Units). The injection would be performed with the patient either in left lateral position or knee-elbow position.
The treatment will be administered in single session by the principal investigators i
Botox (Botolinum Toxin Type A) A solution of Botulinum Toxin in 0.9% saline will be made in 50 Units/ml concentration. 0.4 ml of the prepared solution will be injected in the intersphincteric groove on either side of the midline anteriorly (total amount of Botulinum Toxin used per patient will be 40 Units). The injection would be performed with the patient either in left lateral position or knee-elbow position. The treatment will be administered in single session by the principal investigators in operating room where patient monitoring is available.
Sponsors
Khyber Medical College
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All adult patients (Age greater than or equal to 18 years) with chronic anal fissure
Exclusion criteria
Known allergy to Botox Coexistent other anal conditions like hemorrhoids, fistula in ano etc Fissures not located posteriorly or anteriorly Coexistent inflammatory bowel disease like ulcerative colitis, crohn's disease History of cluster headaches or migraine
Outcome results
None listed