Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment … (NCT05590520) | Clinical Trial Compass
UnknownNot Applicable
Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure
Pakistan90 participantsStarted 2022-11-01
Plain-language summary
Patients will be randomized to receive treatment with either a total of 20 U of botulinum toxin(diluted in saline to a concentration of 50 U per milliliter.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis: evidence of posterior circumscribed ulcer, with a large sentinel tag of skin, induration at the edges, and exposure of the horizontal fibers of the internal anal sphincter
* symptoms (post-defecatory or nocturnal pain, bleeding, or both) lasting for more than two months.
Exclusion Criteria:
* Patients with acute fissure
* fissure associated with other conditions (i.e., inflammatory bowel diseases, HIV infection, hemorrhoids, fistula in ano, anal abscesses, or anal or perianal cancer)
* those who had undergone previous surgical procedures in the anal canal.
* known hypersensitivity to component of the formulations of type A BTX
* pregnant or breast-feeding women 6-refusal of consent