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.
Lateral internal sphincterotomy, the most common treatment for chronic anal fissure, may cause permanent injury to the anal sphincter, which can lead to fecal incontinence. We compared two nonsurgical treatments that avert the risk of fecal incontinence.treatment with either topical nitroglycerin or botulinum toxin is effective as an alternative to surgery
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Botox injection to be injected in internal anal sphincter to see the curative response in comparison to gtn cream application
0.2%GTN applied on anal canal.
Pak-Emirates Military Hospital
Rawalpindi, Punjab Province, Pakistan
RECRUITINGHealing of fissure
All the patients will undergo a pretreatment evaluation that will include clinical inspection of the fissure based on 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 and symptoms including post-defecatory or nocturnal pain, bleeding, or both. Then they will be randomized to receive treatment with either botulinum toxin or 0.2 percent nitroglycerin ointment applied twice daily for six weeks. The outcome in each group will be evaluated clinically.The end point of the study would be complete healing after treatment. The treatment will be considered successful if the fissure healed. Persistence of the fissure in the absence of symptoms will be considered as symptomatic improvement.The Secondary endpoints will measurement of post defecatory pain on Visual analogue scale (VAS) at each visit.
Time frame: Within 6 weeks
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