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IRCT201011285263N1 IRCT 2011-02-03 Vice- chancellor for Reasearch of Hamedan University of Medical Sciences Comparison of lateral internal sphincterotomy and botulinum toxin injection in treatment of chronic anal fissure Comparison of lateral internal sphincterotomy and botulinum toxin injection in treatment of chronic anal fissure 2010-08-23 anticipated 86 Complete https://irct.ir/trial/5612 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. N/A chronic anal fissure. Intervention 1: Intervention group: the patients set in knee chest position and single dose of botax, under local anesthesia is injected (25units) in internal sphincter in sitution of 3 and 9 o'clock. Intervention 2: Control group: the patients set in trendelenberg position and under general anesthesia about 30 percent of internal muscle sphincter (in 3 oclock sitution) was ligated with knife (number 15).
public Dr Hamid Reza Fereidoonin
Besat blvd., Besat Hospital
Hamedan Iran (Islamic Republic of) +98 81 1264 0049 h.fereidoonian@umsha.ac.ir Hamedan University of Medical Sciences scientific Dr Hamid Reza Fereidoonian
Besat Hospital
Hamedan Iran (Islamic Republic of) +98 81 1264 0049 h.fereidoonian@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: diagnosis of chronic anal fissure (presented greater than 6 weeks), presence of triad of (sentinel pile, hypertrophy of papi and fibrosis of bed wound), age between18 and 100 years old Exclusion criteria: combination with other anal diseases such as: hemorrhoid, anal fistula, rectal prolapse and positive history of anorectal surgery, positive history of neuromuscular diseases (myesthenia gravis, multiple sclerosis, amiotrophic lateral sclerosis), breast feeding, pregnancy, positive history of drug consumption consist of aspirin, warfarin, aminoglycosides, chloroquine, aminoglycosides, chloroquine 18 years 100 years Both K60.1 chronic anal fissure Treatment - Drugs Treatment - Surgery Intervention group: the patients set in knee chest position and single dose of botax, under local anesthesia is injected (25units) in internal sphincter in sitution of 3 and 9 o'clock. Control group: the patients set in trendelenberg position and under general anesthesia about 30 percent of internal muscle sphincter (in 3 oclock sitution) was ligated with knife (number 15) Wound healing. Timepoint: one week and two months after discharge. Method of measurement: Complete Wound Healing. Complications. Timepoint: One week and two month after discharge. Method of measurement: Standard form. Vice- chancellor for Reasearch of Hamedan University of Medical Sciences Approved 2010-08-14 Ethics Committee of Medical Science Shahid Fahmideh street Hamedan Iran (Islamic Republic of)