The aim of this study is comparison of the effect of botulinum toxin and Sphincterotomy in treatment of chronic anal fissure. This is nonblind clinical trial study. Patients with history of chronic anal fissure; skin tag or visible fibers of internal muscles of anal on bottom of ulcer will be included and acute anal fissure; fistula; inflammatory bowel disease; history of anal surgery; pregnancy will be excluded. After explaining the objectives of the study and obtaining the informed consent, patients randomized to random block 4-way A and B are divided two treatment group. one group with botulinum toxin and the second group with Sphincterotomy will be treated. Wound healing no pain during defecation are study out comes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081429352N1
Registration date:2016-09-10, 1395/06/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-10, 1395/06/20
Registrant information
Name
Ehsan Gharib
Name of organization / entity
Islamic Azad University Shahrood Branch
Country
Iran (Islamic Republic of)
Phone
+98 23 3223 7331
Email address
ehsan-gharib@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrood Islamic Azad University
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative outcomes of botulinum toxin and Sphincterotomy in treatment of chronic anal fissure
Public title
Effect of botulinum toxin and Sphincterotomy in treatment of anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of chronic anal fissure; skin tag or visible fibers of internal muscles of anal on bottom of ulcer
exclusion criteria: acute anal fissure; fistula; inflammatory bowel disease; history of anal surgery; pregnancy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud
City
Shahroud
Postal code
3614773955
Approval date
2015-04-08, 1394/01/19
Ethics committee reference number
930/33
Health conditions studied
1
Description of health condition studied
Chronic anal fissure
ICD-10 code
k60.1
ICD-10 code description
Chronic anal fissure
Primary outcomes
1
Description
wound healing
Timepoint
1,2,4,8 and then monthly for 6 month after treatment
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Pain During Defecation
Timepoint
1,2,4,8 and then monthly for 6 month after treatment