The aim of this study is to compare the complications and outcomes of botulinum toxin injection with partial lateral internal sphincterotomy in the treatment of chronic anal fissure. This study is a randomized controlled clinical trial, done in surgical department of Hamedan Besat hospital. All of the patients with diagnosis of chronic anal fissure and triad of sentinel pile, hypertrophy of papi, and fibrosis of bed wound consist of 86 patients are assigned to undergo partial lateral internal sphincterotomy under general anesthesia or receive an injection of 12.5 unit of toxin on both sides of anus (totally, 25 units) under local anesthesia using lidocaine gel. Improvement rate and complications including pain and bleeding will be compared in the two follow-up periods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011285263N1
Registration date:2011-02-03, 1389/11/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-02-03, 1389/11/14
Registrant information
Name
Hamid Reza Fereidoonian
Name of organization / entity
Hamedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0049
Email address
h.fereidoonian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research of Hamedan University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-02-21, 1389/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of lateral internal sphincterotomy and botulinum toxin injection in treatment of chronic anal fissure
Public title
Comparison of lateral internal sphincterotomy and botulinum toxin injection in treatment of chronic anal fissure
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Medical Science
Street address
Shahid Fahmideh street
City
Hamedan
Postal code
Approval date
2010-08-14, 1389/05/23
Ethics committee reference number
57236/9/35/16پ
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
one week and two months after discharge
Method of measurement
Complete Wound Healing
Secondary outcomes
1
Description
complications
Timepoint
One week and two month after discharge
Method of measurement
Standard form
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Depatment of Surgery-Besat Hospital
Full name of responsible person
Dr Hamid Reza Fereidoonian
Street address
Besat bolvar
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- chancellor for Reasearch of Hamedan University of Medical Sciences
Full name of responsible person
Dr Hamid Reza Fereidoonian
Street address
shahid fahmideh street
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice- chancellor for Reasearch of Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Hamid Reza Fereidoonin
Position
Resident of surgery
Other areas of specialty/work
Street address
Besat blvd., Besat Hospital
City
Hamedan
Postal code
Phone
+98 81 1264 0049
Fax
Email
h.fereidoonian@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Hamid Reza Fereidoonian
Position
Resident of general surgery
Other areas of specialty/work
Street address
Besat Hospital
City
Hamedan
Postal code
Phone
+98 81 1264 0049
Fax
Email
h.fereidoonian@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Hamid Reza Fereidoonian
Position
Resident of surgery
Other areas of specialty/work
Street address
Besat Hospital
City
Hamedan
Postal code
Phone
Fax
Email
h.fereidoonian@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)