1- Objectives: comparison of Sodium tetradecyl sulfate1% and Ceftazidime and Metronidazole in management of perianal fistula. 2- Design: randomized clinical trial, not blinded. 3- Setting and conduct: 22 patients with perianal fistula divided into 3 groups randomly. In first group: Sodium tetradecyl sulfate1% and Ceftazidime, in second group: Sodium tetradecyl sulfate1% and Metronidazole and in third group: Ceftazidime and Metronidazole injected in fistula tract. Then compared closing of fistula tract, relief of pain and secretion in 3 groups. 4- Participants: inclusion criteria: perianal fistula in any age and sex. Exclusion criteria: severe systemic disease, pregnancy, breast-fed mothers. 5- Intervention: In first group: Sodium tetradecyl sulfate1% at first day and Ceftazidime at next day injected to fistula tract every other day for 1 week and then 3 times in week until external orifice of fistula closed. In second group: Sodium tetradecyl sulfate1% and Metronidazole and in third group: Ceftazidime and Metronidazole injected in similar style with first group. 6- Main outcome measures variables: recovery of perianal fistula.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013051913385N1
Registration date:2013-08-07, 1392/05/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-07, 1392/05/16
Registrant information
Name
Mahtab Farhadi
Name of organization / entity
Ahvaz Jondishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1445 8857
Email address
farhadi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapur University of Medical Sciences, Vice Chancellor for Research and Technology
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Sodium tetradecyl sulfat 1% and Ceftazidime and Metronidazole in treatment of patients with perianal fistula
Public title
The efficacy of Sodium tetradecyl sulfate 1% and Ceftazidime and Metronidazole in perianal fistula
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with perianal fistula.
Exclusion criteria: Pregnant or nursing women and patients with severe systemic disease.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
22
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
Ahvaz Ethics Committee of Jondishapur University of Medical Sciences
Street address
Ahvaz Jondishapur University of Medical Sciences, Golestan avenue
City
Ahvaz
Postal code
1579461257
Approval date
2011-10-15, 1390/07/23
Ethics committee reference number
ETH-259
Health conditions studied
1
Description of health condition studied
Anal fistula
ICD-10 code
K60.3
ICD-10 code description
Anal fistula
Primary outcomes
1
Description
Disappear of fistula tract
Timepoint
Six months after beginning of intervention
Method of measurement
Physical exam with prob
Secondary outcomes
1
Description
Disappear of pain
Timepoint
Six months after beginning of intervention
Method of measurement
History
2
Description
Disappear of discharge
Timepoint
Six months after beginning of intervention
Method of measurement
History and Physical exam
Intervention groups
1
Description
Group 1: one day Sodium tetradecyl sulfate1% (1cc) diluted with 3cc water for injection and next day Ceftazidime (4cc) injected in fistula tract for 1 week, then 3 times in week until recovery occurred. (Sodium tetradecyl sulfate is an Sclerosing agent which is produced in 1 cc vials in saturations %1 and %3. Ceftazidime is a antibiotic with 1g /vial that diluted with water for injection) .
Category
Treatment - Drugs
2
Description
Group 2: one day Sodium tetradecyl sulfate1% (1cc) diluted with 3cc water for injection and next day Metronidazole (4cc) injected in fistula tract for 1 week and then 3 times in week until recovery occurred. (Metronidazole is an antibiotic vial 500 mg / 100 ml) .
Category
Treatment - Drugs
3
Description
Group 3: one day Ceftazidime (4cc) and next day Metronidazole (4cc) injected in fistula tract for 1 week and then 3 times in week until recovery occurred.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Surgery ward of Imam Khomainy Hospital
Full name of responsible person
Mahtab Farhadi
Street address
Imam Khomainy Hospital, Azadegan avenue
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jondishapur University of Medical Sciences, Vice Chancellor for Research and Technology
Full name of responsible person
Mostafa Feghhi
Street address
Ahvaz Jondishapur University of Medical Sciences, Golestan avenue
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jondishapur University of Medical Sciences, Vice Chancellor for Research and Technology
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
Ahvaz Jondishapur University of Medical Sciences Surgery ward
Full name of responsible person
Mahtab Farhadi
Position
Surgery Assistant
Other areas of specialty/work
Street address
Imam Khomainy Hospital
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1222 7410
Fax
Email
bmohammadi13@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jondishapur University of Medical Sciences
Full name of responsible person
Mansour Alamshah
Position
General Surgeon. Fellowship of Vascular Surgery
Other areas of specialty/work
Street address
Golestan Hospital, Golestan avenue
City
Ahvaz
Postal code
Phone
+98 61 1374 3011
Fax
+98 61 1674 3076
Email
alamsha.m@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jondishapur University of Medical Sciences
Full name of responsible person
Mahtab Farhadi
Position
Surgery Assistant
Other areas of specialty/work
Street address
Imam Khomainy Hospital Surgery ward
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1222 7410
Fax
Email
bMohammadi 13@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)