Comparison between topical phenytoin 1% and placebo locally to reduce postoperative pain and recovery time for patients with perianal fistula after fistulotomy
The study is a randomized, double-blind, placebo-controlled, single-center. The study population: Exclusion criteria included: Long-term use of corticosteroids ;diabetes POORLY CONTROL;TB patients; people with Coron disease; people with underlying malignancy;patients who have had radiation; patients with a history cemotherapy less than 2 weeks; allergy to phenytoin.
Inclusion criteria: all patients with anal fistula.
Inclusion criteria: all patients with anal fistula. the total sample size are 44 patients. intervention: application of topical cream phenytoin 1% on wound healing after anal fistulectomy. after surgery primary outcome: accelerate healing, reduce pain,the Recurrence,Anal itching, fecal and gas continency
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041314483N4
Registration date:2016-03-21, 1395/01/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-21, 1395/01/02
Registrant information
Name
Mina Alvandipour
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1225 6329
Email address
malvandipour@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences and Health Services
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2016-03-21, 1395/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between topical phenytoin 1% and placebo locally to reduce postoperative pain and recovery time for patients with perianal fistula after fistulotomy
Public title
Phenytoin ointment in healing anal fistula after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria included: Long-term use of corticosteroids ;diabetes POORLY CONTROL ;TB patients; people with Coron disease; people with underlying malignancy;patients who have had radiation; patients with a history cemotherapy less than 2 weeks; allergy to phenytoin.
Inclusion criteria: all patients with anal fistula.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
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
Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, beginning Valiasr Highway, Jouybar three way,Imam Khomeini square,Sari,Iran
City
Sari
Postal code
4817844718
Approval date
2016-02-21, 1394/12/02
Ethics committee reference number
IR.MAZUMS.REC.94-1598
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
wound healing
Timepoint
2,4,6 weeks after surgery
Method of measurement
physical exam
2
Description
fecal and gas incontinency
Timepoint
2,4,6 weeks after surgery
Method of measurement
wexner questioner
3
Description
post operative pain
Timepoint
2,4,6 weeks after surgery
Method of measurement
SELFE RELATED ON A VISUAL ANALOG SCALE
Secondary outcomes
1
Description
anal pruritus
Timepoint
2,4,6 weeks after surgery
Method of measurement
5-D Pruritus Scale
2
Description
wound secretion
Timepoint
2,4,6 weeks after surgery
Method of measurement
physical exam
3
Description
Pain during defecation
Timepoint
2,4,6 weeks after surgery
Method of measurement
SELFE RELATED ON A VISUAL ANALOG SCALE
4
Description
post operative complications
Timepoint
2,4,6 weeks after surgery
Method of measurement
physical exam
Intervention groups
1
Description
All patients treated by probing fistula tract in lithotomy position under spinal anesthesia. Then direction is probe guided and fistulotomy done in its length and preserve sphincter muscles involved in CONTINENCY. then bed of wound currete to remove epithelial lining. Patients are hospitalized for a day. the Topical cream phenytoin 1% used to 2 times a day. for all patients prescribed an oral NSAIDS.
Category
Treatment - Drugs
2
Description
All patients treated by probing fistula tract in lithotomy position under spinal anesthesia. Then direction is probe guided and fistulotomy done in its length and preserve sphincter muscles involved in CONTINENCY. then bed of wound currete to remove epithelial lining. Patients are hospitalized for a day. the Topical placebo used to 2 times a day. for all patients prescribed an oral NSAIDS