A comparison between the effects of Topical ointment Sucralfate10% and topical placebo on Wound Healing & Postoperative pain in patients with prianal Fistula after surgery
This double blind clinical trial study is based on the patients suffering from perianal fistula whose fistules will be operated in sari Imam khomeini hospital during 1393.We will investigate the effect of sucralfate ointment 10% on post operation pain release and it's role in wound healing compare with the placebo .All the patients will be cured through fistoiotomy by probing the fistula tract under spinal anesthesia in lithotomy position.The pateints will be hospitalized for one day.During the post op period, they will be divided into two groups; the first one will be treated group using placebo and the second one will be the intervening group taking sucralfate10% twice a day.The patients will be visited in 2,4&6 weeks later, and the pain intensity will be recorded based on VAS ,while the amount of the wound healing will also be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041414483N5
Registration date:2015-05-08, 1394/02/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-08, 1394/02/18
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
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the effects of Topical ointment Sucralfate10% and topical placebo on Wound Healing & Postoperative pain in patients with prianal Fistula after surgery
Public title
Effect of sucralfate in treatment of post operation anal fistula wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:all the patients whose perianal fistula was operated(fistulotomy)
Exclusion criteria:long term consumption of corticosteroid;poorly controlled diabetic patients ;the patient who suffering TB; crohn disease ;malignancy ;radiation therapy ;the patients whose are on chemotherapy and pased less than two weeks after chemotherapy.
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
Moalem Sq, Sari
City
Sari
Postal code
Approval date
2015-03-04, 1393/12/13
Ethics committee reference number
13/12/1393
Health conditions studied
1
Description of health condition studied
Perianal fistula
ICD-10 code
k60.3
ICD-10 code description
Anal fistula
Primary outcomes
1
Description
Post op pain
Timepoint
2,4,6weeks after intervention
Method of measurement
VAS
2
Description
Wound healing
Timepoint
2,4,6weeks after intervention
Method of measurement
Mucosal coverage of wound
Secondary outcomes
1
Description
Painful deffication
Timepoint
2,4,6weeks after intervention
Method of measurement
VAS
2
Description
Discharge
Timepoint
2,4,6 weeks after intervention
Method of measurement
Visual observation
3
Description
Itching
Timepoint
2,4,6 weeks after intervention
Method of measurement
5-D pruritis scale
4
Description
Post op coplication
Timepoint
2,4,6 weeks after intervention
Method of measurement
Physical examination
5
Description
Side effect of medication
Timepoint
2,4,6 weeks after intervention
Method of measurement
History
6
Description
Post op bleeding
Timepoint
2,4,6weeks after intervention
Method of measurement
Physical examination
7
Description
Fecal incontinency
Timepoint
2,4,6weeks after itervention
Method of measurement
History
8
Description
Gas incontinency
Timepoint
2,4,6 weeks after intervention
Method of measurement
History
9
Description
Couret count
Timepoint
2,4,6 weeks after intervention
Method of measurement
Count number
Intervention groups
1
Description
The control group:taking pelacebo topical ointment vaselin twice daily for 6weeks
Category
Treatment - Drugs
2
Description
The intervention group:taking Topical ointment sucralfat 10% twice daily for 6weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Mina Alvandipour
Street address
Amirmazandarani St, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Ahmadali Enayati
Street address
Moallem Sq, Sari
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mina Alvandipour
Position
Staff colorectal
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Amirmazandarani St, Sari
City
Sari
Postal code
Phone
+98 11 3225 6329
Fax
Email
Malvandipour@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Hasan Tavakoli
Position
Resident of surgery/Student
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Amirmazandarani St, Sari
City
Sari
Postal code
Phone
+98 11 3325 8082
Fax
Email
Dr.tavakoli1386@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)