Anal fistula is a linkage between skin and anal canal.the most common cause of fistula is abscess formation in the anal crypts .surgery is the best treatmen for symptomatic anal fistula. if anal fistula left untreated can cause recurrent abscess formation. Surgical wound complications include pain, itching, discharge and infections. So employing methods that can accelerate wound healing has a significant impact on patient quality of life. Amniotic membrane transplantation is an idea for this purpose . Amniotic membrane transplantation have been used in various treatment such as adhesions resulting from surgery, corneal surface reconstruction, repair of injured tendons ,…
In recent years several studies regarding the use of amniotic membrane as a biological dressing especially in the treatment of burns is published .Amniotic membrane has several advantages such as availability, low immunogenecity, high potency of differentiation . therefore, further research to evaluate the effect of biological dressings especially amniotic membrane for treatment of anal fistula is reasonable.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310219936N6
Registration date:2013-11-15, 1392/08/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-15, 1392/08/24
Registrant information
Name
Leila Ghahramani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1623 5586
Email address
lghahraman@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences
Expected recruitment start date
2012-07-10, 1391/04/20
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of amniotic membrane graft on wound healing process and decrease complications in patient who undergone anal fistulatomy
Public title
Evaluation the effect of amniotic membrane graft on wound healing process and decrease complications in patient who undergone anal fistulatomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-65 years old; low type fistula; first time to be operated.
Exclusion: history of TB and ; history of previous fistula operation; high type fistula; immunosuppression; procitis; radiotherapy; complex fistula; stool or gas incontinency and egg allergy.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
85
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Siences
Street address
Shiraz
City
Shiraz
Postal code
Approval date
2012-05-17, 1391/02/28
Ethics committee reference number
91-01-01-5270
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
Post operation complication
Timepoint
1, 3, 7, 21, 28th days of post operation
Method of measurement
Evaluation of score of pain after surgery in both groups with visual analog scale (VAS)
Secondary outcomes
1
Description
Discharge
Timepoint
1, 3, 7, 21 and 28th days of post operation
Method of measurement
Subjectively
2
Description
Itching
Timepoint
1, 3, 7, 21 and 28th days of post operation
Method of measurement
Subjectively no variable
Intervention groups
1
Description
In group B:
Amniotic membrane is not the only place marsupialization thread Monocryl (0-4).
Category
Treatment - Surgery
2
Description
In group A :
Amniotic membrane graft group patients using 0-4 suture is Monocryl (amniotic membrane on the bottom layer to the edges of the fistula tract located Monocryl thread is fixed)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgical Clinic of Shiraz University of Medical Sciences
Full name of responsible person
Dr Leila Ghahramani- Assistant professor of General Surgery
Street address
Colorectal Research Center, Faghihi hospital, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Hatam
Street address
Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Colorectal Research Center, Shiraz university of medical sciences
Full name of responsible person
Dr Alireza Safarpour
Position
MD, MPH
Other areas of specialty/work
Street address
Colorectal Research Center, Shiraz university of Medical Siences, Shiraz
City
Shiraz
Postal code
Iran
Phone
+98 71 1230 6972
Fax
Email
fsafarpour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Colorectal Research Center, Shiraz university of medical sciences
Full name of responsible person
Dr Leila Ghahramani
Position
Colorectal flowship-assistant professor
Other areas of specialty/work
Street address
Colorectal Research Center Shiraz university of medical sciences
City
Shiraz
Postal code
Phone
+98 71 1230 6972
Fax
Email
colorectal2@sums.acir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Colorectal Research Cente
Full name of responsible person
Zahra Zabangirfard
Position
Colorectal Research Center, Shiraz university of medical sciences
Other areas of specialty/work
Street address
Colorectal Research Center, Shiraz university of Medical Siences, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1230 6972
Fax
Email
colorectal2@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)