Randomized Double-blind Placebo Controlled Trial of Topical Platelet Lysate hydrogel in patients with anal fissure referee to colorectal research center of shiraz medical university of medical sciences.
Anal fissure is a tear or crack in the distal anal canal that is associated with pain. It usually involves the epithelium, but it may involve the whole of anal mucosa in long term. The etiology of anal fissure is unknown, but the patients usually are accompanied by some risk factors such as constipation hypoxia increase sphincter pressure inflammatory bowel disease, malignancies, systemic disorders and sexual associated trauma. Platelet lysate hydrogel is hemoderivitive pharmaceutical formulation that contains plenty of growth factors. These growth factors can induce tissue regeneration and revascularization and fibroblast proliferation. These processes will conduce toward enhancing collagen synthesis especially in damaged tissues. This study is aimed to evaluating the probability of platelet lysate hydrogel effectiveness in treatment of disease or retardation the development of the disease in anal fissure patients. Patients with chronic and acute anal fissure will be randomized into A and B groups. Group A will receive platelet lysate hydrogel and Rectol® and group B will receive placebo and Rectol®. Both groups will be evaluated by one colorectal surgeon that will blind to this Study. All the patients will be followed and evaluated after two weeks. Statistical analysis will be conducted eventually.
General information
Acronym
Randomized Double-blind Controlled Trial of Topical Platelet Lysate hydrogel in patients wit
IRCT registration information
IRCT registration number:IRCT201304079936N4
Registration date:2013-07-02, 1392/04/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-02, 1392/04/11
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
Shiraz University of Medical Sciences
Expected recruitment start date
2013-02-03, 1391/11/15
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized Double-blind Placebo Controlled Trial of Topical Platelet Lysate hydrogel in patients with anal fissure referee to colorectal research center of shiraz medical university of medical sciences.
Public title
Randomized Double-blind Placebo Controlled Trial of Topical Platelet Lysate hydrogel in patients with anal fissure referee to colorectal research center of shiraz medical university of medical sciences.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1 )Patient with acute and chronic anal fissure. 2) Patient without previous history of peri-anal fistula. 3) Patient without previous history of peri-anal abscess. 4) Patient without previous history of IBD, radiation, STD, TB Chemotherapy. 5) Patient without previous history of hemorrhoidectomy or peri-anal procedure. 6) Patient without previous history of migraine. 7) Patient without previous history of no pregnant. 8) Patient without previous history of anterior or posterior midline fistula. 9) Patient without previous history of IHD.
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
There is significant differentiation between sphincter pressure in male and female therefore, management response in male and female will be are different as little then this study will be perform in female participantant .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2012-10-08, 1391/07/17
Ethics committee reference number
675
Health conditions studied
1
Description of health condition studied
Fissure
ICD-10 code
K60
ICD-10 code description
Fissure and fistula of anal and rectal regions
Primary outcomes
1
Description
Treatment of fissure
Timepoint
Two weeks after initial treatment
Method of measurement
Exam by colorectal surgeon and complete the form
Secondary outcomes
empty
Intervention groups
1
Description
The rectul drug will be used once daily in control group.
Category
Treatment - Drugs
2
Description
the platelet gel will be used once daily transrectaly in Intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgical Clinic of Shiraz University of Medical Sciences
Full name of responsible person
leila ghahramani, Assistant Professor of surgery
Street address
colorectal recerch center, shiraz univercity of medical scinces
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vice-Chancellery of Research,Dr Gholamreza Hatam
Street address
Shiraz university of pharmacy
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
Shiraz University of pharmacy, Shiraz University of Medical Sciences
Full name of responsible person
Akram Jamshidzadeh,pharm.D PhD
Position
Professor of Pharmacology
Other areas of specialty/work
Street address
Shiraz University of pharmacy- Akbar Abad
City
Shiraz
Postal code
Iran
Phone
+98 71 1230 6972
Fax
Email
colorectal2@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila ghahramani, Assistant Professor of surgery
Position
Assistant Professor of surgery
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
leila_ghahramani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences , Colorectal Research Center
Full name of responsible person
Salar Rahimikazerooni, MD
Position
doctor
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand street, shiraz
City
Shiraz
Postal code
Iran
Phone
+98 71 1230 6972
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)