Evaluation of the effect of using autologous platelet-rich plasma (Autologous PRP) in improving the therapeutic effect of the classical approach to anal fissure
Design
The clinical trial has a control group, parallel, randomized to 60 patients. Randomization is done using the blocking method
Settings and conduct
First, for patients who have been diagnosed with acute or chronic anal fissure, the research plan is explained and after signing the informed consent, they enter to the study. Demographic information, history and systematic physical examination are obtained from patients.
Then patients are divided into two groups of intervention and control. Patients in the intervention group, while receiving classical treatment (nitroglycerin / nifedipine and topical lidocaine), refer to Shahid Modarres Hospital for injection of platelet-rich plasma twice in two weeks. For this purpose, blood samples are taken from patients and PRP is obtained from the blood received. The patient is then transferred to an outpatient operating room and under local anesthesia in a dorsal lithotomy position at the base of the wound PRP injection. The same procedure is repeated two weeks later, during which time the patient is followed up by telephone every 7 days. Two weeks after last injection, the patient goes to the surgery clinic of the Hospital for examination.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with anal fisher
Exclusion criteria: diabetes, immunodeficiency
Intervention groups
A group of patients with anal fissure who, in addition to the classic treatment, receive PRP as an injection at the base of the wound.
Main outcome variables
Change in pain, bleeding, itching and burning based on the patient's self-expression
Wound evaluation based on the surgeon's opinion during the examination.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201225049826N1
Registration date:2021-12-01, 1400/09/10
Registration timing:registered_while_recruiting
Last update:2021-12-01, 1400/09/10
Update count:0
Registration date
2021-12-01, 1400/09/10
Registrant information
Name
Hamed Ebrahimibagha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 9770
Email address
h.ebrahimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of autologous platelet-rich plasma on the improvement of therapeutic effectiveness of the classic approach to anal
Public title
Impact of platelet-rich plasma on anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with anal fissure
Consent for entering to the study
Exclusion criteria:
Patients with inflammatory bowel disease or other conditions which can cause secondary anal fissure
Patients with diabetes
Patients with immune deficiency
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, in order to balance the number of samples in each group, the blocking method (with unequal sizes of 2, 4 and 6) will be used for random allocation.
In this method, first the list of all permutations related to the desired block sizes is determined and then it is randomly selected according to the number of samples of permutations. Given that preparing a list of all permutations will take time. Random generation and selection of permutations is done using programming or reputable sites to generate a block randomization list.
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
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
198353-5511
Approval date
2021-06-28, 1400/04/07
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.190
Health conditions studied
1
Description of health condition studied
ََAnal fissure
ICD-10 code
K60
ICD-10 code description
Fissure and fistula of anal and rectal regions
Primary outcomes
1
Description
Incidence of wound healing
Timepoint
Initiation of the study, two weeks after injection, four weeks after injection, one month after the first injection
Method of measurement
Depending on the amount of pain, bleeding during defecation, itching and the appearance of the wound from the surgeon's point of view
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group of patients with anal fissures who, in addition to the classic treatment, receive PRP as an injection at the base of the wound. In order to prepare PRP or platelet-rich plasma, the patient is first given intravenous blood samples and tubes containing anticoagulants, citric acid, dextrose and thrombin are filled. The tubes are centrifuged at 1600 rpm for 12 minutes and platelet-rich plasma is collected using angiocatheter and platelet separation from the buffer coat. Then between 3 and 5 cc of PRP is injected into the syringe. 0.1 cc is injected at a distance of half a centimeter of healthy tissue into the wound each time. Classical therapy includes topical nitroglycerin, nifedipine, and lidocaine, which are routinely used for this purpose. The centrifuge used is an 8-branch model of 4000 rpm made by Alminogster Company. Raw materials are prepared from Noavaran Salamat Arjang Company to prepare PRP.
Category
Treatment - Other
2
Description
Control group: A group of patients with anal fissure who actually receive only classical treatment and are examined for comparison with the intervention group. Classical therapy includes topical nitroglycerin, nifedipine, and lidocaine, which are routinely used for this purpose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres hospital
Full name of responsible person
Adel Zeinalpour
Street address
Saadat Abad St.,Yadegare Imam Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Fax
+98 21 2207 4101
Email
pr_modaress@sbmu.ac.ir
Web page address
http://modarres.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Bldg No.2, Shahid Beheshti university of medical sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Fax
+98 21 2243 3455
Email
Intl_office@sbmu.ac.ir
Web page address
http://research.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamed Ebrahimibagha
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
7th Floor, Bldg No.2 Shahid Beheshti university of medical sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
h.ebrahimi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Adel Zeinalpour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti university of medical sciences, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
adel.zeinalpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamed Ebrahimibagha
Position
Medical Intern- Researcher
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
7th Floor, Bldg No.2 Shahid Beheshti university of medical sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Post Code: 19839-63113
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Fax
Email
h.ebrahimi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Participants' data file, study protocol, statistical analysis map, informed consent form and clinical study report will all be fully shareable after disclosing personal information.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
The information will be available to anyone who requests access
Under which criteria data/document could be used
Data are provided to study the study process or use in systematic review studies and meta-analysis.
From where data/document is obtainable
correspondence: Hamed Ebrahimibagha,
Email: h.ebrahimi@sbmu.ac.ir
Address: School of Medicine ,Shahid Beheshti University of Medical Sciences, Yemen St., Shahid Chamran Highway, Tehran ,Iran
Postal Code: 1985717443
What processes are involved for a request to access data/document
After sending the request for access to information and specifying the type of requested information to the email of the person in charge of correspondence, they will prepare the requested information and send it to the applicant.