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Evaluation of Platelet-Rich Plasma Injection in the Treatment of Acute Anal Fissure

Protocol summary

Study aim
Determining the effect of local injection of platelet-enriched plasma in the treatment of patients with acute anal fissure
Design
The clinical trial has a control group, parallel, randomized to 56 patients. Randomization is done using the blocking method (Explained in the randomization section).
Settings and conduct
Standard anal fissure treatment includes stool softeners, topical diltiazem, and topical lidocaine, and in addition to standard treatment, the intervention group will receive two local injections of autologous platelet-enriched plasma at the site of anal fissure with a 1-week interval. Follow-up of patients will be one week and one month after the second injection.
Participants/Inclusion and exclusion criteria
Patients with acute anal fissure (with symptoms less than 6 weeks) who are diagnosed by a surgeon with a history and physical examination. Patients with chronic fissure, fissure in atypical or multiple locations, inflammatory bowel disease, cancer, history of trauma, tuberculosis, immunodeficiency, sexually transmitted diseases, history of anorectal surgery, current and recent pregnancies are excluded.
Intervention groups
Patients with acute anal fissure who receive a topical injection of platelet-enriched plasma in addition to standard fissure anal treatment, including stool softner, topical diltiazem, and topical lidocaine.
Main outcome variables
Patients' pain is assessed with the VAS questionnaire. The surgeon will also evaluate the patient's defecation problems, constipation, bleeding, itching, and sores.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220220054071N1
Registration date: 2022-03-06, 1400/12/15
Registration timing: prospective

Last update: 2022-03-06, 1400/12/15
Update count: 0
Registration date
2022-03-06, 1400/12/15
Registrant information
Name
Amir Zamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5102 5000
Email address
amir.zamani.66@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-10-12, 1401/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Platelet-Rich Plasma Injection in the Treatment of Acute Anal Fissure
Public title
Platelet-Rich Plasma Injection in acute anal fissure treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute anal fissure (clinical presentation in less than 6 weeks)
Exclusion criteria:
Patients with anal fissures occurring in more than 6 weeks Patients with anal fissures in atypical locations Patients with multiple fissures Patients with inflammatory bowel disease cancer patients patients with sexually transmitted diseases history of anorectal surgery patients with immunodeficiency pregnancy patients with tuberculosis
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done by dividing included patients into some blocks of size 2n( 2,4,6,8 and...), then randomizing patients in each block will be done such that n patients are allocated to the experimental group and control group. then we will choose the blocks randomly. This method ensures equal treatment allocation within each block when the complete block is used.
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
2022-02-09, 1400/11/20
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.729

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
patient complaint about anal fissure
Timepoint
one week and one month after the second injection of PRP
Method of measurement
pain, bleeding during defecation, itching and the appearance of the wound from the surgeon's point of view

2

Description
patient pain
Timepoint
one week and one month after the second injection of PRP
Method of measurement
visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: : A group of patients with acute 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 3000 rpm for 8 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 Rooyagen Company. Raw materials are prepared from the same company.
Category
Treatment - Other

2

Description
Control group: Patients with acute anal fissure receiving standard anal fissure treatment including fecal emollients, topical deltiazem, and topical lidocaine.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Amir Zamani
Street address
Iran, Tehran, Makhsoos street, Loghman Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@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
Email
intl_office@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
Leila Vatuizade
Position
Genereal surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
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
leilavatuizade@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Zamani
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
amir.zamani.66@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Zamani
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
amir.zamani.66@gmail.com

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: Amir Zamani, Email: amir.zamani.66@gmail.com 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 determining the type of requested information to the email of the person in charge of correspondence, she will prepare the requested information and send it to the applicant within one month.
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