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IRCT20220220054071N1 IRCT 2022-03-06 Shahid Beheshti University of Medical Sciences Platelet-Rich Plasma Injection in acute anal fissure treatment Evaluation of Platelet-Rich Plasma Injection in the Treatment of Acute Anal Fissure 2022-04-09 anticipated 56 Complete https://irct.ir/trial/62131 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 3 ََAnal fissure. Intervention 1: 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. Intervention 2: Control group: Patients with acute anal fissure receiving standard anal fissure treatment including fecal emollients, topical deltiazem, and topical lidocaine. Yes - There is a plan to make this available What will be shared: 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: 6 months after printing the results To whom: The information will be available to anyone who requests access Conditions: Data are provided to study the study process or use in systematic review studies and meta-analysis. Where to obtain: 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 How to obtain: 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. Comments:
public Leila Vatuizade
7th Floor, Bldg No.2 Shahid Beheshti university of medical sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2243 9770 leilavatuizade@yahoo.com Shahid Beheshti University of Medical Sciences scientific Amir Zamani
Shahid Beheshti university of medical sciences, Arabi Ave, Daneshjoo Blvd, Velenjak
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2243 9770 amir.zamani.66@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with acute anal fissure (clinical presentation in less than 6 weeks) no limit no limit Both 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 K60 Fissure and fistula of anal and rectal regions Treatment - Other Treatment - Other 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. Control group: Patients with acute anal fissure receiving standard anal fissure treatment including fecal emollients, topical deltiazem, and topical lidocaine. 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. Patient pain. Timepoint: one week and one month after the second injection of PRP. Method of measurement: visual analogue scale. Shahid Beheshti University of Medical Sciences Approved 2022-02-09 Ethics Committee of Shahid Beheshti University of Medical Sciences Iran, Tehran Velenjak St. , Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)