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IRCT20201225049826N1 IRCT 2021-12-01 Shahid Beheshti University of Medical Sciences Impact of platelet-rich plasma on anal fissure Evaluating the effect of autologous platelet-rich plasma on the improvement of therapeutic effectiveness of the classic approach to anal 2021-06-22 anticipated 60 Complete https://irct.ir/trial/53242 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A ََAnal fissure. Intervention 1: 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. Intervention 2: 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. 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: 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 How to obtain: 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. Comments:
public Hamed Ebrahimibagha
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 h.ebrahimi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Adel Zeinalpour
Shahid Beheshti university of medical sciences, Arabi Ave, Daneshjoo Blvd, Velenjak
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2243 9770 adel.zeinalpour@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with anal fissure Consent for entering to the study 20 years no limit Both Patients with inflammatory bowel disease or other conditions which can cause secondary anal fissure Patients with diabetes Patients with immune deficiency K60 Fissure and fistula of anal and rectal regions Treatment - Other Treatment - Drugs 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. 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. 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. Shahid Beheshti University of Medical Sciences Approved 2021-06-28 Ethics Committee of Shahid Beheshti University of Medical Sciences Iran, Tehran Velenjak St. , Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)