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IRCT20231201060234N1 IRCT 2024-06-22 CMH Peshawar Medical versus surgical treatment for chronic anal fissure Comparison between treatment efficacy of glyceryl trinitrate and lateral sphincterotomy for chronic anal fissure 2023-01-01 anticipated 240 Complete https://irct.ir/trial/74506 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization was done using individual type. The method used was chits marked X and Y using the lottery method. The sealed chits were selected once the patient entered the recovery room. The resident surgeon deputed for patient selection of the chits was unaware of the study protocol and allocation concealment was done. Only the consultant in the operating room was aware of the protocol, Blinding description: Both the final assessor and data analyzer were unaware of the study protocol. 1-2 Chronic anal fissure. Intervention 1: Intervention group 1: Surgical lateral sphincterotomy group. Patients in Group S received the surgical procedure by a consultant surgeon and part of the internal anal sphincter was dissected to relieve the fissure induced spasm and were followed up till 8 weeks at 4,6 and 8 week duration for the primary and secondary outcomes mentioned. Intervention 2: Intervention group 2: Glyceryl trinitrate group.Patients received 0.2% ointment of glyceryl trinitrate and directed by a resident surgeon on its correct application in the perianal area using 1-2 ml twice a day for a total of 8 weeks and followed up similarly at 4,6 and 8 weeks duration. Yes - There is a plan to make this available What will be shared: All the data including patients records (excluding patient identification IDs), excel sheets, analysis proformas and SPSS output sheets will be made available to all researchers for academic purposes when requested through online repository, link of which will be shared once approval given from the primary author and the institute in which the study was carried out When: Will be available indefinitely pending approval by the primary author and institute To whom: For academic purposes only Conditions: The manuscript along with SPSS data sets and output sheets will be shared once published by the journal Will be shared via email Where to obtain: Will be sent both my email and will be available online and link would be provided as well on Google Drive How to obtain: Email to the institute and the primary author Comments:
public Rashid Ali
D7
Peshawar Pakistan 25000 +92 81 2850639 Rashid_zahidbaloch@hotmail.com CMH Peshawar scientific Rashid Ali
D7
Peshawar Pakistan 25000 +92 81 2850639 Rashid_zahidbaloch@hotmail.com CMH Peshawar Pakistan Patients more than 18 years of age With a chronic non-healing anal fissure more than 8 weeks duration Presenting to the surgical out-patient department for treatment. 18 years no limit Both Pregnancy Recurrent anal fissures Major cardiac or respiratory disease Unwilling to be included in the study K60.1 Chronic anal fissure Treatment - Surgery Treatment - Drugs Intervention group 1: Surgical lateral sphincterotomy group. Patients in Group S received the surgical procedure by a consultant surgeon and part of the internal anal sphincter was dissected to relieve the fissure induced spasm and were followed up till 8 weeks at 4,6 and 8 week duration for the primary and secondary outcomes mentioned. Intervention group 2: Glyceryl trinitrate group.Patients received 0.2% ointment of glyceryl trinitrate and directed by a resident surgeon on its correct application in the perianal area using 1-2 ml twice a day for a total of 8 weeks and followed up similarly at 4,6 and 8 weeks duration. Mean time to complete fissure healing. Timepoint: Assessed weekly after intervention till endpoint of healing or failure of healing after 8 weeks. Method of measurement: Subjective assessment by a surgical consultant. Median pain scores. Timepoint: Weekly will 8 weeks. Method of measurement: Visual analog pain score by a surgical consultant. Episodes of bleeding post-procedure. Timepoint: Weekly for 8 weeks after procedure. Method of measurement: Assessment subjectively by.a consultant surgical specialist. CMH Peshawar Approved 2023-02-07 Ethical Review board CMH Peshawar Mall road; Peshawar Peshawar KPK Pakistan