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IRCT20130826014483N12 IRCT 2025-06-25 Mazandaran University of Medical Sciences The effect of intrasphincteric botox injection during hemorrhoidopexy with stapler on postoperative clinical outcomes of a double-blind clinical trial study The effect of intrasphincteric botox injection during hemorrhoidopexy with stapler on postoperative clinical outcomes of a double-blind clinical trial study 2025-06-30 anticipated 68 Complete https://irct.ir/trial/84312 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize the samples, we use a block method with six blocks. In this way, from the following blocks, one is first selected at random (for example, with a dice) and according to that order, we assign the samples to 2 groups. (For example, A for the Botox group and B for the placebo group) For example, if block three is selected, the first and second samples will be assigned to group B and the third and fourth samples to group A. And we make the assignment according to that and this process will continue until the end of the sampling. If a 35-year-old woman with a body mass index of 29 is in group A, there will be other patients with similar characteristics in the control group and no cut-off is defined for these values ​​and an attempt will be made to ensure that the patients in the two groups are similar with a reasonable and appropriate standard deviation in these variables, Blinding description: Due to the type of study design, patients and the study's conducting physicians were unaware of the intervention performed on the patients (Botox or placebo), and only the primary study analysts would be aware of the grouping of participants in the study. 3 Hemorrhoidopexy. Intervention 1: Intervention group: Botox solution manufactured by Masoon Darou Company from Iran in an amount of 0.4 ml as an injection at the site of the operation. Intervention 2: Control group: Placebo manufactured by Masoon Darou Company from Iran in an amount of 0.4 ml as an injection at the site of surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information available.
public Mina Alvandipour
Mina Alvandipour
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 malvandipour@mazums.ac.ir Mazandaran University of Medical Sciences scientific Mina Alvandipour
Imam Khomeini Medical Training Center, Amir Mazandarani Boulevard, Sari, Iran
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 malvandipour@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years of age Patients with symptomatic grade 3 or 4 hemorrhoids who are indicated for hemorrhoidectomy 18 years no limit Both Patients with inflammatory bowel disease Patients with fistula disease, Previous history of surgery in the anal area Patients with dermatitis, proctitis Patients with pregnancy-related illness Cardiovascular diseases Patients with severe respiratory illness Patients with cleft palate K64.2 Third degree hemorrhoids Treatment - Drugs Treatment - Drugs Intervention group: Botox solution manufactured by Masoon Darou Company from Iran in an amount of 0.4 ml as an injection at the site of the operation. Control group: Placebo manufactured by Masoon Darou Company from Iran in an amount of 0.4 ml as an injection at the site of surgery. Pain intensity. Timepoint: It will be coded at 6 and 12 hours after surgery and again on days 1, 2, 7, and 14 after surgery. Pain will also be assessed after the first to fifth bowel movements. Method of measurement: Visual Analogue Scale. Wound healing quality. Timepoint: After surgery, five check-ups will be performed every two weeks from day 30 to 4 months after surgery. Method of measurement: Information collection form. Mazandaran University of Medical Sciences Approved 2025-04-13 Imam Khomeini Medical Training Center, Amir Mazandarani Boulevard, Sari, Iran Imam Khomeini Medical Training Center, Amir Mazandarani Boulevard, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)