The effect of intrasphincteric botox injection during hemorrhoidopexy with stapler on postoperative clinical outcomes of a double-blind clinical trial study

The effect of intrasphenobarbital botulinum toxin injection during hemorrhoidopexy on postoperative clinical outcomes.

A controlled, double-blind, randomized, phase3 clinical trial with parallel groups on 68 patients. The rand function of Excel software was used for randomization.

This study is designed as a prospective, double-blind clinical trial, and placebo (normal saline) and Botox will be drawn into a syringe and prepared by a surgeon's assistant at Imam Khomeini Hospital in Sari and Shafa Hospital in Sari in 1404. Due to the type of study design, patients and the attending physicians conducting the study will not be aware of the intervention performed on the patients (Botox or placebo), and only the primary analysts of the study will be aware of the grouping of participants in the study.

Inclusion criteria: Patients over 18 years of age with symptomatic grade 3 or 4 hemorrhoids who have an indication for hemorrhoidectomy will be included in the study. Exclusion criteria: Patients with inflammatory bowel disease, fistula, fissure, and history of previous surgery in the anal area, dermatitis, proctitis, pregnancy, and severe cardiovascular or respiratory diseases will be excluded from the study.

Intervention group: Botox solution manufactured by Masoon Darou Company from Iran in an amount of 0.4 ml, injected at the site of surgery. Control group: Placebo manufactured by Masoon Darou Company from Iran in an amount of 0.4 ml, injected at the site of surgery.

The primary outcome measures were pain intensity at rest and during defecation, which will be scored based on VAS by a surgical resident at 6 and 12 hours and again on days 1, 2, 7, and 14 after surgery. Pain will also be assessed after the first to fifth defecation.

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.

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.