Comperative evaluation of Topical Diltiazem and Botulinum toxin injection in reducing postoperative complications following Millian-morgan Hemorrhoidectomy

Comparison of the effect of topical diltiazem and botox injection on reducing pain , incidence of headache , of fecal and gas incontenency , pruritus , rate of inability to attend work or school , use of systemic analgesic and reducing complication based on age and gender after Milligan–Morgan hemorrhoidectomy

A prospective, randomized, open‑label clinical trial was conducted on 66 patients. Randomization was performed using Stata software version 14.2 with the stsyntax command.

The patients will be evaluated based on three study groups in terms of pain and other complications, which have been included as secondary outcomes in the questionnaire, and will be assessed on postoperative days 1, 3, and 7 by a surgery resident.

All patient over 18 years of age with internal,External or mixed hemorrhoids of grade 3 or 4 diagnosed are candidates for Millian -Morgan hemorrhoidectomy exclude Grade I and II hemorrhoids; the presence of other perianal pathologies including fissure, fistula, and malignancy; thrombosed hemorrhoids; history of previous perianal surgery; need for concomitant sphincterotomy; history of ischemic heart disease; heart block; pregnancy; severe hypertension; orthostatic hypotension; current use of calcium channel blockers; history of allergy to botox; and poor general condition for anesthesia corresponding to class IV or V according to the American Society of Anesthesiologists (ASA) classification.

One third of the patients will be randomly assigned to receive topical diltiazem, another one third will undergo local botox injection, and in the remaining one third, as the control group, vaseline will be used as a placebo.

Comparison of the effect of topical diltiazem, as a low-cost and readily available method, with the more expensive Botox injection

simple randomization according to individal unit.Each patient will be assigned a number and then, using Stata software version 14.2, the following syntax will be applied: Using the command: set obs n (total number of samples), we create the required number of observations in the software, and then with the syntax: gen A = _n we generate a numbering variable called “A.” Next, using the syntax: sample n (total number of samples), count we perform randomization on the created samples. Finally, the first group (the first half of the patients) will receive topical diltiazem, and the remaining half will undergo local botox injection.

De-identified individual participant data (IPD) including primary and secondary outcome measures of the study.

Access will be available starting 6 months after the publication of the final results for a period of 2 years.

Access will be available starting 6 months after the publication of the final results for a period of 2 years.

For conducting meta-analyses or verifying study findings, provided that a validated scientific proposal is submitted and data confidentiality is maintained.

Corresponding Author (Fatemeh Kamalipor azad) via Email: (f.kamalipor@gmail.com)

Applicants must submit a brief proposal outlining the intended use of the data. After review and approval by the research team, the data will be shared within 2 to 4 weeks.