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IRCT20241022063459N1 IRCT 2026-09-22 Tehran University of Medical Sciences Comparison of Topical Diltiazem and Botox injection in reducing postoperative complication after Millian-Morgan Hemorrhoidectomy Comperative evaluation of Topical Diltiazem and Botulinum toxin injection in reducing postoperative complications following Millian-morgan Hemorrhoidectomy 2026-09-21 anticipated 66 Recruiting https://irct.ir/trial/86883 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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. 3 hemorrhoid grade 3 and 4 - perianal disease. Intervention 1: Intervention group: Botulinum Toxin Group.Patients in this group received an injection of Botulinum Toxin type A. The toxin was injected into the targeted muscles of the anal sphincter using a standardized dose and technique, as per the surgical protocol. Intervention 2: Intervention group: Diltiazem Group.Patients in this group were treated with Diltiazem topical gel. The gel was applied topically to the anal area according to the prescribed frequency and dosage as per the surgical protocol. Intervention 3: Control group: Vaseline Group.Patients in this group received sterile Vaseline as a placebo. It was applied topically to the anal area using the same frequency and technique as the Diltiazem gel group to maintain blinding. Yes - There is a plan to make this available What will be shared: De-identified individual participant data (IPD) including primary and secondary outcome measures of the study. When: Access will be available starting 6 months after the publication of the final results for a period of 2 years. To whom: Access will be available starting 6 months after the publication of the final results for a period of 2 years. Conditions: For conducting meta-analyses or verifying study findings, provided that a validated scientific proposal is submitted and data confidentiality is maintained. Where to obtain: Corresponding Author (Fatemeh Kamalipor azad) via Email: (f.kamalipor@gmail.com) How to obtain: 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. Comments:
public Fatemeh Kamali pour azad
Sina Hospital, Hassan Abad Square, Imam Khomeini St., Tehran, Iran
Tehran Iran (Islamic Republic of) 1136746911 +98 21 7774 5519 f.kamalipor@gmail.com Tehran University of Medical Sciences scientific Fatemeh Kamali pour azad
Sina Hospital, Hassan Abad Square, Imam Khomeini St., Tehran, Iran
Tehran Iran (Islamic Republic of) 1136746911 +98 21 7774 5519 f.kamalipor@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) All patient over 18 years of age with internal,External or mixed hemorrhoids of grade 3 or 4 diagnosed according the classification of the American Society of Colon and rectal surgeons ,who are candidates for Millian -Morgan hemorrhoidectomy 18 years no limit Both grade 1 and 2 hemorrhoid presence of other perianal pathologies including fissure,fistula and malignancy Thrombosed hemorrhoids history of perianal surgery need for concomitant sphincterotomy history of ischemic heart disease Heart block pregnancy sever hypertension orthostatic hypotension current use of calcium channel blockers history of allergy to botox poor general condition for general anesthesia corresponding to class 4 or 5 according to American Society of Anesthesiologists (ASA) classification K64 Hemorrhoids and perianal venous thrombosis Treatment - Drugs Treatment - Drugs Placebo Intervention group: Botulinum Toxin Group.Patients in this group received an injection of Botulinum Toxin type A. The toxin was injected into the targeted muscles of the anal sphincter using a standardized dose and technique, as per the surgical protocol. Intervention group: Diltiazem Group.Patients in this group were treated with Diltiazem topical gel. The gel was applied topically to the anal area according to the prescribed frequency and dosage as per the surgical protocol. Control group: Vaseline Group.Patients in this group received sterile Vaseline as a placebo. It was applied topically to the anal area using the same frequency and technique as the Diltiazem gel group to maintain blinding. Postoperative resting pain intensity measured by the Visual Analogue Scale (VAS). Timepoint: post operative days 1,3and 7. Method of measurement: Pain intensity was assessed by the patient on a 10-cm linear Visual Analogue Scale (VAS), where 0 represents "no pain" and 10 represents "worst possible pain. Postoperative defecation-related pain intensity measured by the Visual Analogue Scale. Timepoint: post operative days 1,3and 7. Method of measurement: Pain intensity was assessed by the patient on a 10-cm linear Visual Analogue Scale , where 0 represents "no pain" and 10 represents "worst possible pain. Total dose of Non-Steroidal Anti-Inflammatory Drugs consumed postoperatively. Timepoint: during the first seven days postoperatively. Method of measurement: The total number of doses of Non-Steroidal Anti-Inflammatory Drugs consumed by the patient during the first week after surgery was recorded using a patient data collection form. Total Morphine Equivalent Dose of opioids consumed. Timepoint: during the first seven days postoperatively. Method of measurement: Total opioid consumption was recorded and converted into the Morphine Equivalent Dose for standardization, using a standardized. Incidence of postoperative complications including headache, bleeding, pruritus, and fecal or gas incontinence. Timepoint: during the first seven days postoperatively. Method of measurement: The occurrence of each complication was evaluated by a surgical resident and recorded as present or absent in the patient's record. Postoperative functional outcome measured by the Wexner score. Timepoint: On postoperative day 7. Method of measurement: The Wexner scoring system was used to evaluate the level of fecal continence, assessing the frequency of accidents and the use of pads. Number of days absent from work or education following surgery. Timepoint: From the day of surgery until the return to regular activities. Method of measurement: The total number of days the patient was unable to return to their occupational or educational activities was recorded based on patient self-reporting. Tehran University of Medical Sciences Approved 2024-10-19 Ethics committee of Tehran university of medical sciences No 20 , 130 th (jafar bye)street , Rashid street , Tehranpars , Tehran Tehran Tehran Iran (Islamic Republic of)