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IRCT20230704058661N1 IRCT 2023-09-27 Esfahan University of Medical Sciences The outcome of Botox injection in the internal anal sphincter with and without ultrasound guided in children with constipation Comparison of the outcome of botulinum toxin injection in internal anal sphincter under ultrasound guided with surface probe and without ultrasound in children with constipation 2023-10-23 anticipated 40 Complete https://irct.ir/trial/72019 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 40 eligible children will be randomly selected. For this, the letter A is written on 20 sheets, and the letter B is written on 20 sheets and each of them is placed in an envelope. Each children is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups, Blinding description: According to the difference in Botox injection method with and without ultrasound guide, the intervenor is aware of the type of intervention. However, the patient and the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention. 3 Constipation. Intervention 1: Intervention group: In this group, botox injection in the sphincter of patients with ultrasound (ultrasound HONDA ELECTRONICS model HS-2600) with a surface probe (7.5 MHz) in the anus, proximal internal sphincter at 3, 6 and 9 o'clock in the lithotomy position. And 25 units of botulinum toxin type A Dysport will be injected in each part. Intervention 2: Control group, in this group, botox injection will be performed without using sonography and only by touch with the index finger, similar to the first group (in terms of amount, injection location and type of botulinum toxin). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Masoud Nazem
Imam Hossein Hospital, Imam Khomeini Street.
Isfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 m_nazem@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mehrdad Hosseinpour
Imam Hossein Hospital, Imam Khomeini Street.
Esfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 meh_hosseinpour@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children over 3 years old with constipation Failure to respond to medical treatment and lifestyle changes by gastroenterologists The typical Hirschsprung appearance is not seen in the barium enema Presence of tuberculous ganglion in rectal biopsy No contraindications for botox injection Consent to participate in the study 3 years no limit Both Constipation caused by Hirschbrung Taking aminoglycoside drugs, penicillamine, quinine, and calcium channel blockers Having neuromuscular junction diseases such as myasthenia gravis K59.0 Constipation Treatment - Drugs Treatment - Drugs Intervention group: In this group, botox injection in the sphincter of patients with ultrasound (ultrasound HONDA ELECTRONICS model HS-2600) with a surface probe (7.5 MHz) in the anus, proximal internal sphincter at 3, 6 and 9 o'clock in the lithotomy position. And 25 units of botulinum toxin type A Dysport will be injected in each part. Control group, in this group, botox injection will be performed without using sonography and only by touch with the index finger, similar to the first group (in terms of amount, injection location and type of botulinum toxin). Improvement of constipation. Timepoint: Two weeks, one and three months after botox injection. Method of measurement: Biography of the child's parents. Fecal incontinence. Timepoint: Two weeks, one and three months after botox injection. Method of measurement: Observation. Isfahan University of Medical Sciences Approved 2019-08-06 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)