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IRCT20130311012782N59 IRCT 2024-02-21 Esfahan University of Medical Sciences The effect of botox and Myctomy on the treatment of functional constipation Comparing the results of botox injection and myctomy in the treatment of children with functional constipation 2024-04-03 anticipated 64 Complete https://irct.ir/trial/75464 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients between two groups is done in a simple way. In this way, a number is written on the paper and placed inside the envelope according to the sample size. When the patient enters the operating room, the patient is asked to choose an envelope. Depending on whether the number is even or odd, the patient is placed in one of the two groups of mycotomy or botox injection, Blinding description: The study is double-blind, and the patients and the person assessing the outcome of the treatment will be unaware of the type of intervention performed. 3 Functional constipation. Intervention 1: Intervention group 1: Botox injection group. Intervention 2: Intervention group: Myctomy group. No - There is not a plan to make this available Justification or reason for not sharing IPD is The plan belongs to the government organization and it is not possible to share it
public Asadollah Rooshani
Imam Khomini street
Isfahan Iran (Islamic Republic of) 8434193474 +98 31 3669 2174 mar0922732@gmail.com Esfahan University of Medical Sciences scientific Mehrdad Hoseinpour
Imam Khomini street
Isfahan Iran (Islamic Republic of) 8434193474 +98 31 3699 2174 M_hoseinpour@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Children 4 to 16 years old Suffering from functional constipation Failure to respond to drug treatments Parents' willingness to participate in the study 4 years 16 years Both Presence of Sphincter achalasia Types of hieroshprung that have positive radiological findings Absence of ganglion in biopsy K59.09 Other constipation Treatment - Drugs Treatment - Surgery Intervention group 1: Botox injection group Intervention group: Myctomy group Constipation severity. Timepoint: Before and one year after treatment. Method of measurement: ROME III score. Fecal incontinence. Timepoint: Before and one year after treatment. Method of measurement: Rintala score. Complications of treatment (abscess, bleeding, pelvic muscle paralysis). Timepoint: One year after the treatment. Method of measurement: Through examination and history. Need for drug therapy. Timepoint: From after the intervention until one year later. Method of measurement: Through examination and history. Isfahan University of Medical Sciences Approved 2020-09-20 Ethics committee of Isfahan University of Medical Sciences Imam Khomini street Isfahan Isfehan Iran (Islamic Republic of)