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IRCT20111229008554N4 IRCT 2018-05-05 Tehran University of Medical Sciences Effect of Electromotive Administration of Botox in Refractory Constipation Intrarectal Electromotive Botulinum Toxin Type A Administration In Children With Refractory Constipation 2017-12-22 anticipated 60 Complete https://irct.ir/trial/28186 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly allocated into two equal treatment groups in a balanced randomization study using random block sizes of 4 (ratio; 1:1). A computer-generated list of random numbers was used to allocate the participants, Blinding description: The outcome assessors were blinded. An independent person records the coded trial data in SPSS.An independent person analyzes the data. 3 Constipation. Intervention 1: Intervention group: Patients underwent electromotive botulinum toxin type A. Catheterization was performed with a 16-Fr electrode catheter, after providing a local intera -anal anesthesia with 2% lidocaine gel. The cuff of the catheter was filled by 2cc saline solution in order to fix the catheter in the rectum. The rectum was then drained and irrigated with 0.9% saline solution until the catheter outflow became clear. The rectum was subsequently filled with 30 cc sterile water and botulinum toxin A (Dysport, Ipsen, Paris, France) at a dose of 10-15 IU/kg was added to the intraanal solution. Negative electrode as two dispersive electrodes was placed parallel to the midline at the level of the umbilicus or Gluteal region with adequate contact gel. Positive electrode was connected to the intraanal catheter. The catheter electrodes were attached to a pulsed current generator and the device was adjusted to deliver a current with frequency of 2800 Hz, and amplitude of 10 mA for 20 minutes. This procedure was performedwithout anesthesia on outpatient basis. Intervention 2: Control group: After hospitalization,the 10-15 IU/kg botulinum toxin A (dysport) is injected intra-anal sphincter at 6 and 12 o'clock position in operation room under anesthesia, . Undecided - It is not yet known if there will be a plan to make this available
public Mohammadjavad Mohseni
No. 62, Dr. Qarib’s St, Keshavarz Blvd, Children's Medical Center
Tehran Iran (Islamic Republic of) 14194 33151 +98 21 6656 5400 mjmohseni.purc@gmail.com Tehran University of Medical Sciences scientific Abdol-Mohammad Kajbafzadeh
No. 62, Dr. Qarib’s St, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 14194 33151 +98 21 6656 5400 kajbafzd@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) The patient has constipation according to Rome III criteria No response to drug therapy No response to pelvic floor physical therapy 5 years 18 years Both The patient has neurological disorder The patient has anatomical disorder The patient has history of anal region or anal sphincter surgery K59.0 Constipatio Treatment - Drugs Treatment - Drugs Intervention group: Patients underwent electromotive botulinum toxin type A. Catheterization was performed with a 16-Fr electrode catheter, after providing a local intera -anal anesthesia with 2% lidocaine gel. The cuff of the catheter was filled by 2cc saline solution in order to fix the catheter in the rectum. The rectum was then drained and irrigated with 0.9% saline solution until the catheter outflow became clear. The rectum was subsequently filled with 30 cc sterile water and botulinum toxin A (Dysport, Ipsen, Paris, France) at a dose of 10-15 IU/kg was added to the intraanal solution. Negative electrode as two dispersive electrodes was placed parallel to the midline at the level of the umbilicus or Gluteal region with adequate contact gel. Positive electrode was connected to the intraanal catheter. The catheter electrodes were attached to a pulsed current generator and the device was adjusted to deliver a current with frequency of 2800 Hz, and amplitude of 10 mA for 20 minutes. This procedure was performedwithout anesthesia on outpatient basis Control group: After hospitalization,the 10-15 IU/kg botulinum toxin A (dysport) is injected intra-anal sphincter at 6 and 12 o'clock position in operation room under anesthesia, . Defecation frequency per week. Timepoint: At the 1 and 6 months later. Method of measurement: Filling out of bowel diary by parents. Tehran University of Medical Sciences Approved 2017-12-12 Ethics committee of Tehran University of Medical Sciences Ghods st., Blvd. Keshavarz, Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)