To investigate the effect of electromotive botulinum toxin type A administration in patients with refractory constipation
Design
Sixty patients with refractory constipation were enrolled in the study. Patients were randomly allocated into two equal treatment groups in a balanced randomization study using random block sizes of 4 (ratio; 1:1).
Settings and conduct
Pediatric Urology and Regenerative Medicine Research Center
Participants/Inclusion and exclusion criteria
Inclusion criteria: Refractory constipation according to Rome III criteria, no response to drug therapy
Exclusion criteria: Neurological disorder, anatomical disorder, history of anal region or anal sphincter surgery
Intervention groups
In group one, 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 type A at a dose of 10-15 IU/kg was added to the intra anal 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 intra-anal 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. Control group: After hospitalization, , the 10-15 IU/kg botulinum toxin type A is injected intra-anal sphincter at 6 and 12 o'clock position in operation room under anesthesia
Main outcome variables
Defecation frequency per week
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111229008554N4
Registration date:2018-05-05, 1397/02/15
Registration timing:registered_while_recruiting
Last update:2018-05-05, 1397/02/15
Update count:0
Registration date
2018-05-05, 1397/02/15
Registrant information
Name
Abdol-mohammad Kajbafzadeh
Name of organization / entity
pediatric urology and reconstructive medicine research center
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 5400
Email address
kajbafzd@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intrarectal Electromotive Botulinum Toxin Type A Administration In Children With Refractory Constipation
Public title
Effect of Electromotive Administration of Botox in Refractory Constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has constipation according to Rome III criteria
No response to drug therapy
No response to pelvic floor physical therapy
Exclusion criteria:
The patient has neurological disorder
The patient has anatomical disorder
The patient has history of anal region or anal sphincter surgery
Age
From 5 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
1
The patient with refractory constipation
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
The outcome assessors were blinded. An independent person records the coded trial data in SPSS.An independent person analyzes the data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ghods st., Blvd. Keshavarz, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14194 33151
Approval date
2017-12-12, 1396/09/21
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4232
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipatio
Primary outcomes
1
Description
Defecation frequency per week
Timepoint
At the 1 and 6 months later
Method of measurement
Filling out of bowel diary by parents
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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, .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Abdol-Mohammad Kajbafzadeh
Street address
No. 62, Dr. Qarib’s St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194 33151
Phone
+98 21 6656 5400
Email
kajbafzd@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Tehran University of Medical Sciences, Ghods st., Blvd. Keshavarz
City
Tehran
Province
Tehran
Postal code
14194 33151
Phone
+98 21 8163 3686
Email
sahraian1350@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadjavad Mohseni
Position
Manager
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No. 62, Dr. Qarib’s St, Keshavarz Blvd, Children's Medical Center
City
Tehran
Province
Tehran
Postal code
14194 33151
Phone
+98 21 6656 5400
Fax
+98 21 6656 5500
Email
mjmohseni.purc@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abdol-Mohammad Kajbafzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
No. 62, Dr. Qarib’s St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194 33151
Phone
+98 21 6656 5400
Email
kajbafzd@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadjavad Mohseni
Position
Manager
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No. 62, Dr. Qarib’s St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194 33151
Phone
+98 21 6656 5400
Fax
+98 21 6656 5500
Email
mjmohseni.purc@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available