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
Determining the effect of botox injection in the internal anal sphincter under ultrasound guidance with a surface probe and without ultrasound in children with constipation
Design
The clinical trial, with parallel groups, double-blind, randomized on 40 children
Settings and conduct
In this randomized double-blind clinical trial study, 40 children with constipation referred to Imam Hossein Isfahan Hospital will be included in the study and will be randomly divided into two groups. One group will undergo Botox injection with ultrasound guidance and the other group will undergo Botox injection without ultrasound guidance. Then the improvement of constipation and fecal incontinence of the patients will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include children over 3 years old with constipation; failure to respond to treatment; the presence of tuberculous ganglion in the rectal biopsy; no contraindications for botox injection; consent to participate in the study.
Exclusion criteria: having constipation caused by Hirschbrung; taking aminoglycoside drugs; penicillamine, quinine, and calcium channel blockers and having neuromuscular junction diseases.
Intervention groups
The intervention group, in this group, botox injection in the sphincter of the patients will be determined by ultrasound with a surface probe in the anus, proximal to the internal sphincter, and 25 units of botulinum toxin type A will be injected in each part.
The control group, in this group, without the use of ultrasound and only by touch with the index finger, botox injection will be performed similar to the first group (in terms of amount, injection location and type of botulinum toxin).
Main outcome variables
Improvement of constipation; fecal incontinence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230704058661N1
Registration date:2023-09-27, 1402/07/05
Registration timing:prospective
Last update:2023-09-27, 1402/07/05
Update count:0
Registration date
2023-09-27, 1402/07/05
Registrant information
Name
Masoud Nazem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 1995
Email address
m_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The outcome of Botox injection in the internal anal sphincter with and without ultrasound guided in children with constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Constipation caused by Hirschbrung
Taking aminoglycoside drugs, penicillamine, quinine, and calcium channel blockers
Having neuromuscular junction diseases such as myasthenia gravis
Age
From 3 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2019-08-06, 1398/05/15
Ethics committee reference number
IR.MUI.MED.REC.1398.249
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Improvement of constipation
Timepoint
Two weeks, one and three months after botox injection
Method of measurement
Biography of the child's parents
2
Description
Fecal incontinence
Timepoint
Two weeks, one and three months after botox injection
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital in Isfahan
Full name of responsible person
Mehrdad Hosseinpour
Street address
Imam Khomeini street
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
meh_hosseinpour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Nazem
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Imam Hossein Hospital, Imam Khomeini Street.
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
m_nazem@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Hosseinpour
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Imam Hossein Hospital, Imam Khomeini Street.
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Fax
Email
meh_hosseinpour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gilda Majdnasiri
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Hossein Hospital, Imam Khomeini Street.
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
majdnasiri@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD