Determining the effect of early repeated dilatations in the prevention of esophageal stricture in children with caustic substance ingestio
Design
Clinical trial, parallel groups, phase 3, on 30 patients. The randomization will be done by the random number table method through the website http//www.graphpad.com/quickcalcs/index.cfm.
Settings and conduct
This study will be conducted with the aim of determining the effect of early repeated dilatations in preventing esophageal stricture in children with caustic ingestion in Akbar Hospital, Mashhad. One group of patients undergo endoscopy and dilatation of esophageal stricture by endoscopic method every week for five sessions and the patients in the other group, like the patients in the previous group, undergo endoscopy and dilatation of the esophageal stricture by endoscopic method for five sessions at intervals of two weeks. Disease symptoms will be assessed at the beginning and end of the intervention through endoscopy. The names of the groups will be recorded as A and B in the data sheet.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Caustic esophageal stricture based on barium swallow study or clinical examination, Consent for participation by the patient or his guardian. Exclusion criteria: Normal upper GI.
Intervention groups
Intervention group1: Patients in the intervention group1 undergo endoscopy and dilatation of esophageal stricture by endoscopic method every week for five sessions. Intervention group2: The patients of the Intervention group2, like the patients of the intervention group1, undergo endoscopy and dilatation of the esophageal stricture by endoscopic method for five sessions at intervals of two weeks.
Main outcome variables
The main outcome variable will be esophageal dilatation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230410057870N1
Registration date:2023-05-03, 1402/02/13
Registration timing:prospective
Last update:2023-05-03, 1402/02/13
Update count:0
Registration date
2023-05-03, 1402/02/13
Registrant information
Name
Nadia Danaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3332 1078
Email address
danaein4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of early repeated dilatations in the prevention of esophageal stricture in children with caustic substance ingestion
Public title
Effect of early repeated dilatations in the prevention of esophageal stricture with caustic substance ingestion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Caustic esophageal stricture based on barium swallow study or clinical examination
Consent for participation by the patient or his guardian
Exclusion criteria:
Upper GI normality
Age
From 2 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups, dilation once a week and once every two weeks. Random numbers table is used for randomization. In order to use random numbers table, it will be determined first to read the numbers in the table, then the numbers are considered for different groups. We put our hands on one of the numbers and move in one of the predetermined directions and assign the numbers to the desired groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
34591375
Approval date
2022-10-24, 1401/08/02
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.704
Health conditions studied
1
Description of health condition studied
Caustic esophageal stricture
ICD-10 code
T28.1
ICD-10 code description
Burn of esophagus
Primary outcomes
1
Description
Dilatation
Timepoint
Every weeks after starting the study
Method of measurement
Endoscopy
Secondary outcomes
1
Description
Dysphagia
Timepoint
Once every week
Method of measurement
Endoscopy
Intervention groups
1
Description
Intervention group1: Patients in the intervention group1 undergo endoscopy and dilatation of esophageal stricture by endoscopic method every week for five sessions.
Category
Treatment - Other
2
Description
Control group2: The patients of the control group2, like the patients of the intervention group1, undergo endoscopy and dilatation of the esophageal stricture by endoscopic method for five sessions at intervals of two weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Hospital
Full name of responsible person
Nadia Danaee
Street address
Akbar Hospital, Kaveh Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3801
Email
Danaein4001@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayouri Mobarhan
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
34591375
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Nadia Danaee
Position
Fellows in Training
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Hospital, Kaveh Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3801
Email
Danaein4001@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nadia Danaee
Position
Fellows in Training
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Hospital, Kaveh Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3801
Email
Danaein4001@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nadia Danaee
Position
Fellows in Training
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Hospital, Kaveh Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3801
Email
Danaein4001@mums.ac.ir
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