Comparing the modified surgical interventions with Probing, Turbinate fracture and Crowforded in treatment of congenital obstruction of nasolacrimal duct: a Randomized controlled clinical trial
Comparison of success rate in modified surgical intervention methods with probing method with turbine fracture and Crawford implantation in the treatment of congenital nasolacrimal duct obstruction
Design
4 arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
This study will evaluate 4 surgical treatments for the treatment of congenital obstruction of the pure nasolacrimal duct in children under 5 years of age at Farabi hospital. Patients will be examined and examined 4 times after entering the study, and finally, within 6 months after the treatment intervention, they will undergo a complete clinical examination and fluorescein test. The results of this test will be reported positively or negatively, so that the positive result of this test is equal to the openness of the duct and its negative is equivalent to the obstruction of the duct.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children under 5 years of age in whom the diagnosis of congenital nasolacrimal duct obstruction is definitive
Conditions of non-entry: having accompanying disorders in facial ossification, cleft palate (even hidden), developmental disorders or defects
Intervention groups
Patients underwent one of 4 different surgical intervention methods in the treatment of congenital nasolacrimal duct obstruction:
Nasolacrimal duct probing surgical intervention with lower nasal turbine rupture
And nasolacrimal duct probing surgery with Crawford implantation
By nasolacrimal duct probing surgery as a basic method
And nasolacrimal duct probing surgery with lower nasal turbine rupture and Crawford implantation as the gold standard method
Main outcome variables
Determining the appropriate surgical intervention method with the least invasiveness and the best effectiveness in the treatment of congenital nasolacrimal duct obstruction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220120053771N1
Registration date:2022-02-08, 1400/11/19
Registration timing:prospective
Last update:2022-02-08, 1400/11/19
Update count:0
Registration date
2022-02-08, 1400/11/19
Registrant information
Name
Sahel Soltani Shahgoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 1080
Email address
sahelsoltan93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the modified surgical interventions with Probing, Turbinate fracture and Crowforded in treatment of congenital obstruction of nasolacrimal duct: a Randomized controlled clinical trial
Public title
Success rate in the treatment of congenital nasolacrimal duct obstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pure type of congenital nasolacrimal duct obstruction,
Age under 5 years,
negative fluorosin test without underlying disease or other syndromic disorder,
without previous history of nasolacrimal duct intervention or manipulation.
Exclusion criteria:
Patient / parent dissatisfaction with the study,
uncontrollable infection,
underlying disease or limitation of anesthesia,
concomitant tumors or bleeding disorders,
concomitant disorders of facial ossification,
cleft palate (even (Secretly),
developmental disorders or defects,
problems related to the pituitary gland or Ratke sinus and other abnormalities of the midline of the face.
Age
To 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
164
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the patients with the ability to enter the study, a three-digit code will be assigned to each patient, which will introduce the patient in all stages of the study and replace his name and other identity details. Then, a data collection form will be completed for patients and written informed consent will be obtained. In the next stage, patients will be divided into one of 4 intervention groups based on the principles of randomization and blinding and using block randomization method. Patients and evaluators will be unaware of the type of intervention performed during the study and the principles of dual blindness will be observed. Randomization will be based on a predetermined list. May 164 patients will be divided into 4 groups based on sex blocks. The desired list will be prepared by Randlist software.
Blinding (investigator's opinion)
Double blinded
Blinding description
After determining the patients with the ability to enter the study, a three-digit code will be assigned to each patient, which will introduce the patient in all stages of the study and replace his name and other identity details. Patients and evaluators will be unaware of the type of intervention performed during the study and the principles of dual blindness will be observed.
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
Tehran university of medical sciences, Pour sina Ave, keshavarz Blv, Tehran
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2022-03-01, 1400/12/10
Ethics committee reference number
00000000
Health conditions studied
1
Description of health condition studied
Congenital obstruction of the nasolacrimal duct
ICD-10 code
H04.53
ICD-10 code description
Neonatal obstruction of nasolacrimal duct
Primary outcomes
1
Description
Comparison of success rate in modified surgical intervention methods with probing method with turbine fracture and Crawford implantation in the treatment of congenital nasolacrimal duct obstruction
Timepoint
patients will be examined for the success of the intervention as well as the complications of the interventionm, a day after the intervention,. At 3 months and 6 months after the surgery, patients will be re-evaluated for the visual system and fluorocin test will be performed, and the results of follow-up and examination at times 0, 3 and 6 (months) will be evaluated and compared.
Method of measurement
At each follow-up, patients will undergo a complete evaluation of the visual system and perform a fluorescein test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Nasolacrimal duct probing surgery with rupture of the lower nasal turbine
Category
Treatment - Surgery
2
Description
Intervention group: Nasolacrimal duct probing surgery with Crawford implantation
Category
Treatment - Surgery
3
Description
Intervention group: Nasolacrimal duct probing surgery as a basic procedure
Category
Treatment - Surgery
4
Description
Intervention group: Nasolacrimal duct probing surgery with lower nasal turbine fracture and Crawford implantation as the gold standard method
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
Sahel Soltani Shahgoli
Street address
Farabi hospital, South Kargar Ave, Qazvin Sqr
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5540 0003
Email
sahelsoltan93@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
South Kargar, Farabi hospital
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5540 0003
Email
sahelsoltan93@gmail.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
Sahel Soltani Shahgoli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Farabi hospital, South Kargar Ave, Qazvin Sqr
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5540 0003
Fax
Email
sahelsoltan93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sahel Soltani Shahgoli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Farabi hospital, South Kargar Ave, Qazvin Sqr
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5540 0003
Fax
Email
sahelsoltan93@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sahel Soltani Shahgoli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Farabi hospital, South Kargar Ave, Qazvin Sqr
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5540 0003
Fax
Email
sahelsoltan93@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
Yes - There is 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
Title and more details about the data/document
After the end of the study, the results of the study of the consequences and data analysis will be published in the form of an article with details and working methods.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
After printing the results, everyone will have access to the documents
Under which criteria data/document could be used
After printing the results, everyone will have access to the documents
From where data/document is obtainable
By sending an email to the responsible author
What processes are involved for a request to access data/document