Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000552381
Ethics application status
Approved
Date submitted
21/09/2008
Date registered
30/10/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
effects of rhinoplasty on nasolacrimal duct
Scientific title
assessment of rhinoplasty effects on tear passage time through nasolacrimal duct using chloramphenicol eye drop bitter taste test
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rhinoplasty side effects on nasolacrimal duct 3731 0
Condition category
Condition code
Eye 3902 3902 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
closed rhinoplasty with lateral osteotomy and intranasal incicion over the inferior turbinate using 4mm osteotome with lateral guide
Intervention code [1] 3444 0
Treatment: Surgery
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4801 0
Tear passage time using chloramphenicol eye drop bitter taste test
Timepoint [1] 4801 0
before surgery,one week,one month,three months, six months
Secondary outcome [1] 8101 0
effects of sex and age in tear passage time after rhinoplsty assessed by chloramphenicol eye drop bitter taste test
Timepoint [1] 8101 0
before surgery,one week,one month,three months, six months

Eligibility
Key inclusion criteria
1-indication of rhinoplasty by otolaryngologists
2-no evidence of nasolacrimal duct obstruction before surgery in history,examinations,scintigraphy,nasolacrimal duct irrigation by normal saline,chloramphenicol eye drop bitter taste test
Minimum age
19 Years
Maximum age
37 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1-no sensation of taste in pre-surgery test
2-any evidence of lacrimal system disease in history ,examinations,scintigraphy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment outside Australia
Country [1] 1229 0
Iran, Islamic Republic Of
State/province [1] 1229 0

Funding & Sponsors
Funding source category [1] 3908 0
University
Name [1] 3908 0
shahed university
Country [1] 3908 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
mohammad ebrahim yarmohammadi
Address
mostafa khomeini hospital
italia st
tehran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 3506 0
Individual
Name [1] 3506 0
hassan ghassemi
Address [1] 3506 0
mostafa khomeini hospital
italia st
tehran
Country [1] 3506 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Rhinoplasty is one of the most common cosmetic surgeries. Lateral osteotomy is one of the surgical methods in rhinoplasty. There are several methods to determine the tear passage time through nasolacrimal duct (NLD) such as dacryocystography, dacryoscintigraphy, Taste test, etc.
One of the useful tests which can be used for determining of tear passage through NLD is dripping of chloramphenicol drop in the eye and recording the passage time by its bitter taste perception by the patient. It should be pointed out that this test is easy to do, inexpensive, accessible, and safe. there is a controversy in the effects of rheinoplasty on naso lacrimal duct system.
In this clinical trial study (before and after intervention), 37 patients (74 eyes) were examined. The chloramphenicol taste test was done one week before and one week, one month, three months, six month after Rhinoplasty. All the results have been statistically analyzed through paired T and other statistic test.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28963 0
Address 28963 0
Country 28963 0
Phone 28963 0
Fax 28963 0
Email 28963 0
Contact person for public queries
Name 12120 0
shahryar pourfarzam
Address 12120 0
mostafa khomeini hospital
Italia street
tehran
Country 12120 0
Iran, Islamic Republic Of
Phone 12120 0
+982188963122
Fax 12120 0
+982188963122
Email 12120 0
sh.pourfarzam@gmail.com
Contact person for scientific queries
Name 3048 0
mohammad ebrahim yarmohammadi
Address 3048 0
mostafa khomeini hospital
Italia street
tehran
Country 3048 0
Iran, Islamic Republic Of
Phone 3048 0
+982188963122
Fax 3048 0
+982188963122
Email 3048 0
meyarmohammadi@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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