Protocol summary

Summary
The present study aims to evaluate the effect of silicone stent appliance in DCR through comparing it with conventional DCR. A target population of 50 patients is considered for this study. In this randomized clinical trial Patients with Nasolacrimal duct obstruction attending to Otolaryngology clinic of Baqiyatallah hospital will be assessed for eligibility. After confirmation of diagnosis by history taking, physical examination and Dacryocystography and signing a written informed consent form, patients will be randomly allocated to two groups regardless of age, gender and disease duration; group A patients will undergo endoscopic Dacryocystorhinostomy (DCR) with silicon stent and group B patients will undergo conventional endoscopic Dacryocystorhinostomy. Silicon stent will be removed one month after intervention. Etiology of disease and method of surgery will be explained for patients prior to intervention. Patients with previous DCR, Previous history of nasolacrimal duct surgery, not willing to participate in the study or concurrent sinus disease will be excluded from the study. Demographic and main complaints of patients will be recorded in a pre designed checklist. Patients in both groups will be evaluated for symptom resolution, peri and post operational complications such as bleeding, discharge, adhesion and punctuate granuloma formation in first and sixth months after intervention. In every visit patients will undergo diagnostic endoscopy in terms of obstruction evaluation and results will be recorded for each patient separately.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101717413N18
Registration date: 2016-10-24, 1395/08/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-24, 1395/08/03
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research in Baqiyatallah University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of outcome following Dacryocystorhinostomy with or without silicon stent appliance; a randomized clinical trial
Public title
Evaluating the effect of silicone stent application in Endoscopic Dacryocystorhinostomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Obstructive Etiology of Nasolacrimal duct Exclusion Criteria: Previous history of nasolacrimal duct surgery; Previous history of dacryocystorhinostomy; Not willing to participate
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
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
Baqiyatallah University of Medical Sciences
Street address
Nosrati Alley, Sheykh Bahaei Street, Mollasadra street, Vanaq Square, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-04-21, 1393/02/01
Ethics committee reference number
IR.BMSU.REC.1393.31

Health conditions studied

1

Description of health condition studied
Nasolacrimal Duct Obstruction
ICD-10 code
H04.5
ICD-10 code description
Stenosis and insufficiency of lacrimal passages

Primary outcomes

1

Description
Epiphora
Timepoint
first and sixth month after intervention
Method of measurement
History and Physical Examination

Secondary outcomes

1

Description
Duct Adhesion
Timepoint
First and Sixth Months after intervention
Method of measurement
Endoscopy

2

Description
Punctate granuloma
Timepoint
First and Sixth Months after intervention
Method of measurement
Endoscopy

Intervention groups

1

Description
Patients in intervention group will undergo endoscopic Dacryocystorhinostomy (DCR) with silicon stent application.
Category
Treatment - Surgery

2

Description
Patients in control group will undergo conventional endoscopic Dacryocystorhinostomy (without stent application)
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Mohammad Hossein Khosravi
Street address
Baqiyatallah Hospital, Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Morteza Izadi
Street address
Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheykh Bahaei st., Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran
Full name of responsible person
Mohammad Hossein Khosravi
Position
Secretary General
Other areas of specialty/work
Street address
Nosrati Alley, Sheykh Bahaei st, Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 0826
Fax
Email
dr.mhkhosravi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Baqiyatallah Universi
Full name of responsible person
Masoumeh Saeedi
Position
Otolaryngologist
Other areas of specialty/work
Street address
Nosrati Alley, Sheykh Bahaei st, Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 0826
Fax
Email
m.saeedi67@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Student Research Committee, Baqiyatallah University of medical sciences, Tehran, Iran.
Full name of responsible person
Mohammad Hossein Khosravi
Position
Secretary-General
Other areas of specialty/work
Street address
Nosrati Alley, Sheykh Bahaei st., Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 0826
Fax
Email
dr.mhkhosravi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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