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