Comparing results of primary endoscopic Dacryocystorhinostomy (DCR) surgery with and without silicon stenting in patients with epiphora

Comparing of the results of primary endoscopic dacryocystorhinostomy surgery with and without silicon stenting in patients with epiphora

Clinical trial with control group, with parallel group, double-blind, randomized on 72 patients.

72 patients who have referred to the department of AmirAl-Momenin hospital in Rasht with diagnosis of primary acquired lacrimal duct obstruction are randomly divided into 2 groups. Both groups will be operated on endoscopically by a specific surgeon.The first postoperative visit will take place in the first week and then in months 1st, 3th, 6th and 12th. All the studied outcomes are examined in all visits.The blinding method was such that during the study period, the surgeon and patients did not have access to random numbers in each block .

Inclusion Criteria: Patients 18 years of age and older with persistent epiphora or recurrent ocular discharge with primary diagnosis of acquired nasolacrimal duct obstruction. Exclusion Criteria: previous history of nasolacrimal duct surgery؛ suspicion of lacrimal sac malignancy؛ canalicular obstruction requires membranectomy؛ presence of punctum and eyelid ectropion and facial nerve palsy and lid lag؛ history of radiotherapy and trauma and important disease in examined side of the nose and orbit؛ immunodeficiency and uncontrolled systemic diseases؛ congenital dacryocystitis؛ presence of abnormal bleeding disorders.

The intervention group undergoing endoscopic DCR surgery with a stent and the control group undergoing endoscopic DCR surgery without a stent.

Improvement of symptoms; nasolacrimal duct and ostium opening; No dacryocystitis

Due to the outbreak of the COVID-19 disease, the number of patients referred for DCR surgery decreased significantly, and due to the presence of the oculoplastic specialist, the number of patients referred to the ENT department decreased significantly. As a result, with the decision of the researchers, by changing the diagnostic accuracy of the study from 0.1 to 0.15, the sample size was reduced to 36 people in each group. This change was approved by the university's research committee.

After obtaining the informed consent, the mentioned patients are randomly are divided into two groups with and without stenting for surgery. Block randomization method is used to divide patients using of PASS Software. Randomization is performed by a researcher who is not involved in the clinical stages of project. In this method, 72 patients are randomly divided into 9 blocks, with 4 patients in each block, of which 2 are operated with a stent and 2 without a stent. The order of placement of these 4 patients in each block Is also determined randomly. In cases of bilateral lacrimal duct obstruction, each eye is randomized separately. The first group will undergo endoscopic DCR surgery with a stent and second group will have no stent surgery by a specific surgeon. The blinding method was such that during the study, the surgeon and patients did not have access to random numbers in each block.

During the study period, the surgeon and patients did not have access to random numbers in each block . Also evaluation in months 1, 3, 6 and 12 by a resident who was unaware of allocation of individuals to the two groups.

after the end of the study period

after the end of the study period

After the end of the study period, the results will be available to the public in the form of articles

If published as an article

ENT Research Center of Guilan University of Medical Sciences

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