Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorAssiut University
About this trial
This prospective, single-arm interventional clinical study aims to evaluate the short- and intermediate-term anatomical, functional, and quality-of-life outcomes of primary stentless endoscopic dacryocystorhinostomy (En-DCR) in adult patients with primary acquired nasolacrimal duct obstruction (PANDO). Endoscopic DCR bypasses the obstructed distal lacrimal drainage pathway by creating a permanent communication between the lacrimal sac and the nasal cavity. While silicone intubation is traditionally used to prevent early restenosis, its routine use remains controversial due to potential foreign-body morbidity, including canalicular trauma, granuloma formation, tube displacement, and the necessity for a secondary removal procedure. The rationale for this study is based on the concept that surgical success is determined by adequate osteotomy, wide sac marsupialization, mucosal flap preservation, and structured postoperative care, rather than the presence of a permanent foreign body. The study will recruit approximately 40 eligible adults (aged $\\ge$16 years) with objectively confirmed, symptomatic PANDO to undergo a standardized stentless En-DCR procedure. Participants will undergo rigorous postoperative clinical and endoscopic assessments at 1 week, 1 month, 3 months, 6 months, and 12 months. The primary endpoint is the overall composite success rate at 12 months, defined by both objective anatomical patency of the rhinostomy (verified via endoscopy and lacrimal irrigation) and clinically meaningful functional resolution of epiphora (Munk score 0-1). Secondary objectives include quantifying changes in disease-specific quality of life using the Lac-Q questionnaire, documenting postoperative endoscopic healing parameters, and evaluating the incidence and mechanisms of surgical failure or complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Stentless Endoscopic Dacryocystorhinostomy
Procedure/SurgeryThe intervention consists of a primary endoscopic dacryocystorhinostomy (En-DCR) performed without the routine insertion of a silicone bicanalicular or monocanalicular stent. The standardized surgical technique involves endoscopic localization of the lacrimal sac, creation of a mucosal flap, and a wide bony osteotomy to expose the lacrimal bone and frontal process of the maxilla. The lacrimal sac is opened longitudinally and widely marsupialized into the nasal cavity, prioritizing mucosal flap preservation and precise apposition without placing a tube. This technique relies on adequate osteotomy, sac marsupialization, mucosal healing, and structured postoperative endoscopic care rather than a permanent foreign body to maintain a functional rhinostomy.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Stentless Endoscopic Dacryocystorhinostomy (En-DCR)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants Achieving Overall Clinical Success
Overall success is a composite endpoint defined by achieving both functional improvement and anatomical patency. Functional success requires clinically meaningful resolution or marked improvement of epiphora, indicated by achieving a Munk score of 0 or 1. Anatomical success requires objective patency of the surgically created rhinostomy, demonstrated by nasal endoscopy and successful lacrimal irrigation without evidence of clinically significant restenosis. A patient must meet both criteria to be considered an overall success, avoiding overestimation based on anatomy alone.
Time frame
12 months postoperativeSecondary outcomes
1
Number of Participants Achieving Anatomical Success
Anatomical success is defined as a patent rhinostomy on endoscopic examination with free or satisfactory lacrimal irrigation and no clinically significant obstructing granulation, fibrosis, or synechiae.
Time frame
1 week, 1 month, 3 months, 6 months, and 12 months postoperative2
Number of Participants Achieving Functional Success
Functional success is defined by the substantial improvement or resolution of epiphora, indicated by achieving a Munk Epiphora Score of 0 or 1. The Munk Epiphora Score is a grading scale used to quantify tearing severity. The scale ranges from 0 to 4, where 0 indicates no epiphora and 4 indicates constant, severe epiphora requiring wiping 10 or more times a day. Higher scores indicate worse outcomes (more severe tearing).
Time frame
Baseline, 1 month, 3 months, 6 months, and 12 months postoperative3
Mean Lacrimal Symptom Questionnaire (Lac-Q) Score
Assessment of the social impact and disease-specific quality of life using the Lacrimal Symptom Questionnaire (Lac-Q) to evaluate patient-reported outcomes and symptom improvement. The Lac-Q score ranges from 0 to 14 \[(Note: adjust these min/max numbers if your specific modified version of the Lac-Q differs)\], where higher scores indicate a worse outcome (greater negative impact on quality of life and more severe symptoms).
Time frame
Baseline, 3 months, and 12 months postoperativeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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