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Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction.
Sponsor: Assiut University
Summary
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.
Official title: Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2027-01-01
Completion Date
2028-06-01
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
Stentless Endoscopic Dacryocystorhinostomy
The 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.