Lacrimal Duct Obstruction
Conditions
Keywords
Silicone Nasolacrimal Intubation, Dacryocystorhinostomy
Brief summary
To compare the clinical effects between the silicone nasolacrimal intubation under nasoendoscopy and dacryocystorhinostomy on patients with lacrimal duct obstruction.
Detailed description
Lacrimal duct obstruction is common among patients with epiphora,which is seriously affect the quality of life. The treatment principle is to restore or rebuild the lacrimal duct drainage channel. The classic operation type is dacryocystorhinostomy(DCR), which is complex for face-section particularly. However, with the development of endoscopy, the investigators prefer to the silicone nasolacrimal intubation under nasal endoscopy, which is more simple and efficient. With endoscopy, the investigators can see anatomical structures clearly and then can perform the operation much more perfectly.Compare to the classic one called DCR, its short and long term therapeutic effects are equal and even better.Therefore,the latter type does do good to both doctors and patients.
Interventions
PROCEDURERecessive Spherical Headed Silicone Intubation
Local anesthesia,regular disinfection, spread sterile towels, exposure operative side.2%lidocaine infiltration anesthesia to inferior orbital nerves, lacrimal punctum and lacrimal sac. Nasal cavity was packed with gauze soaked in 2%ephedrine with 1%tetracaine 15 minutes before procedure.A routine silicone tube of spherical intubation was performed. Dilatated lacrimal point to the end, then inserted the probe with line from lacrimal punctum to inferior meatus through nasolacrimal duct.Cut the line and flush the lacrimal duct physiological saline in 5 mL, flowing the line into the inferior meatus, then suctioned out the line with nasal endoscopy and extracted the probe and dilatated the lacrimal duct again. Insert the spherical silicone tube from lacrimal point to the lacrimal sac, reversing to vertical direction to ensure the tube is inserted into the nasolacrimal duct, then catch the above line but cut short the follow one and fix.Unobstructed lacrimal irrigation.
PROCEDUREDacryocystorhinostomy
Surgery was performed under local anesthesia.Incision was taken over anterior lacrimal crest.Medial palpebral ligament was identified.Orbicularis was separated.Reflection of periosteum and dissection of lacrimal sac from lacrimal fossa was done.Sac was excised to make'H'shaped anterior and posterior flaps. Bony osteum of sufficient size was made with bone punch.Nasal mucosa was cut to make anterior and posterior flaps.Subsequently anterior to anterior and posterior to posterior flaps were sutured.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Nasolacrimal Duct Obstruction based on a clinical of epiphora and purulent secretion, another punctiform orifices with reflux in subsequent flushing in lacrimal passage irrigation; * Must be able to withstand surgery * At least 18 years old * NO lacrimal tumor and acute inflammation * Nasolacrimal duct obstruction in digital subtraction dacryocystography * A sufficient level of education to understand study procedures and be able to communicate with site personnel and adhere to the follow-up; * Accepted informed consent verbally and in writing
Exclusion criteria
* The Poor Health * Be allergic to anesthetics * Lacrimal duct abnormalities * Lacrimal tumor and acute inflammation * Children * The same Surgery failure before Exit Criteria * Postoperative infection and persistent inflammation * Operation failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epiphora Improvement | one-year follow-up | Cure:postoperative epiphora disappeared. Effective:clinical symptom remission. Invalid:no effect on epiphora. |
| Lacrimal Passage Irrigation | one-year follow-up | Cure:no reflux after lacrimal passage irrigation. Effective:a little reflux after lacrimal passage irrigation. Invalid:a lot reflux after lacrimal passage irrigation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Visual Analogue Scale (VAS) | Six times in one-year follow-up,respectively,immediate post-surgical,the 1th week,the 1th month,the 3rd month,the 6th month and the 12th month after the surgery. | From 0 to 10 according to the patients' feeling and life quality |
Other
| Measure | Time frame | Description |
|---|---|---|
| total cost on the treatment in yuan | one-year follow-up | From admission formalities to leave hospital |
| Operating time in minutes | one-year follow-up | Recessive Spherical Headed Silicone Intubation Under Nasal Endoscopy was from dilatation to unobstructed lacrimal irrigation.Dacryocystorhinostomy was from flap incision to packing. |
| hospitalization time in hours | one-year follow-up | From admission formalities to leave hospital |
| Bleeding volume in milliliter during the surgery | one-year follow-up | The surgeon records the cadaverine quantity of bleeding |
Countries
China
Outcome results
None listed