A Comparative Study of Two Endoscopic Operations for Lacrimal Duct Obstruction

Lacrimal Duct Obstruction Clinical Trial

— ACSOTEOFLDO  

Official title:

A Comparative Study of Recessive Spherical Headed Silicone Intubation and Dacryocystorhinostomy Under Nasal Endoscopy in the Treatment of Nasolacrimal Duct Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636257
• Other study ID #: SYSU-5010
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 9, 2015
• Last updated: October 10, 2017
• Start date: July 2015
• Est. completion date: January 2017

Study information

• Verified date: October 2017
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the clinical effects between the silicone nasolacrimal intubation under nasoendoscopy and dacryocystorhinostomy on patients with lacrimal duct obstruction.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lacrimal Duct Obstruction

Intervention

Procedure:
• Recessive 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.
• Dacryocystorhinostomy
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.

Locations

Country	Name	City	State
China	ThirdSunYatSen	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (4)

McDonogh M, Meiring JH. Endoscopic transnasal dacryocystorhinostomy. J Laryngol Otol. 1989 Jun;103(6):585-7. — View Citation

Onerci M, Orhan M, Ogretmenoglu O, Irkeç M. Long-term results and reasons for failure of intranasal endoscopic dacryocystorhinostomy. Acta Otolaryngol. 2000 Mar;120(2):319-22. — View Citation

Saroj G, Rashmi G. Conventional dacryocystorhinostomy versus endonasal dacryocystorhinostomy-a comparative study. Indian J Otolaryngol Head Neck Surg. 2010 Sep;62(3):296-8. doi: 10.1007/s12070-010-0087-4. Epub 2010 Oct 12. — View Citation

Wormald PJ. Powered endoscopic dacryocystorhinostomy. Laryngoscope. 2002 Jan;112(1):69-72. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bleeding volume in milliliter during the surgery	The surgeon records the cadaverine quantity of bleeding	one-year follow-up
Other	Operating time in minutes	Recessive Spherical Headed Silicone Intubation Under Nasal Endoscopy was from dilatation to unobstructed lacrimal irrigation.Dacryocystorhinostomy was from flap incision to packing.	one-year follow-up
Other	hospitalization time in hours	From admission formalities to leave hospital	one-year follow-up
Other	total cost on the treatment in yuan	From admission formalities to leave hospital	one-year follow-up
Primary	Epiphora Improvement	Cure:postoperative epiphora disappeared. Effective:clinical symptom remission. Invalid:no effect on epiphora.	one-year follow-up
Primary	Lacrimal Passage Irrigation	Cure:no reflux after lacrimal passage irrigation. Effective:a little reflux after lacrimal passage irrigation. Invalid:a lot reflux after lacrimal passage irrigation.	one-year follow-up
Secondary	Postoperative Visual Analogue Scale (VAS)	From 0 to 10 according to the patients' feeling and life quality	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.