Clinical trial NCT02636257: A Comparative Study of Two Endoscopic Operations for Lacrimal Duct Obstruction
Official title: A Comparative Study of Recessive Spherical Headed Silicone Intubation and Dacryocystorhinostomy Under Nasal Endoscopy in the Treatment of Nasolacrimal Duct Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lacrimal Duct Obstruction
Keywords: Silicone Nasolacrimal Intubation
Dacryocystorhinostomy
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Epiphora Improvement
timeFrame: one-year follow-up
measure: Lacrimal Passage Irrigation
timeFrame: one-year follow-up
Secondary outcomes:
measure: Postoperative Visual Analogue Scale (VAS)
timeFrame: 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.
Other outcomes:
measure: Bleeding volume in milliliter during the surgery
timeFrame: one-year follow-up
measure: Operating time in minutes
timeFrame: one-year follow-up
measure: hospitalization time in hours
timeFrame: one-year follow-up
measure: total cost on the treatment in yuan
timeFrame: one-year follow-up
Locations:
city: Guangzhou
country: China
facility: ThirdSunYatSen
state: Guangdong
Study officials:
affiliation: Sun Yat Sen Univ, Affiliated Hosp 3, Dept Otorhinolaryngol Head & Neck Surg, Guangzhou 510630, Guangdong, Peoples R China.
name: Yang Qintai, director
role: STUDY_DIRECTOR
References:
citation: McDonogh M, Meiring JH. Endoscopic transnasal dacryocystorhinostomy. J Laryngol Otol. 1989 Jun;103(6):585-7. doi: 10.1017/s0022215100109405.
citation: Onerci M, Orhan M, Ogretmenoglu O, Irkec M. Long-term results and reasons for failure of intranasal endoscopic dacryocystorhinostomy. Acta Otolaryngol. 2000 Mar;120(2):319-22. doi: 10.1080/000164800750001170.
citation: Wormald PJ. Powered endoscopic dacryocystorhinostomy. Laryngoscope. 2002 Jan;112(1):69-72. doi: 10.1097/00005537-200201000-00013.
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.