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A Comparative Study of Two Endoscopic Operations for Lacrimal Duct Obstruction (ACSOTEOFLDO)

Primary Purpose

Lacrimal Duct Obstruction

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Recessive Spherical Headed Silicone Intubation
Dacryocystorhinostomy
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lacrimal Duct Obstruction focused on measuring Silicone Nasolacrimal Intubation, Dacryocystorhinostomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ThirdSunYatSen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Recessive Spherical Headed Silicone Intubation

Dacryocystorhinostomy

Arm Description

The silicone nasolacrimal intubation under nasal endoscopy can restore natural drainage pathway in tears and as an out-patient surgery, it is more simple,cheap and mini-invasive.Recessive Spherical Headed Silicone Intubation is safe,convenient and almost unpainful for no trauma.It has no facial scar and no damage for structure and function of lacrimal duct.Besides,silica gel is non-toxic and nonirritating.Nasal endoscopy handed by otorhinolaryngologist helps intraoperative visualization about anatomy of the nasal cavity,understanding and management of congenital nasolacrimal duct obstruction and is the only method that confirms the correct anatomic position of the catheterization and in real time,avoiding traditionally the blind raking-out wire by the ophthalmologist alone.Compare to the classic DCR,its short therapeutic effects are equal but more convenient and fewer time and money-cost.

Nasolacrimal 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.After surgery the lacrimal passage can't siphon the tear out physically any more so that it will effect the patients' life.Besides,the operating time,bleeding volume,hospitalization time and total cost for the surgery is higher.

Outcomes

Primary Outcome Measures

Epiphora Improvement
Cure:postoperative epiphora disappeared. Effective:clinical symptom remission. Invalid:no effect on epiphora.
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.

Secondary Outcome Measures

Postoperative Visual Analogue Scale (VAS)
From 0 to 10 according to the patients' feeling and life quality

Full Information

First Posted
December 9, 2015
Last Updated
October 10, 2017
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02636257
Brief Title
A Comparative Study of Two Endoscopic Operations for Lacrimal Duct Obstruction
Acronym
ACSOTEOFLDO
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lacrimal Duct Obstruction
Keywords
Silicone Nasolacrimal Intubation, Dacryocystorhinostomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recessive Spherical Headed Silicone Intubation
Arm Type
Experimental
Arm Description
The silicone nasolacrimal intubation under nasal endoscopy can restore natural drainage pathway in tears and as an out-patient surgery, it is more simple,cheap and mini-invasive.Recessive Spherical Headed Silicone Intubation is safe,convenient and almost unpainful for no trauma.It has no facial scar and no damage for structure and function of lacrimal duct.Besides,silica gel is non-toxic and nonirritating.Nasal endoscopy handed by otorhinolaryngologist helps intraoperative visualization about anatomy of the nasal cavity,understanding and management of congenital nasolacrimal duct obstruction and is the only method that confirms the correct anatomic position of the catheterization and in real time,avoiding traditionally the blind raking-out wire by the ophthalmologist alone.Compare to the classic DCR,its short therapeutic effects are equal but more convenient and fewer time and money-cost.
Arm Title
Dacryocystorhinostomy
Arm Type
Other
Arm Description
Nasolacrimal 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.After surgery the lacrimal passage can't siphon the tear out physically any more so that it will effect the patients' life.Besides,the operating time,bleeding volume,hospitalization time and total cost for the surgery is higher.
Intervention Type
Procedure
Intervention Name(s)
Recessive Spherical Headed Silicone Intubation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Dacryocystorhinostomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Epiphora Improvement
Description
Cure:postoperative epiphora disappeared. Effective:clinical symptom remission. Invalid:no effect on epiphora.
Time Frame
one-year follow-up
Title
Lacrimal Passage Irrigation
Description
Cure:no reflux after lacrimal passage irrigation. Effective:a little reflux after lacrimal passage irrigation. Invalid:a lot reflux after lacrimal passage irrigation.
Time Frame
one-year follow-up
Secondary Outcome Measure Information:
Title
Postoperative Visual Analogue Scale (VAS)
Description
From 0 to 10 according to the patients' feeling and life quality
Time Frame
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 Pre-specified Outcome Measures:
Title
Bleeding volume in milliliter during the surgery
Description
The surgeon records the cadaverine quantity of bleeding
Time Frame
one-year follow-up
Title
Operating time in minutes
Description
Recessive Spherical Headed Silicone Intubation Under Nasal Endoscopy was from dilatation to unobstructed lacrimal irrigation.Dacryocystorhinostomy was from flap incision to packing.
Time Frame
one-year follow-up
Title
hospitalization time in hours
Description
From admission formalities to leave hospital
Time Frame
one-year follow-up
Title
total cost on the treatment in yuan
Description
From admission formalities to leave hospital
Time Frame
one-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Qintai, director
Organizational Affiliation
Sun Yat Sen Univ, Affiliated Hosp 3, Dept Otorhinolaryngol Head & Neck Surg, Guangzhou 510630, Guangdong, Peoples R China.
Official's Role
Study Director
Facility Information:
Facility Name
ThirdSunYatSen
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
2769026
Citation
McDonogh M, Meiring JH. Endoscopic transnasal dacryocystorhinostomy. J Laryngol Otol. 1989 Jun;103(6):585-7. doi: 10.1017/s0022215100109405.
Results Reference
background
PubMed Identifier
11603798
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.
Results Reference
background
PubMed Identifier
11802041
Citation
Wormald PJ. Powered endoscopic dacryocystorhinostomy. Laryngoscope. 2002 Jan;112(1):69-72. doi: 10.1097/00005537-200201000-00013.
Results Reference
background
PubMed Identifier
23120728
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.
Results Reference
background

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A Comparative Study of Two Endoscopic Operations for Lacrimal Duct Obstruction

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