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Comparative Study Between Wide and Narrow Fenstrum Endoscopic DCR

Primary Purpose

Epiphora, Dacryocystitis, Dacryocystocele

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endoscopic dacryocystorhinostomy
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epiphora focused on measuring Endoscopic DCR

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. All patients presented with epiphora due to nasolacrimal duct obstruction with patent canaliculi.
  2. failed conservative treatment in the form of systemic antibiotics, steroid/antibiotic eye drops, decongestant nasal drops and local nasal steroid spray.
  3. fit for surgery under general anesthesia.

Exclusion Criteria:

1- Epiphora due to pre-saccal obstruction of lacrimal drainage system.

2. Eye disease causing increased lacrimation and eyelid malposition

3. Lacrimal fistula.

4. Tumors of the lacrimal passage, nose or paranasal sinus.

5. Patients with abnormal bleeding or coagulation time.

Sites / Locations

  • Ahmed ragab

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Wide fenstrum Endoscopic DCR

Narrow Fenstrum Endoscopic DCR

Arm Description

Outcomes

Primary Outcome Measures

Endoscopic assessment
Measurement dimensions of the DCR ostium by measuring length and width in mile meters by using nasal endoscope
Objective assessment
Objective assessment by flourscine disappearance test

Secondary Outcome Measures

Full Information

First Posted
April 1, 2021
Last Updated
April 2, 2021
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT04833452
Brief Title
Comparative Study Between Wide and Narrow Fenstrum Endoscopic DCR
Official Title
Comparative Study Between Wide and Narrow Fenstrum Endoscopic DCR
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
August 18, 2021 (Anticipated)
Study Completion Date
October 18, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of the study is to compare the efficacy and effectiveness of Endoscopic Endonasal DCR with narrow fenstrum approach and Endoscopic Endonasal DCR with wide fenstrum approach .
Detailed Description
The lacrimal sac and the nasolacrimal duct are contiguous structures . The part of the sac superior to the medial canthal tendon (MCT) is called the fundus, with its vertical length being 3-5 mm . The body of the sac, inferior to the MCT, is about 10 mm in length. The lacrimal sac fossa comprises of the anterior frontal process of the maxillary bone and the posterior lacrimal bone . Lacrimal clearance relies on several factors, such as gravity, capillary attraction forces, evaporation, absorption by the conjunctival surface and the lacrimal "pump" which relies on the action of the orbicularis oculi muscle, particularly its deeper part (Horner's muscle). During the eye closing, the Horner's muscle contracts and the temporal four-fifths part of the canaliculus is pressed and closed, the nasal one-fifth part is pulled posteriorly and opens with shortening of the canalicular length. Therefore, the lacrimal fluid is effectively transported from temporal to nasal sides, finally reaching the lacrimal sac cavity. During the eye opening, as the Horner's muscle relaxes, the temporal four-fifths part of the canaliculus is expanded and the nasal one-fifth part is pressed and closed. The upper part of the lacrimal sac is directly affected by the Horner's muscle movement. During eye closing the sac expands temporally, during the eye opening the sac shrinks with an additional help of its elasticity. The clinical evaluation of the lacrimal drainage system was originally outlined by Lester Jones. Evaluation was in the form of a dye disappearance test followed by a Jones I and Jones II test. The dye disappearance test (DDT) is useful for assessing the presence or absence of adequate lacrimal outflow, especially in unilateral cases. Using a drop of sterile 2% fluorescein solution or a moistened fluorescein strip, the examiner instills fluorescein into the conjunctival fornices of each eye and then observes the tear film. Endoscopic DCR is a widely accepted treatment option for epiphora and dacryocystitis. endoscopic DCR has been widely performed as it has several advantages over external DCR including the absence of face scarring and better visualization via endoscopy. The purpose of DCR is to create a bypass, a rhinostoma, between the lacrimal sac and the nasal cavity. Obstruction site in the lacrimal system is one of the characteristics contributing to a poor prognosis. False localization of the lacrimal sac and inadequate removal of the medial wall of the sac are the most common causes of failure . A systematic review showed that there was a trend towards improved outcomes and reduced granulation without increased complication rates in groups where nasal mucosal and lacrimal flaps were preserved. A study reviewing 100 failed DCR patients showed that inadequate osteotomy, incomplete sac marsupialization, and cicatricial closure of the ostium were the most common causes of failure. To avoid or prevent obstruction of the neo-ostium, many modified techniques have been attempted. These include complete separation of the sac from the nasolacrimal duct to divert lacrimal flow to the neo-ostium, use of steroids or mitomycin-C , silicon tubing and use of mucosal flaps after wide resection of bone surrounding the sac . Initially, endoscopic DCR relied on the creation of a relatively small fenstrum into the lacrimal sac, with the surgeon opening only the lower half of the sac. Many authors claim that the axilla of the middle turbinate is a landmark for the roof of the lacrimal sac. However, Wormald and co-authors, in a study with 47 CT-DCG patients, showed that the major part of the lacrimal sac (10 mm) is situated above the axilla of the middle turbinate, extending 1-2 mm below this landmark. Obtaining a large marsupialized lacrimal sac with wide removal of the covering bone, medial wall of the sac and use of mucosal flaps yields a good surgical result that is comparable to the results of conventional endoscopic DCR techniques with two advantages first, primary surgical failures are amenable to technically simple and highly successful surgical revisions, second, there is a possibility for obtaining wide fenstrum without silicone tube stenting. Success after lacrimal surgery is ill defined, and this has led to confusion in the interpretation of results for various surgical methods. The most practical measure of success is the control of symptoms, although this can be at odds with anatomic outcome. Subjective success in turn can be assessed from the patients' symptoms. Complete relief or significant improvement of complaints can be considered a subjective success. Anatomical patency can readily be judged in objective tests: functional endoscopic dye test or inspection of the ostium, irrigation or fluorescein retention test. Functional NLDO was first described by Demorest and Miller in 1955 to encompass lacrimal drainage dysfunction in the presence of anatomical patency. In those cases, there is a need to exclude other conditions causing epiphora, such as hyper-secretion, lacrimal pump failure, discontinuous drainage apparatus and partial lacrimal duct obstruction. The anatomical success rate i.e. the patency is reported to be higher than the functional success, which highlights the importance of measuring the physiological success and there relief of the patient's symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiphora, Dacryocystitis, Dacryocystocele
Keywords
Endoscopic DCR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wide fenstrum Endoscopic DCR
Arm Type
Active Comparator
Arm Title
Narrow Fenstrum Endoscopic DCR
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Endoscopic dacryocystorhinostomy
Intervention Description
Endoscopic DCR
Primary Outcome Measure Information:
Title
Endoscopic assessment
Description
Measurement dimensions of the DCR ostium by measuring length and width in mile meters by using nasal endoscope
Time Frame
1 year postoperative
Title
Objective assessment
Description
Objective assessment by flourscine disappearance test
Time Frame
1 year postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients presented with epiphora due to nasolacrimal duct obstruction with patent canaliculi. failed conservative treatment in the form of systemic antibiotics, steroid/antibiotic eye drops, decongestant nasal drops and local nasal steroid spray. fit for surgery under general anesthesia. Exclusion Criteria: 1- Epiphora due to pre-saccal obstruction of lacrimal drainage system. 2. Eye disease causing increased lacrimation and eyelid malposition 3. Lacrimal fistula. 4. Tumors of the lacrimal passage, nose or paranasal sinus. 5. Patients with abnormal bleeding or coagulation time.
Facility Information:
Facility Name
Ahmed ragab
City
Cairo
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
33388192
Citation
Bertaux PJ, Gan G, Hirtz G, Mouret P, El-Hachem F, Lhuillier L, Perone JM. Evaluation of ostium size following endoscopic dacryocystorhinostomy as a predictive factor of outcome: A prospective study. J Fr Ophtalmol. 2021 Mar;44(3):397-403. doi: 10.1016/j.jfo.2020.05.024. Epub 2020 Dec 30.
Results Reference
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PubMed Identifier
25525327
Citation
Ali MJ, Psaltis AJ, Wormald PJ. Dacryocystorhinostomy ostium: parameters to evaluate and DCR ostium scoring. Clin Ophthalmol. 2014 Dec 9;8:2491-9. doi: 10.2147/OPTH.S73998. eCollection 2014.
Results Reference
background
PubMed Identifier
16826055
Citation
Mann BS, Wormald PJ. Endoscopic assessment of the dacryocystorhinostomy ostium after endoscopic surgery. Laryngoscope. 2006 Jul;116(7):1172-4. doi: 10.1097/01.mlg.0000218099.33523.19.
Results Reference
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Comparative Study Between Wide and Narrow Fenstrum Endoscopic DCR

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