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Risk and Importance of Peroperative Nasal Hemorrhage in the Treatment of Lacrimal Duct Obstruction in Young Children

NCT ID: NCT02851641

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-02

Study Completion Date

2019-12-10

Brief Summary

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The aim of the study is to evaluate the risk in intra-operative nasal hemorrhage when using a "pushed" probe (Master Ka) in the treatment of naso lacrimal duct obstruction (NLDO).

In the investigator's experience, this risk seemed to minus using a pushed probe rather than the classical pulled-type probes.

A lower risk of hemorrhage could lead to a change in the anesthetic procedure. The gold standard in NLDO is the use of an orotracheal intubation. It could then be replaced by the use of an orolaryngeal mask. A forthcoming study will evaluate the results of this anesthetic change.

Detailed Description

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Conditions

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Lacrimal Duct Obstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nasolacrimal duct obstruction

"pushed" mono-canaliculonasal intubation

Intervention Type PROCEDURE

Interventions

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"pushed" mono-canaliculonasal intubation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* \< 6 years of age
* Unilateral lacrimal duct obstruction with programmed surgery
* Surgery scheduled wih a "pushed" mono-canaliculonasal intubation
* No opposition of parents for he participation of their child

Exclusion Criteria

* Coagulation disorder
* Previous history of nasolacrimal intubation (homo or contra-lateral)
* Non covered by health insurance
Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation Ophtalmologique A. de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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CEN_2015_9

Identifier Type: -

Identifier Source: org_study_id