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OpenTrials
Completed

NCT Number: NCT02851641

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

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.

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Key information

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"pushed" mono-canaliculonasal intubation

Procedure

Primary outcomes

  1. Nasal hemorrhage

    Time frame: Through surgery completion, an average of 1 hour

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: CANALHEMO

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2016
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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