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

Lacrimal Duct Obstruction Clinical Trial

— CANALHEMO  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851641
• Other study ID #: CEN_2015_9
• Status: Completed
• Start date: September 2, 2015
• Est. completion date: December 10, 2019

Study information

• Verified date: December 2019
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 10, 2019
• Est. primary completion date: September 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Lacrimal Duct Obstruction

Intervention

Procedure:
• "pushed" mono-canaliculonasal intubation

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal hemorrhage		Through surgery completion, an average of 1 hour