Risk and Importance of Peroperative Nasal Hemorrhage in t... | NCT02851641

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

NCT02851641

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Dec 11, 2019Actual

Enrollment

108Actual

Phase

Not provided

Conditions

Lacrimal Duct Obstruction

Interventions

"pushed" mono-canaliculonasal intubation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2015Actual

Primary Completion Date

Sep 11, 2019Actual

Completion Date

Dec 10, 2019Actual

First Submitted Date

Jul 28, 2016

First Submission Date that Met QC Criteria

Jul 28, 2016

First Posted Date

Aug 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2019

Last Update Posted Date

Dec 11, 2019Actual

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nasolacrimal duct obstruction			Procedure: "pushed" mono-canaliculonasal intubation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
"pushed" mono-canaliculonasal intubation	Procedure		Nasolacrimal duct obstruction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nasal hemorrhage		Through surgery completion, an average of 1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Years

Standard Ages

Child

Study Population

Children with congenital nasolacrimal duct obstruction

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Ophtalmologique A. de Rothschild		Paris		75019	France

Condition Browse Module

MeSH Terms

ID	Term
D007767	Lacrimal Duct Obstruction

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided