Endonasal Dacryocystorhinostomy and Evolution of the Stoma Size (EndoDCRevol)

Endonasal Dacryocystorhinostomy: Prospective Study of the Evolution of the Stoma Size

Dacryocystorhinostomy (DCR) is a procedure of choice for nasolacrimal duct obstruction. Endonasal procedures for DCR were described as early as 1893 by Caldwell. However, external DCR was practiced more commonly because of better visualization of anatomic features. The miniaturization of surgical instruments and close partnership between ophthalmologist and otorhinolaryngologist had led to a renewal of endonasal approach.

The main objective of the study is to show the evolution of stoma size after endonasal DCR and validate the direct measurement of mucous orifice. It will also allow determining if the stoma evolution size may be a predictive factor for operational effectiveness.

Study Overview

• Status: Completed
• Conditions: Endonasal Dacryocystorhinostomy

• Study Type: Observational
• Enrollment (Actual): 18

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who had chronic epiphora or chronic dacryocystitis.

Description

Inclusion Criteria:

• Patient with chronic epiphora or chronic dacryocystitis

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the stoma size	Measurement of the stoma size by endonasal photography	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mucous orifices size	Measurement of the osteotomy orifices size from photography	Month 2
Ratio of patients for whom the operation is a success	A success corresponds to the complete disappearance of epiphora symptomatology, on the contrary, a failure equals to the persistence of tearing or a recurrence of dacryocystitis	Month 12

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2016-10Obs-CHRMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No