Endonasal Dacryocystorhinostomy and Evolution of the Stoma Size

Completed

• Conditions: Endonasal Dacryocystorhinostomy

• Registration Number: NCT04054791
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-04-01
• Study Completion: 2019-07-01
• Status Verified: 2019-08
• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-12
• Last Update Submitted: 2019-08-12
• Study First Posted: 2019-08-13
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Patient with chronic epiphora or chronic dacryocystitis

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evolution of the stoma size	Month 12	Measurement of the stoma size by endonasal photography

Secondary Outcome Measures

Name	Time	Method
Mucous orifices size	Month 2	Measurement of the osteotomy orifices size from photography
Ratio of patients for whom the operation is a success	Month 12	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