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EndoDCRevol: Endonasal Dacryocystorhinostomy and Evolution of the Stoma Size

Sponsor
Centre Hospitalier Régional Metz-Thionville (Other)
Overall Status
Completed
CT.gov ID
NCT04054791
Collaborator
(none)
18
Enrollment
42
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    18 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Endonasal Dacryocystorhinostomy: Prospective Study of the Evolution of the Stoma Size
    Actual Study Start Date :
    Jan 1, 2016
    Actual Primary Completion Date :
    Apr 1, 2017
    Actual Study Completion Date :
    Jul 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Evolution of the stoma size [Month 12]

      Measurement of the stoma size by endonasal photography

    Secondary Outcome Measures

    1. Mucous orifices size [Month 2]

      Measurement of the osteotomy orifices size from photography

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient with chronic epiphora or chronic dacryocystitis
    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Centre Hospitalier Régional Metz-Thionville

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Régional Metz-Thionville
    ClinicalTrials.gov Identifier:
    NCT04054791
    Other Study ID Numbers:
    • 2016-10Obs-CHRMT
    First Posted:
    Aug 13, 2019
    Last Update Posted:
    Aug 13, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 13, 2019