NCT Number: NCT04054791
Endonasal Dacryocystorhinostomy and 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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patient with chronic epiphora or chronic dacryocystitis
Exclusion criteria
-
Treatment and study plan
Primary outcomes
-
Evolution of the stoma size
Time frame: Month 12
Measurement of the stoma size by endonasal photography
Secondary outcomes
-
Mucous orifices size
Time frame: Month 2
Measurement of the osteotomy orifices size from photography
-
Ratio of patients for whom the operation is a success
Time frame: 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
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Régional Metz-Thionville
Other
Registry information
Official study title
Endonasal Dacryocystorhinostomy: Prospective Study of the Evolution of the Stoma Size
Acronym: EndoDCRevol
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2019
- First posted
- Aug 13, 2019
- Registry last updated
- Aug 13, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.