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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05698940
Other study ID # KEK 2015-0356
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 29, 2016
Est. completion date December 31, 2024

Study information

Verified date November 2023
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Septoplasty is one of the most common procedures in rhinology. In many centers and private institutions, an infundibulotomy is performed in addition to septoplasty without evidence of significant improvement for the patient. Often the reason given for this is the improvement of the functional outcome in terms of better nasal breathing, although there is no evidence for this. If a significantly better outcome can be shown, one would have a first evidence for the extended procedure.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date December 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Unilateral breathing impairment due to septal deviation

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Infundibultomy
Infundibultomy on one side of patient

Locations

Country Name City State
Switzerland Zurich University Hospital Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Single sided VAS Scores for breathing impairment Rating of nasal breating on a 0-10 scale 3 months
Secondary SNOT Score Quality of Life Measure from 0-110 3 months
Secondary NOSE Score Nasal symptom questionnaire 3 months
Secondary PNIF Peak Nasal Inspiratory Flow measured in ml/sec 3 months
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