Disarticulation Septoplasty Versus Classical Way
ConditionNasal Septum Deviation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHôpital NOVO
About this trial
The objective of this study is to determine which of the two techniques (disarticulation septoplasty versus open surgery) offers the best functional results for correcting symptomatic deviations of the nasal septum.
More specifically it's about:
* Compare the improvement in respiratory symptoms between the two techniques * Analyze and compare complication rates between the two techniques * Evaluate patient satisfaction with aesthetic results (including columella deviation)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 18 and over
Patient undergoing a new disarticulation septoplasty, or an open approach for nasal obstruction due to a deviated nasal septum, confirmed by endoscopy
Patient operated between 01/01/2023 and 31/12/2025
Disqualifiers
Patient with septal perforations
Patient with previous nasal septum surgery or cosmetic rhinoplasty
Patient with allergic rhinitis
Patient with chronic sinusitis
Trial population
Patient undergoing a new disarticulation septoplasty, or an open approach for nasal obstruction due to a deviated nasal septum, confirmed by endoscopy
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Comparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practice
Other interventionComparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practice
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
To determine which of the two techniques (disarticulation septoplasty versus open surgery) offers the best functional results to correct symptomatic nasal septum deviations
Comparison of functional improvement in nasal breathing between the two techniques (disarticulation septoplasty versus classic septoplasty), using the standardized NOSE score routinely completed by patients pre-operatively and then 3 months post-operation.
Time frame
Before and at least 3 months after the operationSecondary outcomes
1
Compare the functional improvement between the two techniques, using a different tool
The functional improvement in nasal breathing between the two techniques will also be assessed using the NAFEQ score, which is also routinely completed pre-operatively and then 3 months after the operation
Time frame
Before and at least 3 months after the operation2
Compare the improvement in respiratory symptoms between the two techniques
The improvement in patients' symptoms will be compared between the two techniques using the responses to the NOSE questionnaire and responses 1-6 of the NAFEQ questionnaire.
Time frame
Before and at least 3 months after the operation3
Analyze and compare the complication rates between the two techniques
The number of the following complications will be compared between the two techniques: bleeding up to day 15, infections up to day 15, and septal perforations up to M3. These data will be available in the patient's medical record.
Time frame
At day 15 and 3 months after the operation4
Assess patient satisfaction with aesthetic results (including columellar deviation)
Patient satisfaction with aesthetics will be measured using questions 8 to 14 of the NAFEQ questionnaire and then compared between the two techniques preoperatively and 3 months postoperatively.
Time frame
Before and at least 3 months after the operationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: