- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07412340
Disarticulation Septoplasty Versus Classical Way (DSARTICULATION)
Disarticulation Septoplasty Versus Classical Septoplasty: Retrospective Study
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)
Study Overview
Status
Conditions
Detailed Description
Nowadays, disarticulation septoplasty is recognized as an effective technique for correcting complex septal deviations. It allows better exposure of the nasal septum, which facilitates the correction of severe deformities and reduces post-operative complications. This method is often compared to open surgery, which remains a classic approach but perhaps less suited to cases of severe or complex deviations. This technique makes it possible to correct aesthetic deviations while improving the functional aspect avoiding an open path.
There are several questionnaires, particularly in the field of rhinology, to evaluate the results of this technique on nasal obstruction in an objective and subjective manner, therefore its impact on quality of life as well as its effectiveness on chronic nasal dysfunction caused by deviation of the nasal septum. In this study, in addition to nasal symptoms before and after surgery and postoperative complications, we chose to work with two scores; NOSE score as a valid, reliable and responsive self-report instrument to quantify subjective dysfunction related to nasal obstruction. The other score is NAFEQ score which makes it possible to evaluate the aesthetic and functional outcome after nasal reconstruction.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mathilde WLODARCZYK
- Phone Number: 0033130754650
- Email: mathilde.wlodarczyk@ght-novo.fr
Study Locations
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Pontoise, France
- Hôpital NOVO
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Contact:
- Khaled AL TABAA
- Phone Number: 0033130754040
- Email: khaled.altabaa@ght-novo.fr
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Contact:
- Esthelle MINKA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
Patient undergoing surgery but with the following medical history (on the day of surgery):
- Patient with septal perforations
- Patient with previous nasal septum surgery or cosmetic rhinoplasty
- Patient with allergic rhinitis
- Patient with chronic sinusitis
- Patient with concha bullosa
- Refusal to participate
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To determine which of the two techniques (disarticulation septoplasty versus open surgery) offers the best functional results to correct symptomatic nasal septum deviations
Time Frame: Before and at least 3 months after the operation
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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.
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Before and at least 3 months after the operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compare the functional improvement between the two techniques, using a different tool
Time Frame: Before and at least 3 months after the operation
|
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
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Before and at least 3 months after the operation
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Compare the improvement in respiratory symptoms between the two techniques
Time Frame: Before and at least 3 months after the operation
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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.
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Before and at least 3 months after the operation
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Analyze and compare the complication rates between the two techniques
Time Frame: At day 15 and 3 months after the operation
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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.
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At day 15 and 3 months after the operation
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Assess patient satisfaction with aesthetic results (including columellar deviation)
Time Frame: Before and at least 3 months after the operation
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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.
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Before and at least 3 months after the operation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Khaled AL TABAA, Hôpital NOVO
- Principal Investigator: Esthelle MINKA, Hôpital NOVO
Publications and helpful links
General Publications
- R. Jankowski, P. Gallet, D.-T. Nguyen, C. Rumeau. Septoplasty by disarticulation. European Annals of Otorhinolaryngology, Head and Neck Diseases, 2020, 137 (5), pp.423-426. (10.1016/j.anorl.2020.07.014). (hal03492978).
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHRD 1925
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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