Nasal Septum DeviationDSARTICULATIONNCT07412340
Disarticulation Septoplasty Versus Classical Way
An observational study of Nasal Septum Deviation, run by Hôpital NOVO at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Septum Deviation
- What is being tested?
- Comparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practice
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2026to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient undergoing a new disarticulation septoplasty, or an open approach for nasal obstruction due to a deviated nasal septum, confirmed by endoscopy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hopital Novo
Pontoise
Khaled AL TABAA, 0033130754040, khaled.altabaa@ght-novo.fr
Esthelle MINKA
About this study
Official title: 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)
Read the 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.
- Conditions
- Nasal Septum Deviation
- Being tested
- Comparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practice
- Keywords
- Nasal septum deviation, Septoplasty, Open surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practiceOther
Comparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practice
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and at least 3 months after the operation
Secondary outcomes (4)
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
Measured: Before and at least 3 months after the operation
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.
Measured: Before and at least 3 months after the operation
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.
Measured: At day 15 and 3 months after the operation
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.
Measured: Before and at least 3 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start31 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal Septum DeviationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khaled AL TABAA, Principal investigator, Hôpital NOVOEsthelle MINKA, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412340
- Sponsor's protocol ID
- CHRD 1925
- Acronym
- DSARTICULATION
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jankowski R, Gallet P, Nguyen DT, Rumeau C. Septoplasty by disarticulation. Eur Ann Otorhinolaryngol Head Neck Dis. 2020 Nov;137(5):423-426. doi: 10.1016/j.anorl.2020.07.014. Epub 2020 Oct 2.
PubMed 33020044
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disarticulation Septoplasty Versus Classical Septoplasty: Retrospective Study
- ClinicalTrials.gov ID
- NCT07412340
- Acronym / sponsor ID
- DSARTICULATION / CHRD 1925
- Conditions
- Nasal Septum Deviation
- Keywords
- Nasal septum deviation, Septoplasty, Open surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing a new disarticulation septoplasty, or an open approach for nasal obstruction due to a deviated nasal septum, confirmed by endoscopy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practiceComparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practice | Other | – |
Primary outcome
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
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.
4 secondary outcomes
Compare the functional improvement between the two techniques, using a different tool
Time frame: Before and at least 3 months after the operation
Compare the improvement in respiratory symptoms between the two techniques
Time frame: Before and at least 3 months after the operation
Analyze and compare the complication rates between the two techniques
Time frame: At day 15 and 3 months after the operation
Assess patient satisfaction with aesthetic results (including columellar deviation)
Time frame: Before and at least 3 months after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Background: PubMed 33020044Jankowski R, Gallet P, Nguyen DT, Rumeau C. Septoplasty by disarticulation. Eur Ann Otorhinolaryngol Head Neck Dis. 2020 Nov;137(5):423-426. doi: 10.1016/j.anorl.2020.07.014. Epub 2020 Oct 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khaled AL TABAA principal investigator
Hôpital NOVO
Esthelle MINKA principal investigator
Hôpital NOVO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Septum Deviation, run by Hôpital NOVO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde WLODARCZYK (0033130754650, mathilde.wlodarczyk@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07412340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.