Hopital Novo
Pontoise, France
NCT Number: NCT07412340
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)
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Pontoise, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient undergoing surgery but with the following medical history (on the day of surgery):
Comparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practice
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.
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
Time frame: Before and at least 3 months after the operation
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: At day 15 and 3 months after the operation
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: Before and at least 3 months after the operation
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.
Contact information is provided by the study sponsor or research team.
Hôpital NOVO
Other
Disarticulation Septoplasty Versus Classical Septoplasty: Retrospective Study
Acronym: DSARTICULATION
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.
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