NCT07412340

Brief 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. 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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Jan 2026Jun 2026

Study Start

First participant enrolled

January 31, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 9, 2026

Last Update Submit

February 17, 2026

Conditions

Nasal Septum Deviation

Keywords

Nasal septum deviationSeptoplastyOpen surgery

Outcome Measures

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.

    Before and at least 3 months after the operation

Secondary Outcomes (4)

  • Compare the functional improvement between the two techniques, using a different tool

    Before and at least 3 months after the operation

  • Compare the improvement in respiratory symptoms between the two techniques

    Before and at least 3 months after the operation

  • Analyze and compare the complication rates between the two techniques

    At day 15 and 3 months after the operation

  • Assess patient satisfaction with aesthetic results (including columellar deviation)

    Before and at least 3 months after the operation

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient undergoing a new disarticulation septoplasty, or an open approach for nasal obstruction due to a deviated nasal septum, confirmed by endoscopy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Novo

Pontoise, France

Location

Related Publications (1)

  • 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).

    BACKGROUND

Study Officials

  • Khaled AL TABAA

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

  • Esthelle MINKA

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathilde WLODARCZYK

CONTACT

0033130754650mathilde.wlodarczyk@ght-novo.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

January 31, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)