Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy

Not Applicable

Recruiting

• Conditions: Nasal Obstruction; Nasal Blockage; Septum; Deviation
• Interventions: Procedure: Infundibultomy

• Registration Number: NCT05698940
• Lead Sponsor: University of Zurich

Brief Summary

Septoplasty is one of the most common procedures in rhinology. In many centers and private institutions, an infundibulotomy is performed in addition to septoplasty without evidence of significant improvement for the patient. Often the reason given for this is the improvement of the functional outcome in terms of better nasal breathing, although there is no evidence for this. If a significantly better outcome can be shown, one would have a first evidence for the extended procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-29
• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01
• Primary Completion: 2024-07-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Unilateral breathing impairment due to septal deviation

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No Infundibultomty	Infundibultomy	No Intervention on other side of sinuses
Infundibulotomy	Infundibultomy	Infundibulotomy on one side of sinuses

Primary Outcome Measures

Name	Time	Method
Single sided VAS Scores for breathing impairment	3 months	Rating of nasal breating on a 0-10 scale

Secondary Outcome Measures

Name	Time	Method
PNIF	3 months	Peak Nasal Inspiratory Flow measured in ml/sec
SNOT Score	3 months	Quality of Life Measure from 0-110
NOSE Score	3 months	Nasal symptom questionnaire

Trial Locations

Locations (1)

Zurich University Hospital; 🇨🇭 Zurich, Switzerland