Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy (InfundSPL)

Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy/Uncinectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Nasal Obstruction; Nasal Blockage; Septum; Deviation
• Intervention / Treatment: Procedure: Infundibultomy

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • Zurich University Hospital
    • Contact: Michael Soyka, Dr.med.; Phone Number: +41 44 255 11 11; Email: michael.soyka@usz.ch
    • Principal Investigator: Michael Soyka, Dr.med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Unilateral breathing impairment due to septal deviation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Infundibulotomy; Infundibulotomy on one side of sinuses	Procedure: Infundibultomy; Infundibultomy on one side of patient
Sham Comparator: No Infundibultomty; No Intervention on other side of sinuses	Procedure: Infundibultomy; Infundibultomy on one side of patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single sided VAS Scores for breathing impairment	Rating of nasal breating on a 0-10 scale	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2016
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: KEK 2015-0356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No