Back to results

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

Primary Purpose

Nasal Blockage, Nasal Obstruction, Septum; Deviation

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Infundibultomy

About this trial

This is an interventional treatment trial for Nasal Blockage

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Unilateral breathing impairment due to septal deviation

Sites / Locations

Zurich University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Infundibulotomy

No Infundibultomty

Arm Description

Infundibulotomy on one side of sinuses

No Intervention on other side of sinuses

Outcomes

Primary Outcome Measures

Single sided VAS Scores for breathing impairment

Rating of nasal breating on a 0-10 scale

Secondary Outcome Measures

SNOT Score

Quality of Life Measure from 0-110

NOSE Score

Nasal symptom questionnaire

PNIF

Peak Nasal Inspiratory Flow measured in ml/sec

Full Information

NCT ID

NCT05698940

First Posted

December 27, 2022

Last Updated

January 25, 2023

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT05698940

Brief Title

Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy

Acronym

InfundSPL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 29, 2016 (Actual)

Primary Completion Date

July 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasal Blockage, Nasal Obstruction, Septum; Deviation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Infundibulotomy

Arm Type

Active Comparator

Arm Description

Infundibulotomy on one side of sinuses

Arm Title

No Infundibultomty

Arm Type

Sham Comparator

Arm Description

No Intervention on other side of sinuses

Intervention Type

Procedure

Intervention Name(s)

Infundibultomy

Intervention Description

Infundibultomy on one side of patient

Primary Outcome Measure Information:

Title

Single sided VAS Scores for breathing impairment

Description

Rating of nasal breating on a 0-10 scale

Time Frame

3 months

Secondary Outcome Measure Information:

Title

SNOT Score

Description

Quality of Life Measure from 0-110

Time Frame

3 months

Title

NOSE Score

Description

Nasal symptom questionnaire

Time Frame

3 months

Title

PNIF

Description

Peak Nasal Inspiratory Flow measured in ml/sec

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Unilateral breathing impairment due to septal deviation

Facility Information:

Facility Name

Zurich University Hospital

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Soyka, Dr.med.

Phone

+41 44 255 11 11

michael.soyka@usz.ch

First Name & Middle Initial & Last Name & Degree

Michael Soyka, Dr.med.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy

We'll reach out to this number within 24 hrs