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Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy

NCT ID: NCT05698940

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-29

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Nasal Blockage Nasal Obstruction Septum; Deviation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Infundibulotomy

Infundibulotomy on one side of sinuses

Group Type ACTIVE_COMPARATOR

Infundibultomy

Intervention Type PROCEDURE

Infundibultomy on one side of patient

No Infundibultomty

No Intervention on other side of sinuses

Group Type SHAM_COMPARATOR

Infundibultomy

Intervention Type PROCEDURE

Infundibultomy on one side of patient

Interventions

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Infundibultomy

Infundibultomy on one side of patient

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Unilateral breathing impairment due to septal deviation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zurich University Hospital

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Facility Contacts

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Michael Soyka, Dr.med.

Role: primary

Other Identifiers

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KEK 2015-0356

Identifier Type: -

Identifier Source: org_study_id