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

University of Zurich (UZH)

Status: Enrolling

Conditions: Nasal Obstruction; Nasal Blockage; Septum; Deviation

Treatments: Procedure: Infundibultomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05698940

KEK 2015-0356

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Unilateral breathing impairment due to septal deviation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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35 participants in 2 patient groups

Infundibulotomy

Active Comparator group

Description:

Infundibulotomy on one side of sinuses

Treatment:

Procedure: Infundibultomy

No Infundibultomty

Sham Comparator group

Description:

No Intervention on other side of sinuses

Treatment:

Procedure: Infundibultomy