Investingation on Outcomes After Combining Septoplasty With Additional Procedures.

NCT07127848 | Enrolling By Invitation

• 1 other identifier: 2025-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study will be to compare postoperative nasal airflow and symptom improvement using a NOSE form in patients after different types of surgical treatment. Patients will be treated with one of the following operations: septoplasty with turbinectomy, septoplasty with radiofrequent ablation of the nasal turbinates, or septoplasty with valvuloplasty. This is a single-center prospective randomized interventional comparative study on patients in a tertiary rhinology center, who will undergo septoplasty alongside one additional rhinologic procedure aimed at improving nasal patency.

Conditions

Nasal Patency; Breathing Disorder During Sleeping; Breathing Mechanics

Keywords

septoplasty; turbinectomy; Valvuloplasty; mucotomy; breathing outcome; nasal breathing

Outcome Measures

Primary Outcomes (2)

• PNIF

  Peak Nasal Inspiratory Flow measurement - objective measurement of nasal patency in liters per minute.

  Every months until six months postoperatively.

• NOSE questionnaire

  Validated PROM regarding subjective nasal patency assessment.

  Every month up to 6 months post surgery.

Study Arms (3)

Septoplasty with Mucotomy

ACTIVE COMPARATOR

Septoplasty accompanied by radiofrequent mucotomy of the inferior nasal turbinates.

Procedure: Septoplasty with Valvuloplasty

Septoplasty and Turbinectomy

ACTIVE COMPARATOR

Septoplasty accompanied by surgical resection of the inferior nasal turbinates.

Procedure: Septoplasty with Mucotomy

Septoplasty and Valvuloplasty

ACTIVE COMPARATOR

Septoplasty accompanied by placing a flaring sutture in the internal nasal valve area.

Procedure: Septoplasty with Turbinectomy

Interventions

Septoplasty with Mucotomy PROCEDURE

Subtotal reconstruction of the nasal septum accompanied by radiofrequent nasal mucosal reduction of the inferior turbinates.

Septoplasty and Turbinectomy

Septoplasty with Turbinectomy PROCEDURE

Subtotal reconstruction of the nasal septum accompanied by surgical resection of the inferior turbinates.

Septoplasty and Valvuloplasty

Septoplasty with Valvuloplasty PROCEDURE

Subtotal reconstruction of the nasal septum accompanied by surgical intervention by placing a flare sutture in the internal nasal valve area.

Septoplasty with Mucotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were 18 years and above, without any disease or condition affecting nasal breathing apart from allergic rhinitis, septal deviation, hypertrophy of the nasal turbinates.

You may not qualify if:

• Patients with a history of psychological or mental illness, prior nasal surgery or nasal polyposis were excluded from the study. Use of any medication related to airway management or nasal patency, such as decongestants or mucolytics, or nasal dilators to influence the external and internal nasal valve function during the study period was not allowed.

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead

Study Sites (1)

University Hospital Center Sestre milosrdnice

Zagreb, 10000, Croatia

Location

Related Publications (1)

• Hernandez AK, Uhl C, Haehner A, Cuevas M, Hummel T. Objective nasal airflow measures in relation to subjective nasal obstruction, trigeminal function, and olfaction in patients with chronic rhinosinusitis. Rhinology. 2024 Aug 1;62(4):394-402. doi: 10.4193/Rhin23.270.

  PMID: 38507726 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Andro Košec, MD, PhD, FEBORL-HNS, FACS

  University Hospital Center Sestre milosrdnice, Department of ORL&HNS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Otorhinolaryngologist and Head and Neck Surgeon

Model Details: The patients will be randomized into three groups: those undergoing septoplasty with turbinectomy, those undergoing septoplasty with flaring sutures of the internal nasal valve and those undergoing septoplasty with radiofrequent ablation of the inferior nasal turbinates.

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 17, 2025
• Study Start: April 1, 2025
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)