Quality of Life Study About the Role of Turbinectomy in Rhinoseptoplasty

NCT ID: NCT02231216

Last Updated: 2019-01-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Research Question: Performing partial turbinectomy associated with rhinoseptoplasty is responsible for an increase in quality of life related to nasal obstruction when compared to no intervention in rhinoseptoplasty inferior turbinate?

* Population: patients eligible for functional rhinoseptoplasty and / or aesthetic
* Intervention: surgery, turbinectomy of inferior turbinates
* Comparison: the absence of intervention in inferior turbinates
* Primary endpoint: Quality of life related to nasal obstruction

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Deviated Nasal Septum Nasal Septal Defect Nasal Septum, Irregular

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rhinoseptoplasty and turbinectomy

Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.

Group Type EXPERIMENTAL

Rhinoseptoplasty

Intervention Type PROCEDURE

Rhinoseptoplasty without turbinectomy procedure

Partial turbinectomy

Intervention Type PROCEDURE

After medial dislocation of the inferior turbinate, proceed partial resection of the inferior turbinate in all its inferior extension in range. Possible bleeding is cauterized.

Endoscopic partial turbinectomy

Intervention Type PROCEDURE

Endoscopy to medial dislocation of the inferior turbinate with instrument

Rhinoseptoplasty

Patients submitted only to rhinoseptoplasty, without turbinectomy procedure.

Group Type ACTIVE_COMPARATOR

Rhinoseptoplasty

Intervention Type PROCEDURE

Rhinoseptoplasty without turbinectomy procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rhinoseptoplasty

Rhinoseptoplasty without turbinectomy procedure

Intervention Type PROCEDURE

Partial turbinectomy

After medial dislocation of the inferior turbinate, proceed partial resection of the inferior turbinate in all its inferior extension in range. Possible bleeding is cauterized.

Intervention Type PROCEDURE

Endoscopic partial turbinectomy

Endoscopy to medial dislocation of the inferior turbinate with instrument

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Turbinectomy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Eligible patients to rhinoseptoplasty
* Patients who agreed to participate

Exclusion Criteria

* Presence of symptoms of nasal obstruction in the absence of septal deviation, poor support of the nasal tip or clamping of the nasal valve;
* Presence of hypertrophic and obstructive inferior turbinates;
* Presence of sinonasal tumors;
* Patients undergoing treatment of other concomitant rhinoplasty entities such as inflammatory sinus pathology, adenoid hypertrophy, septal perforation, otoplasty and blepharoplasty.
Minimum Eligible Age

6 Months

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bianca H Moura, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Michelle Lavinsky, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

Garcia JPT, Moura BH, Rodrigues VH, Vivan MA, Azevedo SM, Dolci JEL, Migliavacca R, Lavinsky-Wolff M. Inferior Turbinate Reduction during Rhinoplasty: Is There Any Effect on Rhinitis Symptoms? Int Arch Otorhinolaryngol. 2021 Aug 5;26(1):e111-e118. doi: 10.1055/s-0041-1726046. eCollection 2022 Jan.

Reference Type DERIVED
PMID: 35096167 (View on PubMed)

de Moura BH, Migliavacca RO, Lima RK, Dolci JEL, Becker M, Feijo C, Brauwers E, Lavinsky-Wolff M. Partial inferior turbinectomy in rhinoseptoplasty has no effect in quality-of-life outcomes: A randomized clinical trial. Laryngoscope. 2018 Jan;128(1):57-63. doi: 10.1002/lary.26831. Epub 2017 Aug 16.

Reference Type DERIVED
PMID: 28815717 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

130516

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Head and Neck Quality of Life
NCT06756763 COMPLETED