The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment
1 other identifier
interventional
50
1 country
1
Brief Summary
Nasal obstruction is one of the majors concerns in reduction rhinoseptoplasty, because it affects quality of life and surgical outcomes. Is the association of middle third grafts with reduction rhinoseptoplasty responsible for an increase in quality of life related to nasal obstruction when compared to reduction rhinoseptoplasty without the placement of these grafts?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 3, 2018
CompletedFirst Submitted
Initial submission to the registry
July 21, 2020
CompletedFirst Posted
Study publicly available on registry
August 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedAugust 5, 2020
July 1, 2020
2.4 years
July 21, 2020
July 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Nasal Obstruction Symptom Evaluation Scale (NOSE)
The NOSE will be used to measure the quality of life related to nasal obstruction. It is a validated instrument specifically designed for use in patients with nasal obstruction. According to this scale patients are asked to evaluate difficulty breathing in a general way and specifically the difficulty in breathing through the nose, breathing during sleep, and severity of their nasal congestion. The severity of the symptoms is recorded on a scale of 0 to 4, with 0 being the absence of a problem and 4 being a serious problem. The possible scores range from 0 to 20 and the higher scores indicate a higher degree of nasal obstruction. The sum of the scores is multiplied by 5 so as to obtain a final score ranging from 0 to 100, with higher values associated with poorer quality of life. The scale will be applied at the base line and at 30, 90 and 180 postoperative days.
180 postoperative days
Secondary Outcomes (5)
Rhinoplasty Outcome Evaluation (ROE) Scale
180 postoperative days
Visual Analogue Scale - Nasal Obstruction
180 postoperative days
Clinical Diagnosis of Allergic Rhinitis
Base line and 180 postoperative days
Complications
7 until 180 postoperative days
Anterior Rhinoscopy and Nasal Endoscopy
Base line and 180 postoperative days
Study Arms (2)
Spreader Graft
EXPERIMENTALPlacement and attachment with 5.0 polydioxanone (PDS) suture 2 grafts in the middle third of the nose
Without Spreader Graft
NO INTERVENTIONNo engraftment in the middle third
Interventions
To place and attach with 5.0 PDS suture 2 grafts in the middle third of the nose
Eligibility Criteria
You may not qualify if:
- Absence of nasal obstruction;
- Previous nasosinusal surgery;
- Symmetrical or asymmetric insufficiency of the middle third that would justify the placement of middle third grafts for the treatment of these problems;
- Presence of nasal valve insufficiency as the only cause of nasal obstruction;
- Cranio-facial anomalies;
- Presence of nasosinusal tumors;
- Active acute rhinosinusitis;
- Patients undergoing treatment of other entities concomitant to rhinoseptoplasty such as: sinus inflammatory surgery, adenoid hypertrophy removal, septal perforation correction, otoplasty or blepharoplasty.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Raphaella Migliavacca
Porto Alegre, Rio Grande do Sul, 90480030, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michelle Lavinsky-Wolff, PhD
Federal University of Health Science of Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2020
First Posted
August 5, 2020
Study Start
October 3, 2018
Primary Completion
March 1, 2021
Study Completion
June 1, 2021
Last Updated
August 5, 2020
Record last verified: 2020-07