RhinoplastyNCT04499469
The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment
A study testing Spreader Graft in people with Rhinoplasty and Nasal Obstruction, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinoplasty, Nasal Obstruction
- What is being tested?
- Spreader Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Oct 2018to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients eligible for reduction rhinoseptoplasty who agreed to participate in the study and who did not meet the exclusion criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Raphaella Migliavacca
Porto Alegre, Rio Grande do Sul, 90480030
Raphaella Migliavacca, MsC, 555133598249, raphaellamigliavacca@gmail.com
Michelle Lavinsky-Wolff, PhD, 555133598249, mlavinsky@gmail.com
About this study
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?
Read the detailed description
Reduction rhinoplasty and rhinoseptoplasty are among the most accomplished aesthetic procedures in Plastic Surgery and Otorhinolaryngology. Nasal obstruction is one of the majors concerns in this procedures, because it affects quality of life and surgical outcomes. Nasal surgeons have paid much attention to nasal valve area to prevent nasal obstruction and some assert reconstruction of the middle vault after dorsal reduction with grafts. The gold standard for middle vault reconstruction after dorsal reduction has been the spreader graft, first advocated by Sheen. Studies in surgical techniques for the treatment of nasal valve collapse focus much more in techniques than in evidence of its efficacy.
- Conditions
- Rhinoplasty, Nasal Obstruction
- Being tested
- Spreader Graft
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spreader GraftProcedure or surgery
Also called Middle Third Grafts
To place and attach with 5.0 PDS suture 2 grafts in the middle third of the nose
| Study group | Role | What they receive |
|---|---|---|
| Spreader Graft | Experimental | Placement and attachment with 5.0 polydioxanone (PDS) suture 2 grafts in the middle third of the nose Receives: Procedure: Spreader Graft |
| Without Spreader Graft | No intervention | No engraftment in the middle third |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 postoperative days
Secondary outcomes (5)
Rhinoplasty Outcome Evaluation (ROE) Scale
The ROE scale is a questionnaire, designed for the evaluation of rhinoplasty results. This instrument is composed of six questions that assess three domains of quality of life: physical, mental / emotional and social. Each question is scored on a scale of 0 to 4 and converted to a total score of 0 to 100, dividing the value by 24 and multiplying by 100. A score above 85 is considered excellent and generally means that the patient is very satisfied. However, the comparison of pre and postoperative values usually provide the most relevant information. Patients will be asked to respond to this scale in the base line and at 30, 90 and 180 postoperative days.
Measured: 180 postoperative days
Visual Analogue Scale - Nasal Obstruction
Patients will be asked to complete an analogue-visual scale indicating the degree of nasal obstruction, with the instrument Visual Analogue Scale (VAS). The VAS for nasal obstruction has 100 mm and this scale will be converted into a scale ranging from 0 to 100, and the value "0" represents no nasal obstruction and the value "100" correspond to the highest nasal obstruction level possible. The scale will be applied in the base line as well as in the 30,90 and 180 postoperative days.
Measured: 180 postoperative days
Clinical Diagnosis of Allergic Rhinitis
A questionnaire of symptoms and intensity based in Allergic Rhinitis and its Impact on Asthma (ARIA) recommendations and treatment of Allergic Rhinitis is applied in the base line and 30, 90 and 180 postoperative days
Measured: Base line and 180 postoperative days
Complications
The protocol includes data such as bleeding, signs of graft detachment, presence of crusts, residual septal deviation, synechiae and septal perforation to be to be evaluated on the 7th, 30th, 90th and 180th postoperative days
Measured: 7 until 180 postoperative days
Anterior Rhinoscopy and Nasal Endoscopy
All patients will be submitted to anterior rhinoscopy and nasal endoscopy using a 0 degree rigid nasal endoscope. The septal deviation will be classified considering the side of maximum deviation (right / left), the severity of the obstruction caused by the septal deviation (<25% of obstruction, 25-50% of obstruction, 50-75% of obstruction;> 75% of obstruction) and the location of the point of greatest deviation based on the classification of the five Cottle areas.
The evaluation of this outcome will be performed in the preoperative consultation, 30, 90 and 180 after the surgery.
Measured: Base line and 180 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start3 Oct 2018
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoplastyStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Lavinsky-Wolff, PhD, Study director, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499469
- Sponsor's protocol ID
- 91672218400005327
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment
- ClinicalTrials.gov ID
- NCT04499469
- Acronym / sponsor ID
- 91672218400005327
- Conditions
- Rhinoplasty, Nasal Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Reduction rhinoplasty and rhinoseptoplasty are among the most accomplished aesthetic procedures in Plastic Surgery and Otorhinolaryngology. Nasal obstruction is one of the majors concerns in this procedures, because it affects quality of life and surgical outcomes. Nasal surgeons have paid much attention to nasal valve area to prevent nasal obstruction and some assert reconstruction of the middle vault after dorsal reduction with grafts. The gold standard for middle vault reconstruction after dorsal reduction has been the spreader graft, first advocated by Sheen. Studies in surgical techniques for the treatment of nasal valve collapse focus much more in techniques than in evidence of its efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spreader Graft | Experimental | Procedure: Spreader GraftPlacement and attachment with 5.0 polydioxanone (PDS) suture 2 grafts in the middle third of the nose |
| Without Spreader Graft | No intervention | –No engraftment in the middle third |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients eligible for reduction rhinoseptoplasty who agreed to participate in the study and who did not meet the exclusion criteria
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spreader GraftAlso: Middle Third GraftsTo place and attach with 5.0 PDS suture 2 grafts in the middle third of the nose | Procedure or surgery | Spreader Graft |
Primary outcome
Nasal Obstruction Symptom Evaluation Scale (NOSE)
Time frame: 180 postoperative days
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.
5 secondary outcomes
Rhinoplasty Outcome Evaluation (ROE) Scale
Time frame: 180 postoperative days
Visual Analogue Scale - Nasal Obstruction
Time frame: 180 postoperative days
Clinical Diagnosis of Allergic Rhinitis
Time frame: Base line and 180 postoperative days
Complications
Time frame: 7 until 180 postoperative days
Anterior Rhinoscopy and Nasal Endoscopy
Time frame: Base line and 180 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Lavinsky-Wolff, PhD study director
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spreader Graft in people with Rhinoplasty and Nasal Obstruction, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Lavinsky-Wolff, PhD (555133598249, mlavinsky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Obstruction Symptom Evaluation Scale (NOSE) (time frame: 180 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.