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The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment

Primary Purpose

Rhinoplasty, Nasal Obstruction

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Spreader Graft
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinoplasty

Eligibility Criteria

14 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients eligible for reduction rhinoseptoplasty who agreed to participate in the study and who did not meet the exclusion criteria

Exclusion Criteria:

  • 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.

Sites / Locations

  • Raphaella MigliavaccaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Spreader Graft

Without Spreader Graft

Arm Description

Placement and attachment with 5.0 polydioxanone (PDS) suture 2 grafts in the middle third of the nose

No engraftment in the middle third

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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
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.

Full Information

First Posted
July 21, 2020
Last Updated
July 31, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT04499469
Brief Title
The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment
Official Title
The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoplasty, Nasal Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spreader Graft
Arm Type
Experimental
Arm Description
Placement and attachment with 5.0 polydioxanone (PDS) suture 2 grafts in the middle third of the nose
Arm Title
Without Spreader Graft
Arm Type
No Intervention
Arm Description
No engraftment in the middle third
Intervention Type
Procedure
Intervention Name(s)
Spreader Graft
Other Intervention Name(s)
Middle Third Grafts
Intervention Description
To place and attach with 5.0 PDS suture 2 grafts in the middle third of the nose
Primary Outcome Measure Information:
Title
Nasal Obstruction Symptom Evaluation Scale (NOSE)
Description
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.
Time Frame
180 postoperative days
Secondary Outcome Measure Information:
Title
Rhinoplasty Outcome Evaluation (ROE) Scale
Description
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.
Time Frame
180 postoperative days
Title
Visual Analogue Scale - Nasal Obstruction
Description
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.
Time Frame
180 postoperative days
Title
Clinical Diagnosis of Allergic Rhinitis
Description
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
Time Frame
Base line and 180 postoperative days
Title
Complications
Description
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
Time Frame
7 until 180 postoperative days
Title
Anterior Rhinoscopy and Nasal Endoscopy
Description
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.
Time Frame
Base line and 180 postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients eligible for reduction rhinoseptoplasty who agreed to participate in the study and who did not meet the exclusion criteria Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Lavinsky-Wolff, PhD
Phone
555133598249
Email
mlavinsky@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Raphaella Migliavacca, MsC
Phone
555133598249
Email
raphaellamigliavacca@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Lavinsky-Wolff, PhD
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Raphaella Migliavacca
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90480030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphaella Migliavacca, MsC
Phone
555133598249
Email
raphaellamigliavacca@gmail.com
First Name & Middle Initial & Last Name & Degree
Michelle Lavinsky-Wolff, PhD
Phone
555133598249
Email
mlavinsky@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment

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