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

Nasal Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04499469
• Other study ID #: 91672218400005327
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Michelle Lavinsky-Wolff, PhD
• Phone: 555133598249
• Email: mlavinsky[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 rhinoseptoplasty without the placement of these grafts?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Obstruction
• Rhinoplasty

Intervention

Procedure:
• Spreader Graft
To place and attach with 5.0 PDS suture 2 grafts in the middle third of the nose

Locations

Country	Name	City	State
Brazil	Raphaella Migliavacca	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	180 postoperative days
Secondary	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.	180 postoperative days
Secondary	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	Base line and 180 postoperative days
Secondary	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	7 until 180 postoperative days
Secondary	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.	Base line and 180 postoperative days