deltatrials
Unknown NA INTERVENTIONAL 2-arm NCT03213548

Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty

Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty : A Randomized Clinical Trial

Sponsor: Hospital de Clinicas de Porto Alegre

Updated 6 times since 2017 Last updated: Jul 7, 2017 Started: Sep 15, 2017 Primary completion: Sep 15, 2019 Completion: Sep 15, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03213548, this NA trial focuses on Cicatrix and Healing Scar and remains ongoing. Sponsored by Hospital de Clinicas de Porto Alegre, it has been updated 6 times since 2017, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

The study was performed at the Otorhinolaryngology service Clinicas Hospital of Porto Alegre ( HCPA). Patients who meet the inclusion and exclusion criteria will be invited to participate in the study. All patients who agree to participate in the study, filling out an Informed Consent Form, will have their preoperative consultation registered. Pre- and postoperative follow-up will be performed at the otorhinolaryngology service of HCPA. Patients will be allocated randomly in the intervention and control groups, in blocks of 6, using a computer generated random sequence of numbers. . The allocation will be kept confidential for the patient and for the researchers responsible for measuring the outcomes. intervention group will be submitted to surgical modification of the alar base with incisions in the alar facial groove, the control group will be submitted to a similar technique, but it will save groove. The surgical technique will be based on a sequential approach based on the 2010 publication Adamnson et al in the Archives of Facial Plastic Surgery "Alar Soft-Tissue Techniques in Rhinoplasty Algorithmic Approach, Quantifiable Measurement of outcomes will be performed by trained and blinded research team members for intervention allocation. Patients will be evaluated at the preoperative visit, and will...

The study was performed at the Otorhinolaryngology service Clinicas Hospital of Porto Alegre ( HCPA). Patients who meet the inclusion and exclusion criteria will be invited to participate in the study. All patients who agree to participate in the study, filling out an Informed Consent Form, will have their preoperative consultation registered. Pre- and postoperative follow-up will be performed at the otorhinolaryngology service of HCPA. Patients will be allocated randomly in the intervention and control groups, in blocks of 6, using a computer generated random sequence of numbers. . The allocation will be kept confidential for the patient and for the researchers responsible for measuring the outcomes. intervention group will be submitted to surgical modification of the alar base with incisions in the alar facial groove, the control group will be submitted to a similar technique, but it will save groove.

The surgical technique will be based on a sequential approach based on the 2010 publication Adamnson et al in the Archives of Facial Plastic Surgery "Alar Soft-Tissue Techniques in Rhinoplasty Algorithmic Approach, Quantifiable Measurement of outcomes will be performed by trained and blinded research team members for intervention allocation. Patients will be evaluated at the preoperative visit, and will return to consultations on days 7, 14.30, 60, 90.360 postoperative days, when they will be photographed at the incidences, frontal, ¾ profile, basal, between tip with Eyebrows. At the base line and at 90 postoperative days the following outcomes will be measured: Stony Brook Scale , ROE Scale, Visual Analogue Scale - Satisfaction with aesthetic aspect of the nose, Visual Analogue Scale Intensity of nasal obstruction and NOSE Scale For the comparison of continuous variables will be compared using Student's t test for independent samples or Mann-Whitney non-parametric test, when appropriate. Multivariate analysis will be performed to control confounding factors.

Status Flow

~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshotNot Yet Recruiting~Jun 2018 – ~Oct 2020 · 28 months · monthly snapshotNot Yet Recruiting~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Unknown NA

  2. Jul 2024 — Sep 2024 [monthly]

    Unknown NA

    Status: Unknown StatusUnknown

  3. Jan 2021 — Jul 2024 [monthly]

    Unknown Status NA

  4. Oct 2020 — Jan 2021 [monthly]

    Unknown Status NA

    Status: Not Yet RecruitingUnknown Status

  5. Jun 2018 — Oct 2020 [monthly]

    Not Yet Recruiting NA

Show 1 earlier version
  1. Aug 2017 — Jun 2018 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hospital de Clinicas de Porto Alegre
Data source: Hospital de Clinicas de Porto Alegre

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations