Lateral Crural Steal With Columellar Strut Graft in Primary Open Rhinoplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKafrelsheikh University
About this trial
The goal of this clinical trial is to assess the effect of Lateral crural steal with Columellar strut graft done in Primary Open Rhinoplasty and its long-term sustainability on nasal tip projection and nasal tip rotation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients seeking primary rhinoplasty for aesthetic and/or functional indications.
Presence of inadequate nasal tip projection and/or rotation suitable for correction using lateral crural steal with columellar strut graft.
Ability to provide written informed consent and comply with follow-up visits.
Disqualifiers
History of prior nasal surgery.
History of severe nasal trauma, altering cartilage architecture.
Significant functional nasal obstruction requiring complex external nasal valve reconstruction.
Patients with excessively wide alar base requiring alar base reduction involving vestibular sill excision (to prevent confounding on projection/rotation).
Trial design
Design model
Single group
Treatments tested in this trial
Lateral crural steal with columellar strut graft in Primary Open Rhinoplasty
Procedure/SurgeryPatients undergo primary open rhinoplasty under general anesthesia. After local infiltration, an open approach is performed using an inverted-V transcolumellar incision with bilateral marginal incisions. The skin-soft tissue envelope is elevated in the supra-perichondrial plane. Dorsal deformities are corrected and septoplasty is performed with cartilage harvest. Vestibular skin is undermined and cephalic trimming of the lateral crura is carried out. Lateral crural steal is performed by advancing the medial end of the lateral crus 3-5 mm medially using transdomal sutures after defining the new dome position. A fixed columellar strut graft is inserted between the medial crura and secured to provide central tip support. Interdomal sutures are placed. No additional projection-enhancing grafts are used. Incisions are closed and internal and external nasal splints are applied.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: Primary Open RhinoplastyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Nasal tip projection.
Assessing nasal projection using Goode's ratio, which is the ratio between distance from the alar crease (vertical plane of the alar base) to the tip of the nose and distance from the nasion to the tip of the nose. The ideal ratio is between 0.55 to 0.60. Nasal tip projection will be assessed using Rhinobase® software developed by Apaydin et al (2009), which is a software for rhinoplasty that enables standardized photographic analysis, facilitates precise anthropometric measurements, and provides objective documentation of pre- and postoperative nasal parameters.
Time frame
Analysis will be done preoperatively, immediate postoperatively, and at 6-month and 1-year postoperatively.2
Nasal tip rotation
Assessing nasal tip rotation through measuring the Nasolabial angle which is the angle formed at the junction of the columella and a line drawn from the subnasale to the labrale superius, and the Nasofacial angle which is the angle between the nasal dorsum and the facial plane (glabella to pogonion). Nasal tip rotation will be assessed using Rhinobase® software developed by Apaydin et al (2009), which is a software for rhinoplasty that enables standardized photographic analysis, facilitates precise anthropometric measurements, and provides objective documentation of pre- and postoperative nasal parameters.
Time frame
Analysis will be done preoperatively, immediate postoperatively, and at 6-month and 1-year postoperatively.Secondary outcomes
1
Patient's satisfaction
Assessing patient satisfaction through Rhinoplasty Outcome Evaluation (ROE) Questionnaire; which is a six-question questionnaire used to assess satisfaction with aesthetic and functional results after Rhinoplasty. Each of the six items is scored on a 0-4 scale, with 0 representing the most negative response and 4 representing the most positive response. Therefore, the total score can vary from 0 to 24. In order to facilitate the comprehension of the results, the total score can be divided by 24 and multiplied by 100, so that the score can vary from 0 to 100 %. So, 24 points or 100 % means the most patient satisfaction. It's originally piloted by Alsarraf (2000). The questionnaire has an Arabic-translated version done by Alharethy S, et al. (2021) that will be used.
Time frame
The questionnaire will be conducted pre-operatively (as a baseline), 3-month and 1-year postoperatively.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov