- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07317947
Lateral Crural Steal With Columellar Strut Graft in Primary Open Rhinoplasty (LCS/CS)
The Effect of Lateral Crural Steal With Columellar Strut Graft on Nasal Tip Projection and Rotation in Primary Open Rhinoplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rhinoplasty is one of the most commonly performed aesthetic procedures worldwide, with the nasal tip being the most challenging aspect of it. The nasal tip represents the most anterior projecting point of the nose and is formed by the junction of the medial and lateral crura of lower lateral cartilages.
Projection, rotation, and definition are key aspects to be controlled and achieved in the nasal tip surgery. Preservation of natural tip support is a fundamental requirement of a successful rhinoplasty.
Although excisional techniques can produce reductions in lobular width, long-term contour alterations are unpredictable and subject to stigmatic tip deformity. As a consequence, aggressive excision-based techniques are increasingly recognized as haphazard, unpredictable, and disproportionately prone to undesirable postoperative contour deformities.
The lateral crural steal (LCS) is a tissue-conservative technique of nasal tip refinement through relocation of domal apices. Hence, modifying nasal tip projection and rotation. However, the long-term stability of tip position with LCS alone can be variable. To enhance support and long-term maintenance of tip projection, a columellar strut graft -placed between the medial crura- acts as a central scaffold, unifying the nasal tip and helping to control the final nasal tip position.
The lateral crural steal technique alone can achieve improvements in nasal tip projection and rotation, but with weak medial crura, it can twist or compress down the medial crura, which will result in loss of tip height. So, in the technique being studied, combining the LCS with a columellar strut graft can provide both dynamic and static support to the nasal tip.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Elsaeed Habib
- Phone Number: +201094661161
- Email: aelsaeid11@gmail.com
Study Locations
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Kafr ash Shaykh, Egypt, 33511
- Recruiting
- Kafrelsheikh University Hospital
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Contact:
- Ahmed Elsaeed Habib
- Phone Number: +201094661161
- Email: aelsaeid11@gmail.com
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Principal Investigator:
- Ahmed Elsaeed Habib
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- Patients with facial skeletal or developmental abnormalities e.g. maxillary hypoplasia, maxillary prognathism, dentofacial deformities.
- Patients with psychiatric illness or Body Dysmorphic Disorder.
- Significant medical comorbidities contraindicating elective surgery or general anesthesia.
- Inability to provide informed consent or comply with follow-up.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Primary Open Rhinoplasty
Lateral crural steal with columellar strut graft will be done in patients undergoing Primary Open Rhinoplasty
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Patients 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nasal tip projection.
Time Frame: Analysis will be done preoperatively, immediate postoperatively, and at 6-month and 1-year postoperatively.
|
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. |
Analysis will be done preoperatively, immediate postoperatively, and at 6-month and 1-year postoperatively.
|
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Nasal tip rotation
Time Frame: Analysis will be done preoperatively, immediate postoperatively, and at 6-month and 1-year postoperatively.
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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. |
Analysis will be done preoperatively, immediate postoperatively, and at 6-month and 1-year postoperatively.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient's satisfaction
Time Frame: The questionnaire will be conducted pre-operatively (as a baseline), 3-month and 1-year postoperatively.
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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.
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The questionnaire will be conducted pre-operatively (as a baseline), 3-month and 1-year postoperatively.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Safwat Adel Hegazy, Kafrelsheikh University
- Study Chair: Khaled Ahmed Ismail, Kafrelsheikh University
Publications and helpful links
General Publications
- Mulafikh DS, Alharethy SE, Alqabbani AA, Mesallam TA. Validation and clinical application of the Arabic rhinoplasty outcomes evaluation questionnaire. Saudi Med J. 2021 Jun;42(6):655-659. doi: 10.15537/smj.2021.42.6.20210038.
- Alsarraf R. Outcomes research in facial plastic surgery: a review and new directions. Aesthetic Plast Surg. 2000 May-Jun;24(3):192-7. doi: 10.1007/s002660010031.
- Apaydin F, Akyildiz S, Hecht DA, Toriumi DM. Rhinobase: a comprehensive database, facial analysis, and picture-archiving software for rhinoplasty. Arch Facial Plast Surg. 2009 May-Jun;11(3):209-11. doi: 10.1001/archfacial.2009.35. No abstract available.
- Cetiner H. The Effect of Anchoring the Columellar Strut Graft to the Lateral Crural Steal Suture in Patients With a Low Nasal Tip: A New Technique. J Craniofac Surg. 2019 Mar/Apr;30(2):437-441. doi: 10.1097/SCS.0000000000005110.
- Davis RE. Lateral crural tensioning for refinement of the wide and underprojected nasal tip: rethinking the lateral crural steal. Facial Plast Surg Clin North Am. 2015 Feb;23(1):23-53. doi: 10.1016/j.fsc.2014.09.003.
- Kridel RW, Konior RJ, Shumrick KA, Wright WK. Advances in nasal tip surgery. The lateral crural steal. Arch Otolaryngol Head Neck Surg. 1989 Oct;115(10):1206-12. doi: 10.1001/archotol.1989.01860340060018.
- Sepehr A, Alexander AJ, Chauhan N, Chan H, Adamson PA. Cephalic positioning of the lateral crura: implications for nasal tip-plasty. Arch Facial Plast Surg. 2010 Nov-Dec;12(6):379-84. doi: 10.1001/archfacial.2010.87.
- Toriumi DM. New concepts in nasal tip contouring. Arch Facial Plast Surg. 2006 May-Jun;8(3):156-85. doi: 10.1001/archfaci.8.3.156.
- Westreich RW, Lawson W. The tripod theory of nasal tip support revisited: the cantilevered spring model. Arch Facial Plast Surg. 2008 May-Jun;10(3):170-9. doi: 10.1001/archfaci.10.3.170.
- Moubayed SP, Abou Chacra Z, Kridel RW, Ahmarani C, Rahal A. Precise anatomical study of rhinoplasty: description of a novel method and application to the lateral crural steal. JAMA Facial Plast Surg. 2014 Jan-Feb;16(1):25-30. doi: 10.1001/jamafacial.2013.1416.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KFSIRB200-725
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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