NCT07317947

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Jan 2026Feb 2027

First Submitted

Initial submission to the registry

December 19, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

December 19, 2025

Last Update Submit

January 8, 2026

Conditions

Keywords

RhinoplastyLateral crural stealColumellar strutRhinobaseRhinoplasty Outcome Evaluation

Outcome Measures

Primary Outcomes (2)

  • 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.

    Analysis will be done preoperatively, immediate postoperatively, and at 6-month and 1-year postoperatively.

  • 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.

    Analysis will be done preoperatively, immediate postoperatively, and at 6-month and 1-year postoperatively.

Secondary Outcomes (1)

  • Patient's satisfaction

    The questionnaire will be conducted pre-operatively (as a baseline), 3-month and 1-year postoperatively.

Study Arms (1)

Primary Open Rhinoplasty

EXPERIMENTAL

Lateral crural steal with columellar strut graft will be done in patients undergoing Primary Open Rhinoplasty

Procedure: Lateral crural steal with columellar strut graft in Primary Open Rhinoplasty

Interventions

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.

Primary Open Rhinoplasty

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University Hospital

Kafr ash Shaykh, 33511, Egypt

RECRUITING

Related Publications (10)

  • 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.

    PMID: 34078728BACKGROUND
  • 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.

    PMID: 10890946BACKGROUND
  • 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.

    PMID: 19451458BACKGROUND
  • 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.

    PMID: 30614999BACKGROUND
  • 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.

    PMID: 25430927BACKGROUND
  • 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.

    PMID: 2789776BACKGROUND
  • 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.

    PMID: 21079114BACKGROUND
  • 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.

    PMID: 16702528BACKGROUND
  • 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.

    PMID: 18490543BACKGROUND
  • 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.

    PMID: 24177341BACKGROUND

Study Officials

  • Safwat Adel Hegazy

    Kafrelsheikh University

    STUDY DIRECTOR
  • Khaled Ahmed Ismail

    Kafrelsheikh University

    STUDY CHAIR

Central Study Contacts

Ahmed Elsaeed Habib

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Plastic Surgery Resident

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 5, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations