Rhinoplasty in Patients with Cleft Lip Nasal Deformity: Correcting the Alar Base.
Samuel R DeVictor, Travis T Tollefson
https://pubmed.ncbi.nlm.nih.gov/37433309Actively Recruiting
Phase Not Applicable
Age: 5Years - 18Years
All Genders
Healthy Volunteers
ID06510881
Single Stage Versus Multiple Staged Repair of Nasal and Alveolar Deformities in Patients With Cleft Lip and Palate
Led by Assiut University · Updated on 2024-07-19
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare single-stage repair versus multiple staged repair of nasal and alveolar deformities in patients with cleft lip and palate. These patients often have noticeable nasal deformities and dental problems due to interrupted muscle insertions and bone defects. The study explores whether repairing both the nose and alveolar bone together can reduce surgical burden and improve facial symmetry faster than staged repairs. Participants are randomly divided into two groups. Group 1 includes patients aged 8 years or older who receive combined rhinoplasty with cartilage strut support and alveolar bone reconstruction using an iliac bone graft. Group 2 includes younger patients who have rhinoplasty alone first, with planned alveolar repair at a later session. Surgeries are done under general anesthesia by the same team, with postoperative care including wound management and medications. Patients undergo preoperative evaluations including medical history, nasal and dental assessments using the SCHNOS criteria, CT scans, lab tests, and facial photographs. Outcomes are assessed 6 months after surgery to compare cosmetic and functional improvements. The main measure is the change in SCHNOS scores evaluating nasal function and appearance. This study lasts at least 6 months post-surgery for each participant to monitor results and recovery.
CONDITIONS
Brief Title
Single Stage Versus Multiple Staged Repair of Nasal & Alveolar Deformities in Patients With Cleft Lip and Palate
Who Can Participate
Age: 5Years - 18Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients with unilateral cleft lip and palate deformities with evident nasal and cleft lip and palate aged between 5 - 18 years.
You will not qualify if you...
- Patients with bilateral complete cleft palate.
- Patients with only cleft lip.
- Patients with cleft secondary palate.
- Patients non fit for surgery.
- Patients refuse the consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Surgery with follow-up for 6 months
Participants undergo either combined rhinoplasty and alveolar repair if aged 8 years or older, or rhinoplasty alone with planned alveolar repair in a later session if younger than 8 years. Surgery is performed under general anesthesia with post-operative care including wound care, oral hygiene, and medications.
1 surgery visit and follow-up visits over 6 months
Follow-up
Duration - Up to 6 months after surgery
Participants are assessed 6 months post-operatively for functional and cosmetic outcomes based on the SCHNOS criteria and standard facial photographs.
Approximately 1 to 2 follow-up visits over 6 months
Trial Site Locations
Total: 1 location
1
Assiut university
Asyut, Egypt
Actively Recruiting
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Research Team
M
Mohammed Ramadan, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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S M Balaji
https://pubmed.ncbi.nlm.nih.gov/27563610Unilateral cleft lip repair: an anatomical subunit approximation technique.
David M Fisher
https://pubmed.ncbi.nlm.nih.gov/15988248Modified Activation Technique for Nasal Stent of Nasoalveolar Molding Appliance for Columellar Lengthening in Bilateral Cleft Lip/Palate.
Pravinkumar G Patil, Smita P Nimbalkar-Patil
https://pubmed.ncbi.nlm.nih.gov/27002917Secondary Cleft Rhinoplasty.
David Liao, Nicola Pereira, Adetokunbo Obayemi...
https://pubmed.ncbi.nlm.nih.gov/37981415