Intermediate cleft rhinoplasty for children with unilateral cleft lip
Intermediate Cleft Rhinoplasty in Unilateral Cleft Lip Patients: Approaches and Outcomes
This study is testing a new way to improve the noses of children with a specific type of cleft lip to see if it makes them look and breathe better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 1 Year to 13 Years |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Trial ID | NCT06127953 on ClinicalTrials.gov |
What this trial studies
This prospective study involves 20 patients with unilateral cleft lip nasal deformity, focusing on an open approach intermediate rhinoplasty using a hybrid technique that combines Potter, Dibbell, and Tajima methods. The aim is to develop an algorithmic approach for managing nasal deformities associated with unilateral cleft lip and to evaluate both aesthetic and functional outcomes. The study will adhere to ethical guidelines, ensuring patient confidentiality and informed consent. Lip revision may also be performed if necessary during the rhinoplasty procedure.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 13 years with repaired unilateral cleft lip and residual nasal deformity.
Not a fit: Patients with bilateral cleft lip or those who have previously undergone lip or nose revision may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the aesthetic and functional outcomes for children with unilateral cleft lip nasal deformities.
How similar studies have performed: While there has been ongoing debate regarding the timing and techniques for cleft rhinoplasty, previous studies have shown varying degrees of success with similar approaches, suggesting this study may build on established methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with repaired unilateral cleft lip with or without cleft palate with residual nasal deformity. * Patients aged 1 to 13 years. * Patients who underwent or did not undergo primary rhinoplasty during the cleft lip repair. Exclusion Criteria: * Patients with bilateral cleft lip. * Patients who underwent lip/nose revision. * Patients or parents' refusal to participate in the study.
Where this trial is running
Sohag
- Faculty of Medicine Sohag University — Sohag, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Elsayed Abdelmonem, MSc
- Email: mohamedelsayedhamad@gmail.com
- Phone: +201013414134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.