Comparing single and multiple surgeries for nasal and alveolar repairs in cleft lip and palate patients
Single Stage Versus Multiple Staged Repair of Nasal & Alveolar Deformities in Patients With Cleft Lip and Palate
This study is testing whether doing all the necessary nose and gum repairs in one surgery is better than spreading them out over multiple surgeries for kids with cleft lip and palate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Trial ID | NCT06510881 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a single-stage surgical approach versus a multiple-stage approach for repairing nasal and alveolar deformities in patients with cleft lip and palate. Patients aged 5 to 18 with unilateral cleft lip and palate will be randomly assigned to either receive combined rhinoplasty and alveolar repair or undergo alveolar repair alone with a planned rhinoplasty later. The study will assess outcomes using clinical evaluations, radiological imaging, and standardized surveys to measure cosmetic and functional improvements. The goal is to determine if a single-stage repair offers advantages over traditional staged repairs.
Who should consider this trial
Good fit: Ideal candidates are patients aged 5 to 18 with unilateral cleft lip and palate deformities.
Not a fit: Patients with bilateral complete cleft palate or those with only cleft lip may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved cosmetic and functional outcomes for patients with cleft lip and palate.
How similar studies have performed: Previous studies have shown varying success with similar surgical approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Patients with unilateral cleft lip and palate deformities with evident nasal and cleft lip and palate aged between 5 - 18 years. Exclusion Criteria: * \* 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.
Where this trial is running
Asyut
- Assiut university — Asyut, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohammed Ramadan, Master
- Email: mhmdrmdn1994@gmail.com
- Phone: 01024529525
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.