Comparing single and multiple surgeries for nasal and alveolar repairs in cleft lip and palate patients
Official title: Single Stage Versus Multiple Staged Repair of Nasal & Alveolar Deformities in Patients With Cleft Lip and Palate
Run by Assiut University · NCT06510881 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 18 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Status | Recruiting |
| Started | July 20, 2024 |
| Main results expected | February 20, 2026 |
| Study ends | February 20, 2027 |
| Registry record updated | July 19, 2024 |
| Trial ID | NCT06510881 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 5 to 18 with unilateral cleft lip and palate deformities.
✕Probably not a fit
Patients with bilateral complete cleft palate or those with only cleft lip may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown varying success with similar surgical approaches, but this specific comparison is novel.
Who can join: the full rules
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 it's running
-
Assiut university
Asyut, Egypt Recruiting
Study contacts
- Study coordinator: Mohammed Ramadan, Master
- Email: mhmdrmdn1994@gmail.com
- Phone: 01024529525
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.