Status:
COMPLETED
LIMA Protocol Towards Palatal Fistula and Maxillary Growth in Cleft Palate
Lead Sponsor:
Indonesia University
Conditions:
Cleft Palate
Fistula of Soft Palate (Disorder)
Eligibility:
All Genders
9-24 years
Phase:
NA
Brief Summary
This randomized controlled trial compared palatoplasty outcomes using the LIMA protocol (Hybrid and one-flap techniques) versus the RSCM protocol (two-flap technique) in patients with unilateral Veau ...
Detailed Description
Background: Palatoplasty in patients with cleft palate carries risks of palatal fistula and impaired maxillary growth, both of which are influenced by cleft severity and surgical technique. The LIMA p...
Eligibility Criteria
Inclusion
- Patients with complete unilateral cleft lip and palate aged 9 months to 2 years who agreed to be research subjects
- Patients with complete unilateral cleft lip and palate who underwent palatoplasty surgery at Cipto Mangunkusumo Hospital
Exclusion
- Patients who refuse to be research subjects and do not want to sign consent form
- Patients with complete unilateral cleft lip and palate who have previously undergone cleft palate repair/ palatoplasty
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT07137169
Start Date
January 1 2022
End Date
December 31 2024
Last Update
August 22 2025
Active Locations (1)
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1
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia, 10430