NCT07137169

LIMA Protocol Towards Palatal Fistula and Maxillary Growth in Cleft Palate

LIMA Protocol Towards Palatal Fistula and Maxillary Growth in Cleft Palate: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 9 Months – 24 Months
• Healthy volunteers: Not accepted

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 III-IV cleft palate at Cipto Mangunkusumo Hospital from January 2022 to December 2024.

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 protocol offers a refined classification and tailored surgical approach, with promising results in reducing these complications. Methods: This study is a randomized controlled trial comparing palatoplasty techniques based on the LIMA protocol (Hybrid and one-flap techniques) versus the RSCM protocol (two-flap technique) in terms of surgical outcomes: palatal fistula and maxillary growth. The study was conducted at Cipto Mangunkusumo Hospital (RSCM) from January 2022 to December 2024. Samples were collected consecutively, with all subjects who met the inclusion criteria (patients aged 9 months-2 years with unilateral Veau III-IV cleft palate undergoing primary palatoplasty at RSCM) randomly allocated into two study groups. Data were analyzed using T-test and Mann-Whitney U test.

Conditions

• Cleft Palate
• Fistula of Soft Palate (Disorder)
• Maxillar Hypoplasia

Interventions

Type	Name	Description
PROCEDURE	LIMA protocol	Cleft palate repair using Hybrid / One-flap technique
PROCEDURE	RSCM Protocol	Cleft palate repair using Two-flap technique

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2025-08-22
• Last updated: 2025-08-22

Locations

1 site across 1 country: Indonesia