LIMA Protocol Towards Palatal Fistula and Maxillary Growth in Cleft Palate

University of Indonesia (UI)

Status: Completed

Conditions: Maxillar Hypoplasia; Cleft Palate; Fistula of Soft Palate (Disorder)

Treatments: Procedure: LIMA protocol; Procedure: RSCM Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT07137169

LIMAProtocol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 9 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

LIMA Protocol

Experimental group

Description:

LIMA Protocol classifies cases of cleft palate based on the cleft severity (using palatal index), and guide which method of cleft palate repair surgery should be done

Treatment:

Procedure: LIMA protocol

RSCM Protocol

Active Comparator group

Description:

RSCM Protocol guide which method of cleft palate repair surgery should be done in a cleft palate (without classifying based on cleft palate severity/ palatal index)

Treatment:

Procedure: RSCM Protocol