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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
35
Cleft palate repair using Hybrid / One-flap technique
Cleft palate repair using Two-flap technique
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Maxillary Size Indicators Observed From Dental Casts
Maxillary growth is assessed by measuring its size based on indicators obtained from dental casts before surgery, 1 month post-surgery, and 6 months post-surgery. There will be 4 indicators, namely: 1. 'CC = primary inter-canine width 2. 'TT = inter-tuberosity width 3. 'ICC = length from incisivus to the 'CC line (indicating anterior palatal length) 4. 'ITT = length from incisivus to the 'TT line (indicating overall palatal length)
Time frame: From the time of surgery until 6 months post-operatively
Palatal Fistula by Pittsburgh Classification
A palatal fistula is an abnormal opening in the palate that persists or develops after cleft palate repair, creating a connection between the oral and nasal cavities, excluding openings due to wound/ suture dehiscence. The location of opening will be Classified using Pittsburgh Classification; Type I: uvula; Type II: soft palate; Type III: junction between the soft and hard palate; Type IV: hard palate; Type V: junction between the primary and secondary palate; Type VI: lingual-alveolar; Type VII: labial-alveolar.
Time frame: From the time of surgery until 6 months post-operatively
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