Cleft Palate, Fistula of Soft Palate (Disorder), Maxillar Hypoplasia
Conditions
Keywords
LIMA Protocol, cleft palate, palatoplasty, cleft palate repair, palatal fistula, maxillary growth restriction
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 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.
Interventions
PROCEDURELIMA protocol
Cleft palate repair using Hybrid / One-flap technique
PROCEDURERSCM Protocol
Cleft palate repair using Two-flap technique
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Months to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maxillary Size Indicators Observed From Dental Casts | From the time of surgery until 6 months post-operatively | 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) |
| Palatal Fistula by Pittsburgh Classification | From the time of surgery until 6 months post-operatively | 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. |
Countries
Indonesia
Outcome results
None listed