LIMA Protocol Towards Palatal Fistula and Maxillary Growth in Cleft Palate: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Maxillary Size Indicators Observed From Dental Casts
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Maxillary Size Indicators Observed From Dental Casts
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Kristaninta Bangun
Principal Investigator, Head of Plastic and Reconstructive Surgery Division
Indonesia University