Evaluation of Facial Growth in Two Primary Protocols Used in the Surgical Treatment of Unilateral Cleft Lip and Palate Patients. A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 主要终点
- Maxillary Growth Evaluated by the Atack Yardstick
研究概览
简要总结
The purpose of this study is to evaluate which surgical protocol for treating Unilateral Cleft Lip and Palate (UCLP), a single or two stage repair ( with hard palate late closure) will have less impact in mid facial growth.
The study hypothesis states that a two stage cleft palate repair , with a late hard palate repair will reduce maxillary growth impairment.
详细描述
The study is being conducted at CADEFI- Centro de Atenção aos Defeitos da Face do IMIP (craniofacial center) in IMIP-Instituto de Medicina Integral Professor Fernando Figueira-, Recife PE- Pernambuco-, Brazil. All children were and will be operated by the same plastic surgeon in the operating room in IMIP. The sample size was calculated in 64 patients, 32 to GI ( one stage repair) and 32 to GII ( two stage repair, with a hard palate late closure), considering taking a statistical power of 90% with a 5% significance, determined with a difference of at least 25% between the two groups. Note : this sample was calculated for the dependent variable commonly present in patients with unilateral lip and palate cleft : atresia of the dental arches.
The groups are numbered in post op care attendance of the lip repair, according to randomization sequence done in computerized statistical program. The randomization is being held after the first month of the lip repair surgery. The surgeon, and parents or guardians (who have already signed the Informed Consent Form) will not have prior access to information on the type of allocation in each group. Subsequently it will be added in patients chart the record set for the patient group.
>Study Variables Independent variables:. Group I (palate closure in two surgical times and GII (closure of the palate in a surgical time) also will be considered independent variables age, sex, birth weight and maternal education.
Dependent variables: the presence of postoperative infection, initial and intermediate cleft sizes, dimensional changes of the transverse arch, the evaluation indexes of dental arch relationship(Goslom,Atack Yardsticks) and speech outcomes evaluation grades
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
- Single (Care Provider)
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unilateral cleft lip and palate admitted consecutively in CADEFI-IMIP between August 1, 2011 and July 31, 2015
排除标准
- •Patients with associated syndromes that retard the neuro-psycho-motor and speech development;
- •Patients without clinical conditions for performing the surgical chronology protocol;
- •Patients whose parents or guardians who are not in accordance with the Informed Consent Statement proposed by the researcher
结局指标
主要结局
Maxillary Growth Evaluated by the Atack Yardstick
时间窗: between 4 to 5 years old
A system that evaluates facial growth , assessing dental arch relationships, and ranking them from 1 to 5, being 1 the best and 5 the worst outcome.Cases are allocated to these categories on a value judgment basis by reference to the anchor groups of the Atack Yardstick. This is performed by external judges, previously trained and evaluated
次要结局
未报告次要终点
研究者
Rui Manuel Rodrigues Pereira
CADEFI Coordinator
Professor Fernando Figueira Integral Medicine Institute