A Retrospective Observational Study Evaluating Surgical Strategies and Safety Profiles of Cochlear Implantation in Pediatric Patients With CHARGE Syndrome
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- "Characterization of Cochlear and Temporal Bone Anatomical Abnormalities in Pediatric Patients With CHARGE Syndrome"
概览
简要总结
This retrospective observational study aims to evaluate cochlear anatomy, surgical challenges, and strategic approaches for safe cochlear implantation in pediatric patients with CHARGE syndrome. CHARGE syndrome is frequently associated with complex temporal bone malformations, which may increase the risk of intraoperative complications and limit the applicability of standard surgical techniques.
The investigators reviewed preoperative imaging findings, operative records, and perioperative clinical data from pediatric patients with CHARGE syndrome who underwent cochlear implantation at Seoul National University Bundang Hospital. The objective of this study is to identify anatomical variations, characterize surgical difficulties, and describe practical surgical strategies that may enhance safety during cochlear implantation in this high-risk population.
The findings of this study are expected to contribute to improved understanding of cochlear and temporal bone anatomy in CHARGE syndrome and to support safer and more effective surgical planning for affected pediatric patients.
详细描述
This retrospective observational study evaluates surgical strategies and safety profiles of cochlear implantation in pediatric patients diagnosed with CHARGE syndrome. Medical records, preoperative imaging studies (CT and/or MRI), and operative reports were retrospectively reviewed to assess cochlear and temporal bone anatomy, surgical challenges, and intraoperative findings.
The study focuses on identifying anatomical variations commonly encountered in CHARGE syndrome and describing practical surgical approaches used to manage complex inner ear and temporal bone malformations. No interventions were assigned as part of this observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Pediatric patients diagnosed with CHARGE syndrome
- •Underwent cochlear implantation at Seoul National University Bundang hospital
- •Availability of preoperative imaging (CT and/or MRI)
- •Complete operative records available
排除标准
- •Patients with CHARGE syndrome who did not undergo cochlear implantation
结局指标
主要结局
"Characterization of Cochlear and Temporal Bone Anatomical Abnormalities in Pediatric Patients With CHARGE Syndrome"
时间窗: Preoperative (Baseline)
This outcome evaluates the type and severity of cochlear, vestibular, and temporal bone malformations based on retrospective review of preoperative radiologic imaging, including computed tomography (CT) and magnetic resonance imaging (MRI), as documented in existing medical records.
次要结局
未报告次要终点
研究者
Choi Byung Yoon
Professor of Otolaryngology-Head and Neck Surgery Investigator Affiliation: Seoul National University Bundang Hospital
Seoul National University Bundang Hospital