Outcomes of Pediatric Robotic Surgery at a Tertiary Children's Hospital: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Postoperative Complications Within 30 Days
研究概览
简要总结
This is a single-center retrospective observational cohort study evaluating surgical and clinical outcomes in pediatric patients undergoing robotic surgery at a tertiary children's hospital.
All consecutive patients younger than 18 years who underwent robotic-assisted procedures (digestive, urologic, gynecologic, or thoracic surgery) between January 2025 and December 2025 at Meyer Children's Hospital IRCCS will be included.
The primary objective is to describe postoperative complications within 30 days. Secondary objectives include conversion to open surgery, reintervention and readmission rates, length of hospital stay, postoperative pain, recovery parameters, and recurrence of the underlying disease within 12 months.
Data will be collected retrospectively from electronic medical records, operative registries, laboratory reports, and follow-up documentation up to 12 months after surgery.
详细描述
Robotic-assisted surgery has progressively expanded in pediatric practice over the past two decades, particularly in urology and increasingly in general, thoracic, and gynecologic pediatric surgery. While several case series and meta-analyses have demonstrated feasibility and safety in selected procedures, real-world institutional data remain essential to evaluate performance, safety, and outcome variability across different surgical domains.
This study is a monocentric retrospective observational cohort conducted at Meyer Children's Hospital IRCCS. The study population includes all consecutive patients younger than 18 years who underwent robotic-assisted digestive, urologic, gynecologic, or thoracic surgical procedures between January 2025 and December 2025.
Clinical data will be extracted from routinely collected hospital records, including electronic medical charts, operative registries, laboratory and imaging reports, discharge summaries, and outpatient follow-up documentation.
The primary outcome is the occurrence of postoperative complications within 30 days, classified according to the Clavien-Dindo grading system when applicable.
Secondary outcomes include:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 18 years at the time of surgery
- •Underwent robotic-assisted surgical procedure (digestive, urologic, gynecologic, or thoracic surgery)
- •Surgery performed between January 2025 and December 2025 at Meyer Children's Hospital IRCCS
- •Availability of essential clinical and perioperative data in the medical record
排除标准
- •Missing essential clinical or postoperative data required for analysis
- •Documented opposition to the use of clinical data for research purposes
研究组 & 干预措施
Pediatric Robotic Surgery Cohort
Pediatric patients (<18 years) undergoing robotic surgery (digestive, urologic, gynecologic, or thoracic procedures) between January 2025 and December 2025 at Meyer Children's Hospital IRCCS.
结局指标
主要结局
Postoperative Complications Within 30 Days
时间窗: 30 days after surgery
Occurrence of postoperative complications within 30 days after robotic-assisted surgery, classified according to the Clavien-Dindo grading system when applicable and documented in the medical record.
次要结局
- Reintervention Rate(30 days after surgery)
- Hospital Readmission Rate(30 days after discharge)
- Postoperative Pain (VAS Score)(72 hours after surgery)
- Time to Resumption of Oral Feeding(Within 48 hours after surgery)
- Recurrence of Underlying Disease(Within 12 months after surgery)
研究者
Riccardo Coletta
MEDICAL DOCTOR
Meyer Children's Hospital IRCCS