Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst: A Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Surgery Duration
研究概览
简要总结
This is a retrospective cohort study designed to compare the outcomes of open surgery versus laparoscopic surgery in pediatric patients diagnosed with congenital choledochal cyst (CCC). The study includes children who underwent surgery at Guangdong Medical University Affiliated Hospital and Guangzhou Women and Children's Medical Center between January 1, 2010, and September 1, 2024. The aim of this study is to evaluate and compare the surgical outcomes, including surgery duration, intraoperative blood loss, hospital stay, and postoperative complications (e.g., bile leakage and intestinal obstruction), between the two surgical approaches. The data collected from the patient records will be analyzed to identify factors influencing surgical outcomes and to guide future treatment decisions for CCC in pediatric patients.
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 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients diagnosed with congenital choledochal cyst based on preoperative imaging (e.g., ultrasound, computed tomography（CT）, or magnetic resonance cholangiopancreatography（MRCP)）.
- •Patients who underwent either open surgery (open cyst excision and Roux-en-Y hepaticojejunostomy) or laparoscopic surgery (laparoscopic cyst excision and Roux-en-Y hepaticojejunostomy) for the treatment of congenital choledochal cyst.
- •Informed consent for follow-up obtained from the patient's family or legal guardian.
排除标准
- •Patients lacking one or more key outcome measures, including surgery duration, hospital stay, intraoperative blood loss, incidence of postoperative bile leakage, or incidence of postoperative intestinal obstruction.
- •Patients with incomplete clinical data, such as missing sex, age, or other essential demographic information.
- •Patients with coagulation disorders that may interfere with surgery or recovery.
- •Patients with severe comorbidities or immune system disorders that may complicate surgical intervention or recovery.
- •Patients who underwent non-surgical treatment (e.g., endoscopic procedures) for congenital choledochal cyst.
- •Pregnant patients or those who are breastfeeding (if applicable to your study population).
结局指标
主要结局
Surgery Duration
时间窗: Measured intraoperatively, from the initial incision to the closure of the surgical site, at the end of the surgery.
The time required to complete the surgical procedure, from the initial incision to the closure of the surgical site. This is measured in minutes and compared between the open surgery and laparoscopic surgery groups
Postoperative Complications
时间窗: 30 days post-surgery (for short-term complications)
The occurrence of postoperative complications, specifically bile leakage and intestinal obstruction, in patients undergoing either open or laparoscopic surgery. This is measured as a binary outcome (yes/no) and will be compared between the two groups.
Intraoperative Blood Loss
时间窗: Measured intraoperatively, during the surgery, from the initial incision to the closure of the surgical site.
The total amount of blood lost during the surgical procedure, measured in milliliters (mL). This will be compared between the two surgical groups (open surgery and laparoscopic surgery).
Hospital Stay
时间窗: Measured from the day of surgery to discharge, assessed over the duration of hospital stay, up to 30 days post-surgery.
The total number of days the patient stays in the hospital post-surgery until discharge. This is compared between the open surgery and laparoscopic surgery groups.
次要结局
未报告次要终点
研究者
In-Jin Jang
Professor
Hansung University