Laparoscopic-Assisted Transanal Pull-Through for Hirschsprung Disease in Pediatric:Short and Intermediate Outcomes of Two Different Techniques
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- postoperative bowel function score
研究概览
简要总结
Compare the functional and surgical outcomes of laparoscopic-assisted Swenson-like (LASwL) and laparoscopic-assisted Soave (LASo) pull through in children with HD.
详细描述
A prospective, randomized study was conducted involving 80 patients diagnosed with HD at Al-Azhar University Hospitals over a 48-month period from September 2020 to August 2024. Participants were randomly allocated to the LASwL (Group A) or LASo (Group B). The primary outcome was the postoperative bowel function score. Secondary outcomes included operative time, blood loss, duration of hospital stay, and incidence of postoperative Hirschsprung-associated enterocolitis (HAEC).
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Month 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants and children diagnosed with Hirschsprung's disease (HD) at the Department of Pediatric Surgery, Al-Azhar University Hospitals, from September 2020 to August 2024
排除标准
- •Patients with ultrashort or total colonic aganglionosis and those who had previously undergone pull-through procedures
研究组 & 干预措施
Group B
20 patients with HD
干预措施: laparoscopic-assisted Soave (LASo) (Procedure)
Group A
20 patients with HD
干预措施: laparoscopic-assisted Swenson-like (LASwL) (Procedure)
结局指标
主要结局
postoperative bowel function score
时间窗: 2 years
This assessment evaluated the ability to hold back defecation, the ability to feel or report the urge to defecate, the frequency of defecation, soiling accidents, constipation, and social issues. Most items are scored on a 0-3 scale, while defecation frequency is scored 1-2, resulting in a maximum total score of 20. A higher score indicates better bowel function, with Scores ranged from 17-20 (excellent), 12-16 (good), 9-11 (fair), and less than 8 (poor)
次要结局
未报告次要终点
研究者
Mohamed Abdelmaboud
assistant professor
Al-Azhar University