​​A Randomised Control Study comparing Primary versus Rotational Flap Closure in Pediatric Open Neural Tube Defect Closure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Rates of dehiscence, infection, cerebrospinal fluid leakage, operative duration, the need for a second surgery, length of hospital stay
研究概览
简要总结
It is anticipated in this randomised control trial, that rotational flap closure will demonstrate comparable or superior outcomes in terms of reduced rates of dehiscence, wound infection, cerebrospinal fluid leakage, and the need for a second surgery when compared to primary closure and this may reduce the morbidity altogether in a one-time procedure with comparable operative duration. Additionally, if rotational flap closure proves to be a viable alternative, a shorter hospital stay is expected for infants undergoing this procedure. The study aims to provide valuable insights into refining the surgical management of open neural tube defects in infants, potentially influencing future clinical practices and improving the overall quality of care for these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 3.00 Month(s)(—)
- 性别
- All
入选标准
- •Infants under 3 months of age Diagnosis of open neural tube defect of defect size greater than 5cm longest diameter of skin defect which is measured after dural closure on the OT table Consent from parents or legal guardians obtained.
排除标准
- •Patients with ONTDs of over 3 months of age Patients with closed neural tube defects Lack of parental or legal guardian consent.
结局指标
主要结局
Rates of dehiscence, infection, cerebrospinal fluid leakage, operative duration, the need for a second surgery, length of hospital stay
时间窗: Assessment at baseline after surgery and at follow up after 1 month, 6 months
次要结局
- Rates of dehiscence, infection, cerebrospinal fluid leakage, operative duration, the need for a second surgery, length of hospital stay(by 1 year of follow up)
研究者
Dr Shubhalaxmi Nayak
Department of Pediatric Surgery, AIIMS Jodhpur
