跳至主要内容
临床试验/CTRI/2024/05/067931
CTRI/2024/05/067931招募中不适用

​​A Randomised Control Study comparing Primary versus Rotational Flap Closure in Pediatric Open Neural Tube Defect Closure

Dr Shubhalaxmi Nayak1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年6月5日最近更新:

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

发起方
Dr Shubhalaxmi Nayak
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shubhalaxmi Nayak

Department of Pediatric Surgery, AIIMS Jodhpur

研究点 (1)

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