A Prospective Randomized Controlled Trial Comparing Primary Anastomosis and Bishop-Koop Procedure in the Management of Jejunoileal Atresia in Neonates, the Study Will be Done at Pediatric Surgery Unit, Elshatby Alexandria University Hospital in the Period From January 2026 Till January 2028.
A Prospective Randomized Controlled Trial Comparing Primary Anastomosis and Bishop-Koop Procedure in the Management of Jejunoileal Atresia in Neonates
randomized controlled trial comparing two techniques in treatment of neonatal jejuno-ileal atresia
研究概览
详细说明
This study is prospective randomized controlled study parallel-group design, allocation ratio 1:1, stratification by: Jejunal vs ileal atresia,
Inclusion criteria:
- Neonates diagnosed intraoperatively with jejunal or ileal atresia
- Age ≤ 28 days
- Hemodynamically stable
- No gross bowel necrosis requiring extensive resection admitted to pediatric surgery unit, Elshatby Alexandria University hospital in the period from January 2026 till January 2028.
Exclusion criteria:
- Major life-limiting congenital anomalies
- Weight ≤ 2.5 kg
The patients included in the study will be categorized
-
Age
-
Sex
-
type of intestinal atresia
-
Technique done (primary anastomosis with\without tapering vs Bishop Koop)
-
Operative time
-
Post-operative period as regards:
- NGT aspirate
- Early post operative complications such as wound infection, leakage, sepsis
- Onset of feeding
- Bowel motion frequency
- Abdominal distension
- Upper contrast study before discharge
-
Hospital stay duration
-
Need for re-exploration
-
Mortality (30 days)
-
Follow-up visits 3-6 months post discharge.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Dr. Ahmed Maher Fathy Mohamed Khalil, lecturer of pediatric surgery
- 电话号码：+201128087844
- 邮箱：ahmed.maher@alexmed.edu.eg
学习地点
-
-
-
Alexandria、埃及
- 招聘中
- Alexandria University Faculty of Medicine
-
接触：
- Prof.Dr. jihan goefil, professor
- 电话号码：+2034851903
- 邮箱：vd_community@alexmed.edu.eg
-
首席研究员：
- Ahmed Maher Khalil, lecturer of pediatric surgery
-
副研究员：
- mohamed abdelazim aboheba, professor of pediatric surgery
-
副研究员：
- sameh mahmoud shehata, professor of pediatric surgery
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Neonates diagnosed intraoperatively with jejunal or ileal atresia
- Age ≤ 28 days
- Hemodynamically stable
- No gross bowel necrosis requiring extensive resection
Exclusion Criteria:
- Major life-limiting congenital anomalies
- Weight ≤ 2.5 kg
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：jejunal atresia
primary anastmosis or bishop koop |
primary anastomosis with\without tapering Bishop Koop technique |
|
实验性的：ileal atresia
primary anastmosis vs bishop koop |
primary anastomosis with\without tapering Bishop Koop technique |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to full enteral feeding.
大体时间：10 days
|
the time consumed post surgical repair to reach full oral feeding defined as ≥120 ml/kg/day tolerated without parenteral nutrition |
10 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
anastmotic leakage
大体时间：5-7 days
|
leakage after performing anastmosis |
5-7 days
|
|
Mortality (30-day)
大体时间：30 days
|
death of partitipant |
30 days
|
|
Need for re-exploration
大体时间：7-10
|
Need for re-exploration |
7-10
|
|
Early postoperative sepsis
大体时间：5-14 days
|
sepsis the develop in first week post surgery |
5-14 days
|
|
Duration of hospital stay
大体时间：10-21
|
Duration of hospital stay |
10-21
|
|
Time to first bowel movement
大体时间：3-10 days
|
the time consumed post surgery till neonate pass stool |
3-10 days
|
|
Time to remove nasogastric tube
大体时间：3-7 days
|
the time pass post surgery till nasogastric tube removed |
3-7 days
|
|
Stoma-related complications (Bishop-Koop group)
大体时间：5-90 days
|
the complication related to stoma that could occur in patients where bishop koop procedure was done |
5-90 days
|
合作者和调查者
调查人员
- 首席研究员：Ahmed Maher Khalil, lecturer of pediatric surgery、Alexandria University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 0307862
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
- Age
- Sex
- type of intestinal atresia
- Technique done (primary anastomosis with\without tapering vs Bishop Koop)
- Operative time
- Post-operative period
IPD 共享时间框架
January 2026- January 2028
IPD 共享支持信息类型
- 研究方案
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