PEG Vs RIG: Percutaneous Endoscopic Gastrostomy Versus Radiologically Inserted Gastrostomy in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Complication rate
研究概览
简要总结
A gastrostomy is a feeding tube that communicates from the skin directly into the stomach. It is a device frequently used in children that have feeding difficulties or are unable to maintain normal growth via oral feeds. The same device may be inserted in two ways: the percutaneous endoscopic method (PEG) which is guided by the use of an endoscope (flexible camera), or the radiologically inserted method (RIG) which is guided by the use of X-ray imaging. Both methods of insertion have been used in children for more than 20 years, but it is not clear which is the best method. Both methods are associated with complications, including injury to other abdominal organs and leakage leading to sepsis. There are no randomised controlled trials comparing the two techniques.
We aim to compare the outcome of both methods of gastrostomy insertion in children, with emphasis on the complication rates. We have devised a complication score with weightage assigned to each complication according to its severity.
A randomised controlled trial will be performed in children requiring a gastrostomy, 100 per group. The primary outcome will be the overall total complication rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any child referred for gastrostomy insertion
排除标准
- •the child has gastro-esophageal reflux and is being considered for anti-reflux surgery
- •previous gastrostomy or fundoplication
- •previous extensive abdominal surgery
- •the child requires a concomitant major procedure on the gut or other intra- abdominal organs
结局指标
主要结局
Complication rate
时间窗: 3 years
The primary end point of the study will be the total number of complications (major and minor).
次要结局
- 1. major complication rate : complications requiring surgery(3 years)
- 2. minor complication rate : complications not requiring surgery(3 years)
- 3.complication score(3 years)
- 4.technical failure(3 yaers)
- 5.difficulty of procedure(3 years)
- 6.cost of hospital treatment(3 years)
- 7.mortality(3 years)
- 8.cause of death(3 years)