Does the Thickness of the Gastrostomy Affect the Incidence of Complications? A Prospective Randomized Single-Center Study in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Granuloma
研究概览
简要总结
The goal of this interventional study is to compare two different sizes of a gastrostomy tube in children and the incidence of complications three months postoperatively. The study is questionnare-based and both the family and health care personel will fill in the formula about complications at the re-visit when the tube is changed the first time at three months postoperatively. Complications requested are: granuloma, infection, pain, dislocation and leakage.
详细描述
Project plan Does gastrostomy tube thickness affect incidence of complications?
Hypothesis A 12 Fr gastrostomy tube is associated with fewer complications than a 14 Fr tube.
Aim To investigate if the rate of postoperative complications is reduced when a 12 Fr gastrostomy is used instead of a 14 Fr.
Overview Placement of a gastrostomy is indicated in children with long term need of enteral nutrition where oral intake is inadequate and there is at least a partially functioning digestive tract [1]. The operative procedure includes creation of a channel through the stomach- and abdominal wall with placement of a tube. The tube keeps the channel open and enables feeding of and medication to the patient. There are different ways of establishing a gastrostomy: laparoscopic, percutaneous, radiologically assisted and open techniques. Some researchers consider the laparoscopic approach to be the most preferable and safe option while others prefer the percutaneous or open technique [2,3,4,5].
In Sweden approximately 300-400 children (0-18 years) receive a gastrostomy yearly, and it is one of the most common inpatient care interventions in children. The majority of patients have an underlying neurological disease with multiple somatic and/or cognitive impairments. Other indications include failure to thrive, nausea during cancer treatment, metabolic disorders, and gastrointestinal failure [6].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for laparoscopic gastrostomy at Dep Pediatric Surgery Uppsala Akademiska University Hospital
排除标准
- •Any specific reasons to avoid one size or the other (children who are supposed to get mixed food or a special medication that can obstruate the tube will recieve a thicker tube)
结局指标
主要结局
Granuloma
时间窗: 3 months postoperatively
Leakage
时间窗: 3 months postoperatively
Infection
时间窗: 3 months postoperatively
Observed pain by caretakers/health care personel
时间窗: 3 months postoperatively
Dislocation
时间窗: 3 months postoperatively
次要结局
未报告次要终点
研究者
Therese Hössjer
Pediatric Surgeon, PhD-student
Uppsala University Hospital
