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临床试验/NCT07300865
NCT07300865招募中不适用

Does the Thickness of the Gastrostomy Affect the Incidence of Complications? A Prospective Randomized Single-Center Study in Children

Therese Hössjer2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年11月20日最近更新:
适应症

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

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

发起方
Therese Hössjer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Therese Hössjer

Pediatric Surgeon, PhD-student

Uppsala University Hospital

研究点 (2)

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