The Randomized Controlled Trial of Coca-cola's Clinical Effects on Gastric Phytobezoars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 492
- 试验地点
- 1
- 主要终点
- Medical expense
研究概览
简要总结
Consecutive patients suffering from gastric phytobezoars were divided into 3 groups (Group 1, Group 2 and Group 3) according to the phytobezoars' formation time and each group was further subdivided into control and intervention group according to whether Coca-Cola was admitted. All patients in intervention group dieted Coca-Cola whereas patients in control group refused to drink Coca-Cola and had willing to receive the emergently gastric fragmentation.
详细描述
Consecutive patients were enrolled and were divided into Group 1(the formation time of phytobezoars was less than 7 days), Group 2(the formation time of phytobezoars was from 7 days to 14 days) and Group 3 (the formation time of phytobezoars was more than 14 days) according to the formation time of phytobezoars and each group was subdivided into control group (who refused to diet Coca-Cola and chose emergent fragmentation with gastroscopy) and intervention Group (who had a willing to diet Coca-Cola) from 1st Jan, 2017 to 1st Dec 2021. The current protocol was approved by the Medical Ethics Committee of the Affiliated Hospital of Qingdao University (QYFYWZLL 26293). The patients in intervention group all dieted Coca-Cola to treat gastric phytobezoars, 250ml-500ml/2 h till to sleeping time according to personal health conditions and life habits. Pay more attention to the stools and assess if the bezoars had excreted. The Coca-Cola dieting period of intervention group 1 was 3 days, intervention group 2 was 5 days and intervention group 3 was 7 days. The patients would go through an endoscopy once the Coca-Cola dieting therapy was over. The patients who chose emergently endoscopic fragmentation was enrolled in control Group. All patients endorsed the digital informed consent and bring the medical records before endoscopy. Statistical analysis was performed with SPSS version 22(IBM, Inc. Armonk, NY, USA). ANOVA or independent samples t-test was used for analysis of continuous variables. P < 0.05 was taken as statistical meaning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor don't know which group the patient is in.
入排标准
- 年龄范围
- 12 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed by abdominal CT or gastroscope;
- •years older than 12;
- •no contraindications;
- •have willingness to diet Caco-cola to treat gastric bezoars;
- •choose the emergent endoscopy whose bezoar formation time are more than 2 weeks;
排除标准
- •Gastroscopy contraindications;
- •choose the emergent endoscopy whose bezoar formation time are shorter than 2 weeks;
- •years younger than 12 years;
结局指标
主要结局
Medical expense
时间窗: up to 48 months
The medical expense of each patient was added together and compared among the groups
Operation time
时间窗: up to 48 months
The operation time of each patient was recorded and compared among the groups
Gastric ulcer rate
时间窗: up to 48 months
All the patients will go through a repeated endoscopy to ascertain if there was ulcers located in the stomach and record the findings
Dissolution rate
时间窗: up to 48 months
All the patients will go through a repeated endoscopy to ascertain if the phytobezoars has disappeared or shrinked and record the findings
次要结局
未报告次要终点
研究者
zhanglingyun,MD
Principal Investigator
The Affiliated Hospital of Qingdao University
