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临床试验/NCT05645263
NCT05645263已完成不适用

The Randomized Controlled Trial of Coca-cola's Clinical Effects on Gastric Phytobezoars

The Affiliated Hospital of Qingdao University1 个研究点 分布在 1 个国家目标入组 492 人开始时间: 2017年1月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

zhanglingyun,MD

Principal Investigator

The Affiliated Hospital of Qingdao University

研究点 (1)

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