Coca-cola's Clinical Effects on Gastric Phytobezoars

Not Applicable

Completed

• Conditions: Bezoars
• Interventions: Other: dieting Coca-cola

• Registration Number: NCT05645263
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2022-11-22
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-01
• Last Update Submitted: 2022-12-01
• Study First Posted: 2022-12-09
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 492

Inclusion Criteria

• 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;

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Exclusion Criteria

• Gastroscopy contraindications;
• choose the emergent endoscopy whose bezoar formation time are shorter than 2 weeks;
• years younger than 12 years;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cola 3（7d）	dieting Coca-cola	The patients in intervention group 3 dieted Coca-cola to treat gastric phytobezoars, 250ml-500ml/2 h till to sleeping time according to the health conditions and life habits. Pay more attention to the stools and assess if the bezoars had excreted. The dieting Coca-cola period is 7 days. The patients will go through an endoscopy once the Coco-cola dieting therapy is over.
Cola 1（3d）	dieting Coca-cola	The patients in intervention group 1 dieted Coca-cola to treat gastric phytobezoars, 250ml-500ml/2 h till to sleeping time according to the health conditions and life habits. Pay more attention to the stools and assess if the bezoars had excreted. The dieting Coca-cola period is 3 days.The patients will go through an endoscopy once the Coca-cola dieting therapy is over.
Cola 2（5d）	dieting Coca-cola	The patients in intervention group 2 dieted Coca-cola to treat gastric phytobezoars, 250ml-500ml/2 h till to sleeping time according to the health conditions and life habits. Pay more attention to the stools and assess if the bezoars had excreted. The dieting Coca-cola period is 5 days. The patients will go through an endoscopy once the Coca-cola dieting therapy is over.

Primary Outcome Measures

Name	Time	Method
Medical expense	up to 48 months	The medical expense of each patient was added together and compared among the groups
Operation time	up to 48 months	The operation time of each patient was recorded and compared among the groups
Gastric ulcer rate	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	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

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China