Coca-cola's Clinical Effects on Gastric Phytobezoars

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

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.

Study Overview

• Status: Completed
• Conditions: Bezoars
• Intervention / Treatment: Other: dieting Coca-cola

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 Type: Interventional
• Enrollment (Actual): 492
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • The affiliated hospital of Qingdao university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cola 1（3d）; 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.	Other: dieting Coca-cola; The patients all dieted Coco-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 Coco-cola period of group A is 3 days, group B is 5 days and group C is 7 days.
Experimental: Cola 2（5d）; 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.	Other: dieting Coca-cola; The patients all dieted Coco-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 Coco-cola period of group A is 3 days, group B is 5 days and group C is 7 days.
Experimental: Cola 3（7d）; 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.	Other: dieting Coca-cola; The patients all dieted Coco-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 Coco-cola period of group A is 3 days, group B is 5 days and group C is 7 days.
No Intervention: Fragmentation 1; The patients who chose emergently endoscopic fragmentation was enrolled in control group 1. All patients endorsed the informed consent paper, no diet for at least 4 hours, no drink for 2 hours and bring the medical records before endoscopy and go on a mechanical fragmentation through gastroendoscopy
No Intervention: Fragmentation 2; The patients who chose emergently endoscopic fragmentation was enrolled in control group 2. All patients endorsed the informed consent paper, no diet for at least 4 hours, no drink for 2 hours and bring the medical records before endoscopy and go on a mechanical fragmentation through gastroendoscopy
No Intervention: Fragmentation 3; The patients who chose emergently endoscopic fragmentation was enrolled in controlled Group 3. All patients endorsed the informed consent paper, no diet for at least 4 hours, no drink for 2 hours and bring the medical records before endoscopy and go on a mechanical fragmentation through gastroendoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dissolution rate	All the patients will go through a repeated endoscopy to ascertain if the phytobezoars has disappeared or shrinked and record the findings	up to 48 months
Medical expense	The medical expense of each patient was added together and compared among the groups	up to 48 months
Operation time	The operation time of each patient was recorded and compared among the groups	up to 48 months
Gastric ulcer rate	All the patients will go through a repeated endoscopy to ascertain if there was ulcers located in the stomach and record the findings	up to 48 months

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Investigators: Study Chair: Yu Cao, PHD, The affiliated hospital of Qingdao university

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Estimate): December 9, 2022

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: RCT; lithotripsy; Gastroscopy; Bezoars; Cola
• Additional Relevant MeSH Terms: Wounds and Injuries; Foreign Bodies; Bezoars
• Other Study ID Numbers: zhanglingyunzhanglingyun

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There isn't a plan to make individual participant data available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No