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Completed

NCT Number: NCT05645263

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

dieting Coca-cola

Other

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.

Primary outcomes

  1. Dissolution rate

    Time frame: 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

  2. Medical expense

    Time frame: up to 48 months

    The medical expense of each patient was added together and compared among the groups

  3. Operation time

    Time frame: up to 48 months

    The operation time of each patient was recorded and compared among the groups

  4. Gastric ulcer rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Dec 9, 2022
Registry last updated
Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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