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Coca-cola's Clinical Effects on Gastric Phytobezoars

NCT ID: NCT05645263

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

492 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Bezoars

Keywords

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RCT Bezoars Cola lithotripsy Gastroscopy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

All patients were divided into 3 groups according to bezoar formation time combined with the willing of the patients. Patients whose phytobezoar formation time was less than a week in Group 1 , phytobezoar formation time between 1week and 2 weeks in Group2 , phytobezoar formation time longer than 2 weeks in Group 3. Every group was subdivided into intervention and control group according to whether Coco-cola was dieted.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessor don't know which group the patient is in.

Study Groups

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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.

Group Type EXPERIMENTAL

dieting Coca-cola

Intervention Type 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.

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.

Group Type EXPERIMENTAL

dieting Coca-cola

Intervention Type 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.

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.

Group Type EXPERIMENTAL

dieting Coca-cola

Intervention Type 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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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;
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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zhanglingyun，MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu Cao, PHD

Role: STUDY_CHAIR

The Affiliated Hospital of Qingdao University

Locations

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The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Countries

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China

Other Identifiers

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zhanglingyunzhanglingyun

Identifier Type: -

Identifier Source: org_study_id