BezoarsNCT05645263
Coca-cola's Clinical Effects on Gastric Phytobezoars
A study testing dieting Coca-cola in people with Bezoars, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Bezoars
- What is being tested?
- dieting Coca-cola
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- Gastroscopy contraindications;
- choose the emergent endoscopy whose bezoar formation time are shorter than 2 weeks;
- years younger than 12 years;
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
About this study
Official title: 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.
Read the 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.
- Conditions
- Bezoars
- Being tested
- dieting Coca-cola
- Keywords
- RCT, Bezoars, Cola, lithotripsy, Gastroscopy
- Medical subject headings
- Bezoars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dieting Coca-colaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cola 1（3d） | Experimental | 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. Receives: Other: dieting Coca-cola |
| Cola 2（5d） | Experimental | 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. Receives: Other: dieting Coca-cola |
| Cola 3（7d） | Experimental | 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. Receives: Other: dieting Coca-cola |
| Fragmentation 1 | No intervention | 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 |
| Fragmentation 2 | No intervention | 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 |
| Fragmentation 3 | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Dissolution rate
All the patients will go through a repeated endoscopy to ascertain if the phytobezoars has disappeared or shrinked and record the findings
Measured: up to 48 months
Medical expense
The medical expense of each patient was added together and compared among the groups
Measured: up to 48 months
Operation time
The operation time of each patient was recorded and compared among the groups
Measured: 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
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Jan 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BezoarsStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhanglingyun，MD, The Affiliated Hospital of Qingdao University
- Investigators
- Yu Cao, PHD, Study chair, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645263
- Sponsor's protocol ID
- zhanglingyunzhanglingyun
- Status last verified
- Dec 2022
- First submitted
- 22 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There isn't a plan to make individual participant data available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Controlled Trial of Coca-cola's Clinical Effects on Gastric Phytobezoars
- ClinicalTrials.gov ID
- NCT05645263
- Acronym / sponsor ID
- zhanglingyunzhanglingyun
- Conditions
- Bezoars
- Keywords
- RCT, Bezoars, Cola, lithotripsy, Gastroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cola 1（3d） | Experimental | Other: dieting Coca-colaThe 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） | Experimental | Other: dieting Coca-colaThe 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. |
| Cola 3（7d） | Experimental | Other: dieting Coca-colaThe 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. |
| Fragmentation 1 | No intervention | –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 |
| Fragmentation 2 | No intervention | –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 |
| Fragmentation 3 | No intervention | –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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (3 listed)
- Gastroscopy contraindications;
- choose the emergent endoscopy whose bezoar formation time are shorter than 2 weeks;
- years younger than 12 years;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dieting Coca-colaThe 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. | Other | Cola 1（3d）, Cola 2（5d）, Cola 3（7d） |
Primary outcome
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
Medical expense
Time frame: up to 48 months
The medical expense of each patient was added together and compared among the groups
Operation time
Time frame: up to 48 months
The operation time of each patient was recorded and compared among the groups
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No. There isn't a plan to make individual participant data available to other researchers
Related trials for Bezoars
Recruiting
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Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Cao, PHD study chair
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dieting Coca-cola in people with Bezoars, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dissolution rate (time frame: up to 48 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.