Clinical trial NCT05645263: Coca-cola's Clinical Effects on Gastric Phytobezoars
Official title: The Randomized Controlled Trial of Coca-cola's Clinical Effects on Gastric Phytobezoars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bezoars
Keywords: RCT
Bezoars
Cola
lithotripsy
Gastroscopy
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 492
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Dissolution rate
timeFrame: up to 48 months
measure: Medical expense
timeFrame: up to 48 months
measure: Operation time
timeFrame: up to 48 months
measure: Gastric ulcer rate
timeFrame: up to 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Yu Cao, PHD
role: STUDY_CHAIR
References: