MCE for Gastric Examination in Obese People
- Conditions
- Obesity
- Interventions
- Device: MCE
- Registration Number
- NCT05909124
- Lead Sponsor
- Changhai Hospital
- Brief Summary
This retrospective study aimed to evaluate the feasibility and safety of MCE for the detection of gastric disease in obese people.
- Detailed Description
In this study, we evaluated the feasibility and safety of MCE for the detection of gastric disease in obese people by comparing the results of MCE between healthy weight people (18.5≤BMI\<25) and obese people (BMI≥30). The observation index included mucosal visualization, gastric transit time, cleanliness of the stomach, detection of lesions and safety evaluation.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 18.5≤BMI<25 or BMI≥30
- underwent gastric examination;
- At least 18 years old；
- Be able to provide informed consent.
- With swallowing obstruction or disorders;
- With known or suspected gastrointestinal obstruction, stenosis and fistula;
- Have no conditions for surgery or refuse to undergo any abdominal surgery;
- Be allergic to or have other known contraindication or intolerance to the drug used in the study;
- With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies;
- Women during pregnancy;
- Currently enrolled in another clinical trial of a drug or device;
- Other conditions determined by the investigator to be inappropriate for enrollment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description healthy weight people (18.5≤BMI<25) MCE 18.5≤BMI\<25 obese people (BMI≥30) MCE BMI≥30
- Primary Outcome Measures
Name Time Method the degree of gastric mucosal visualization 2 weeks The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, ≥90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, \<70% of the gastric mucosa can be observed.
- Secondary Outcome Measures
Name Time Method the cleanliness of the stomach 2 weeks The criteria for judging the cleanliness of the stomach are: excellent : no adhesive mucus and foam, clear field of view; good : a small amount of mucus and foam, but the field of view is not blurred and does not affect the integrity of the examination; average : medium amount of mucus and foam, the field of view is more blurred and affects the integrity of the examination; poor : a large amount of mucus and foam, the field of view is blurred and affects the integrity of the examination.
Gastric distention 2 weeks Assess condition of gastric distention. The criteria for judging gastric distention is: excellent, no obvious gastric folds; good, moderate distance between gastric folds, without folding; fair, short distance between gastric folds, with small amount of folding; poor, no obvious distance between gastric folds, with large amount of folding
Stomach transmit time 2 weeks The time of the first stomach image, the first small intestine image and the last image taken by capsule endoscopy were recorded. Stomach transmit time: time of first small intestine image minus time of first stomach image.
Incidence of adverse events 2 weeks The rates of adverse events such as asphyxia by capsule aspiration, swallow disorder, retention, technical failure, and procedural adverse events were recorded.
Small bowel transmit time 2 weeks The time of the first large intestine image minus the time of the first small intestine image.
Trial Locations
- Locations (1)
Changhai Hospital
🇨🇳Shanghai, Shanghai, China