An interventional study of Polyethylene Glycol Electrolytes Powder (II) and Low residue diet in Magnetically Controlled Capsule Endoscopy and Bowel Preparation, sponsored by Qilu Hospital of Shandong University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Diagnostic
The study aimed to compare the effects of bowel preparation methods of a normal diet for 1 day, a low residue diet for 1 day, and laxative bowel cleaning on the image quality of magnetically controlled capsule endoscopy, and to assess the rate of completion of the examination, small intestine transit time, lesion detection, patient tolerance, and safety of the three regimens.
Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.
Counted across the registry records on this site, refreshed daily.
(1) Unexplained gastrointestinal bleeding; (2) Unexplained iron deficiency anaemia; (3) Suspected Crohn's disease or monitoring and directing treatment for Crohn's disease; (4) Suspected small bowel tumour; (5) Monitoring the development of small bowel polyposis syndrome; (6) Suspected or difficult to control malabsorption syndromes (e.g., celiac disease, etc.); (7) Detection of NSAID-associated small bowel mucosal damage; (8) Those with a clinical need to exclude small bowel disease.
Exclusion Criteria:
Normal diet 1 day before the test, fasting and laxatives from 20:00 pm. The laxatives, Polyethylene Glycol Electrolytes Powder (II), should be prepared as a solution and taken as 2000 ml the night before the test and 1000 ml the following morning, within 2 hours and 1 hour, respectively.
Drug: Polyethylene Glycol Electrolytes Powder (II)
Low residue diet 1 day before the test, fasting from 20:00 pm.
Other: Low residue diet
Normal diet 1 day before the test, fasting from 20:00 pm.
Other: Normal diet
Polyethylene Glycol Electrolytes Powder (II) was used for bowel preparation.
Also known as: laxatives for bowel preparation
Low residue diet 1 day before the test, fasting from 20:00 pm.
Normal diet 1 day before the test, fasting from 20:00 pm.
Image quality of small intestine
The small bowel cleanliness score and the small bowel bubble volume score were used to evaluate image quality.
Time frame: 1 day (Upon completion of the examination)
Rate of completion of inspections
The examination is considered complete when the capsule reaches the cecum.
Time frame: 1 day (Upon completion of the examination)
Small intestine transit time
Time taken for the capsule to pass through the entire small intestine to reach the cecum.
Time frame: 1 day (Upon completion of the examination)
Lesion detection rate
Proportion of cases with lesions relevant to the indication for examination or capable of explaining the patient's complaints or symptoms to the total number of cases.
Time frame: 1 day (Upon completion of the examination)
Patient tolerance
Evaluated by completing a case report form based on the patient's personal feelings during the bowel preparation process.
Time frame: 1 day (Upon completion of the examination)
Rate of adverse events
Patients were observed for adverse events (nausea, vomiting, bloating, etc.) and for capsule retention after examination.
Time frame: 1 day (Upon completion of the examination)
Plan to share: No
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Qilu Hospital of Shandong University