Evaluation of Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy: a Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Polyethylene Glycol Electrolytes Powder (II)
- Conditions
- Magnetically Controlled Capsule Endoscopy
- Sponsor
- Qilu Hospital of Shandong University
- Enrollment
- 375
- Locations
- 1
- Primary Endpoint
- Image quality of small intestine
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years, male or female
- •One of the following examination indications:
- •(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
- •People who are ineligible for surgery or refuse to undergo any abdominal surgery (once the capsule is retained it cannot be removed surgically);
- •Known or suspected gastrointestinal obstruction, stenosis, and fistula;
- •People with implanted cardiac pacemakers or other electronic devices;
- •People with swallowing disorders;
- •Women during pregnancy;
- •People who are unable or unwilling to provide informed consent.
Arms & Interventions
Laxatives arm
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.
Intervention: Polyethylene Glycol Electrolytes Powder (II)
Low residue diet arm
Low residue diet 1 day before the test, fasting from 20:00 pm.
Intervention: Low residue diet
Normal diet arm
Normal diet 1 day before the test, fasting from 20:00 pm.
Intervention: Normal diet
Outcomes
Primary Outcomes
Image quality of small intestine
Time Frame: 1 day (Upon completion of the examination)
The small bowel cleanliness score and the small bowel bubble volume score were used to evaluate image quality.
Secondary Outcomes
- Rate of completion of inspections(1 day (Upon completion of the examination))
- Small intestine transit time(1 day (Upon completion of the examination))
- Patient tolerance(1 day (Upon completion of the examination))
- Rate of adverse events(1 day (Upon completion of the examination))
- Lesion detection rate(1 day (Upon completion of the examination))