Bowel Preparation, Magnetically Controlled Capsule Endoscopy
Conditions
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.
Interventions
DRUGPolyethylene Glycol Electrolytes Powder (II)
Polyethylene Glycol Electrolytes Powder (II) was used for bowel preparation.
OTHERLow residue diet
Low residue diet 1 day before the test, fasting from 20:00 pm.
OTHERNormal diet
Normal diet 1 day before the test, fasting from 20:00 pm.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years, male or female 2. 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
1. People who are ineligible for surgery or refuse to undergo any abdominal surgery (once the capsule is retained it cannot be removed surgically); 2. Known or suspected gastrointestinal obstruction, stenosis, and fistula; 3. People with implanted cardiac pacemakers or other electronic devices; 4. People with swallowing disorders; 5. Women during pregnancy; 6. People who are unable or unwilling to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image quality of small intestine | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of completion of inspections | 1 day (Upon completion of the examination) | The examination is considered complete when the capsule reaches the cecum. |
| Small intestine transit time | 1 day (Upon completion of the examination) | Time taken for the capsule to pass through the entire small intestine to reach the cecum. |
| Lesion detection rate | 1 day (Upon completion of the examination) | 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. |
| Patient tolerance | 1 day (Upon completion of the examination) | Evaluated by completing a case report form based on the patient's personal feelings during the bowel preparation process. |
| Rate of adverse events | 1 day (Upon completion of the examination) | Patients were observed for adverse events (nausea, vomiting, bloating, etc.) and for capsule retention after examination. |
Countries
China
Contacts
Primary ContactFeixue Chen, Ph.D
Outcome results
None listed