Patients indicated for small bowel capsule endoscopy for diagnostic evaluation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients undergoing small bowel capsule endoscopy 2. Aged 18 years or older at the time of obtaining informed consent 3. Able to take oral laxatives 4. Patients who have provided written informed consent of their own free will to participate in this clinical study
Exclusion criteria
Exclusion criteria: 1. Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2). 2. Patients with severe heart failure (NYHA Class III or IV). 3. Patients with hyponatremia (serum sodium < 136 mEq/L) or hypokalemia (serum potassium < 3.5 mEq/L). 4. Patients with a history of surgical resection of the gastrointestinal tract (excluding appendectomy). 5. Patients who show evidence of impaired gastrointestinal passage on transit studies, or who are suspected of having intestinal obstruction or perforation. 6. Patients with toxic megacolon. 7. Patients suspected of having an acute abdomen. 8. Patients with a history of hypersensitivity to any component of PicoPrep. 9. Patients receiving iron supplementation who, for clinical reasons, are unable to comply with the discontinuation required in this study (cessation at least 7 days before examination). 10. Any other patients deemed inappropriate for inclusion in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Image Quality Score of the Small Bowel Mucosa | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection of pathological findings (bleeding, ulcerations, or vascular abnormalities) Evaluation of adequacy of bowel cleansing(whether an image quality score of 2.25 or higher was achieved) Completion of small bowel capsule endoscopy to the cecum within the recording time Measurement of small bowel transit time | — |
Contacts
Kobe University Hospital