A clinical study comparison between two groups of intestinal tract cleansing agents for colon capsule endoscopy based on the colonoscopy as a golden standard, and usefulness of interpretation support by clinical engineering technologist.

UMIN ID: UMIN000029398

Registered date:03/10/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: suspect of colorectal cancer
• Date of first enrollment: 2017/06/05
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

1) The method of intestinal tract cleansing; 2 days before the test, take 2 aperient tablets. The day before, take 190 ml of intestinal cleansing agent. The day of testing, take 1L of intestinal cleansing agent and 500 ml of water before swallowing the capsule. And also, on the day, until the release of the capsule is confirmed or until 15:30, every hour or every hour and half, intestinal tract cleansing drugs are orally administered or intravenous injections of intestinal peristalsis promotion drugs are carried out.
2) The method of intestinal tract cleansing; 2 days before the test, take 2 aperient tablets. The day before, take 1510 ml of intestinal cleansing agent. The day of testing, after swallowing the capsule, until the release of the capsule is confirmed, every hour or every two hours, intestinal tract cleansing drugs are orally administered or intravenous injections of intestinal peristalsis promotion drugs are carried out.
1) Image reading: First, the technician interprets the image, and then the doctor interprets and decides the diagnose it based on the information.
2) Image reading: The technician and the doctor interpret the image, respectively, and inquire about the result and decide the diagnosis.

Outcome(s)

• Primary Outcome: 1. Comparison between two groups of intestinal tract washing method. Acceptability of whole examination including questionnaire degree of intestinal tract, intestinal tract washing method (questionnaire) 2. Utility of colon capsule endoscope with colonoscopy as a golden standard Colon capsule endoscope total colon observation rate, colon lesion detection rate 3. Usefulness of interpretation support by clinical engineering technologist. Lesion detection rate, interpretation time by doctor 4. Other Clinical information (gender, age, height, body weight, reason for colon examination, etc.)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1. Person who has dysphagia disorder. 2. Person who have a history of allergic to drugs used in this study. 3. A woman who is pregnant or suspected to be pregnant. 4. Person who will undergo MRI within 2 weeks after colon capsule endoscopy. 5. Person who have a history of abdominal surgery, and there is a possibility of adhesion. 6. Person with present or past history of small and large bowel obstruction. 7. Person who suspicious of having colorectal advanced carcinoma by tumor markers or symptoms. 8. Person inappropriate for this study by other reasons judged by investigators.

Related Information

• Primary Sponsor: Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
• Source(s) of Monetary Support: Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital