Measurement of internal colonic pressure using a colonoscopy and development of a predictive model of defecation and stool form.

UMIN ID: UMIN000055605

Registered date:30/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients who will receive a colonoscopy.
• Date of first enrollment: 2024/10/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Measuring the internal colonic pressure with carbon dioxide injection through a colonoscope.

Outcome(s)

• Primary Outcome: Peak internal pressure values in the cecum, transverse colon, and rectum during carbon dioxide injection through a colonoscope.
• Secondary Outcome: Rate of increased internal colonic pressure by carbon dioxide injection. Relationship between abdominal discomfort or symptom and internal colonic pressure. Relationship between defecation frequency and internal colonic pressure. Relationship between Bristol stool form scale and internal colonic pressure.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: 1. History of colorectal surgery 2. Known inflammatory bowel disease 3. Known hereditary or non-hereditary polyposis syndrome 4. Known hereditary non-polyposis colorectal cancer (HNPCC) 5. Known severe diverticular segment which restricts colonoscopy 6. Unable to intake bowel preparation agent 7. Allergy for any drugs used during colonoscopy 8. Known colorectal adenoma, polyp, or cancer before the trial 9. Pregnancy 10. Breast-feeding 11. Lack of informed consent 12. Others

Related Information

• Primary Sponsor: International University of Health and Welfare
• Source(s) of Monetary Support: International University of Health and Welfare