An analysis of the function of lower gastrointestinal tract using Endoscopic pressure study integrated system (EPSIS)

UMIN ID: UMIN000044774

Registered date:06/07/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: functional gastrointestinal disorders
• Date of first enrollment: 2021/07/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Carbon dioxide insufflation into the intestinal tract during colonoscopy for subjects undergoing colonoscopy (FGID patients)
Carbon dioxide insufflation into the intestinal tract during colonoscopy for subjects undergoing colonoscopy (other patients)

Outcome(s)

• Primary Outcome: At the time of maximum intestinal distension Intra-intestinal pressure (IIP) max Intra-intestinal pressure (IIP) max at the time of maximum intestinal distension Uphill pattern/flat pattern Intestinal pressure waveform slope Endoscopic findings at the time the maximum pressure was recorded Investigate trends in each section (small bowel, cecum to ascending colon, transverse colon, descending colon, sigmoid colon, rectum).
• Secondary Outcome: Association with factors outside the intestinal tract that may affect intestinal content Association with factors outside the intestinal tract that may affect the intestinal content: body size (height and weight BMI), history of abdominal surgery, inflammatory diseases of the abdomen, etc. Endoscopic findings: association with factors related to intestinal wall extension (e.g., scarring of the intestine) Intra-intestinal pressure changes when intestinal peristalsis is induced Changes in bowel pressure before and after administration of a test drug that has an effect on bowel peristalsis Changes in abdominal symptoms associated with pressurization (non-sedated patients) Assess the relationship between the degree of distress and the pressure at which distress was felt using the VAS scale

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients who are pregnant. Patients with serious underlying diseases (serious respiratory disease, cardiac failure, renal failure, hepatic failure). Patients who are considered ineligible by the investigator

Related Information

• Primary Sponsor: Showa University Koto Toyosu Hospital
• Source(s) of Monetary Support: Showa University Koto Toyosu Hospital