Randomized Clinical Trial to Compare Air Versus Carbon Dioxide in Screening Unsedated Colonoscopy.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- duration of procedure
Study Overview
Brief Summary
Colonoscopy is currently most effective procedure used for detecting colon cancer especially in the early stages. Screening colonoscopies are performed in the symptom-free patients at risk of familial colon cancer. During colonoscopy air commonly used to insufflate the bowel may be retained after the procedure causing pain and discomfort to the patients. One of the methods used to reduce pain and discomfort is insufflation of carbon dioxide (CO2) instead of air during colonoscopy.
Aim of the study is evaluation of the use of carbon dioxide insufflation during colonoscopy.
Detailed Description
The study was conducted in 200 consecutive patients undergoing screening colonoscopies for the detection of early colon cancer. The examinations were performed with Olympus 165 colonoscopes by seven experienced endoscopists, each of whom performed alone about over 2000 colonoscopies. The patients were randomly assigned to Group I and II with either air or carbon dioxide insufflation. Both study groups were matched by sex, age, duration of the procedure, and BMI. The authors compared for the duration of the procedure, coecal intubation time, complication rate, pulse rates immediately after the procedure, 15 minutes after, and subjective pain evaluation on a Visual Analogue Scale.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age 50 yo and more
- •no previous large bowel operations
- •no previous colonoscopy
- •informed consent
Exclusion Criteria
- •previous colonoscopy
- •previous large bowel operations/ polypectomies
Outcomes
Primary Outcomes
duration of procedure
Time Frame: 1 hour
Time from introduction of a colonoscope to removal of the colonoscope.
Secondary Outcomes
- coecal intubation time(1 hour)
- pain immediately after the procedure(1 min)
- pain 15 minutes after colonoscopy(15 min)
- complication rate(24 hours)
Investigators
Radoslaw Pach
Assisstant Professor
Jagiellonian University