Screening Colonoscopy
Conditions
Keywords
Screening colonoscopy, Water method, Carbon dioxide method, Air method, Water versus carbon dioxide versus air insufflation colonoscopy, Adenoma Detection Rate, Pain Scores in colonoscopy
Brief summary
The purpose of this study is to determine which of the methods of colonoscopy viz. water insufflation or air insufflation or carbon dioxide insufflation is better in detecting the adenomas in colon and also which of these methods is best tolerated by patients. Hypothesis: the investigators hypothesize that in patients undergoing first time screening colonoscopy a higher Adenoma Detection Rate will be found in the proximal colon in the group randomized to the water method compared to those randomized to the air or CO2 insufflation methods
Detailed description
Significance: ADR is an independent predictor of risk of post screening colonoscopy colon cancer. A simple method solely controlled by the colonoscopist that enhances proximal ADR holds the promise of rectifying some of the unresolved shortcomings of screening colonoscopy in failing to reduce the occurrence of post screening incident cancers in the proximal colon and the associated cancer mortality. Hypotheses & Specific Aims: Primary Hypothesis: In patients undergoing first time screening a higher ADR will be found in the proximal colon in those randomized to the water method compared to those randomized to the air method or CO2 method. Secondary Hypotheses: The examination method but not co-variables, procedure-related or patient-centered outcomes, is an independent predictor of proximal colon ADR. Specific Aims: This is a prospective, randomized, single-blinded controlled study to compare the study (water) and control 1 (air) method and control 2 (CO2 method) to aid insertion of the colonoscope. The proximal colon ADR, total ADR, co-variables, procedure-related and patient-centered outcomes and adverse event during and within 30 days of colonoscopy will be recorded and compared between the study and control methods.
Interventions
PROCEDUREcolonoscopy
colonoscopy using different methods of insufflation
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Asymptomatic patients with average risk for colorectal cancer, who are scheduled for first-time screening colonoscopy, will be enrolled.
Exclusion criteria
* decline to be randomized * unable to give consent * non-screening (surveillance or diagnostic) colonoscopy * current participation in other colonoscopy studies * a medical condition that could increase the risk associated with colonoscopy * pregnancy * those with a known family history of polyposis syndromes or a family history of colon cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Detection Rate, proximal colon and total | Day 1, At time of colonoscopy | The number of adenomas detected in proximal colon and total number of adenomas detected during the procedure will be compared between the three methods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | during and immediately after colonoscopy on day 1 | Visual Analog Scales will be used to calculate the pain scores based on the discomfort/pain experienced by the patient |
| Sedation requirements | Collected at Day 1, during the procedure | The amount of sedation required to complete the patient's colonoscopy. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient overall satisfaction score | immediately after colonoscopy on day 1 | patient satisfaction will be scored on a Visual Analog Scale |
Countries
United States
Outcome results
None listed