Comparison of Adenoma Detection Rate Among Water, Carbon Dioxide and Air Methods of Minimal Sedation Colonoscopy
- Conditions
- Screening Colonoscopy
- Interventions
- Procedure: colonoscopy
- Registration Number
- NCT01782014
- Lead Sponsor
- Loma Linda University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 450
- Asymptomatic patients with average risk for colorectal cancer, who are scheduled for first-time screening colonoscopy, will be enrolled.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Water Insufflation colonoscopy Colonoscopy using water insufflation Carbon dioxide insufflation colonoscopy Colonoscopy using carbon dioxide insufflation Air insufflation colonoscopy Colonoscopy using air insufflation
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States