Comparison of Adenoma Detection Rate Among Water, Carbon Dioxide and Air Methods of Minimal Sedation Colonoscopy

Loma Linda University (LLU)

Status and phase: Terminated; Phase 3

Conditions: Screening Colonoscopy

Treatments: Procedure: colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01782014

5130003

LLUMCGI2013 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 3 patient groups

Water Insufflation

Experimental group

Description:

Colonoscopy using water insufflation

Treatment:

Procedure: colonoscopy

Carbon dioxide insufflation

Active Comparator group

Description:

Colonoscopy using carbon dioxide insufflation

Treatment:

Procedure: colonoscopy

Air insufflation

Active Comparator group

Description:

Colonoscopy using air insufflation

Treatment:

Procedure: colonoscopy