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Water Infusion and Carbon Dioxide Insufflation Versus Air Insufflation Versus Air Insufflation Techniques in Screening Colonoscopies in the United States: A Comparative Study Evaluating Safety, Efficacy and Adenoma Detection Rate (ADR)


Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Screening Colonoscopy

Thank you

Trial Information

Water Infusion and Carbon Dioxide Insufflation Versus Air Insufflation Versus Air Insufflation Techniques in Screening Colonoscopies in the United States: A Comparative Study Evaluating Safety, Efficacy and Adenoma Detection Rate (ADR)


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Outcome Measure:

Adenoma Detection Rate, proximal colon and total

Outcome Description:

The number of adenomas detected in proximal colon and total number of adenomas detected during the procedure will be compared between the three methods

Outcome Time Frame:

Day 1, At time of colonoscopy

Safety Issue:

No

Principal Investigator

Kendrick Che, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loma Linda University Medical Center

Authority:

United States: Institutional Review Board

Study ID:

5130003

NCT ID:

NCT01782014

Start Date:

February 2013

Completion Date:

January 2015

Related Keywords:

  • Screening Colonoscopy
  • Screening colonoscopy
  • Water method
  • Carbon dioxide method
  • Air method
  • Water versus carbon dioxide versus air insufflation colonoscopy
  • Adenoma Detection Rate
  • Pain Scores in colonoscopy
  • Adenoma

Name

Location

Loma Linda University Medical CenterLoma Linda, California  92354