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

This study is currently recruiting participants.
Verified February 2013 by Loma Linda University
Sponsor:
Information provided by (Responsible Party):
Kendrick Che, DO, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01782014
First received: January 27, 2013
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Screening Colonoscopy
Procedure: colonoscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Adenoma Detection Rate, proximal colon and total [ Time Frame: Day 1, At time of colonoscopy ] [ Designated as safety issue: No ]
    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:
  • Pain scores [ Time Frame: during and immediately after colonoscopy on day 1 ] [ Designated as safety issue: Yes ]
    Visual Analog Scales will be used to calculate the pain scores based on the discomfort/pain experienced by the patient

  • Sedation requirements [ Time Frame: Collected at Day 1, during the procedure ] [ Designated as safety issue: No ]
    The amount of sedation required to complete the patient's colonoscopy.


Other Outcome Measures:
  • Patient overall satisfaction score [ Time Frame: immediately after colonoscopy on day 1 ] [ Designated as safety issue: No ]
    patient satisfaction will be scored on a Visual Analog Scale


Estimated Enrollment: 450
Study Start Date: February 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Water Insufflation
Colonoscopy using water insufflation
Procedure: colonoscopy
colonoscopy using different methods of insufflation
Active Comparator: Carbon dioxide insufflation
Colonoscopy using carbon dioxide insufflation
Procedure: colonoscopy
colonoscopy using different methods of insufflation
Active Comparator: Air insufflation
Colonoscopy using air insufflation
Procedure: colonoscopy
colonoscopy using different methods of insufflation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782014

Contacts
Contact: Arvind K Mathur, MD 909-558-4000 ext 44911 amathur@llu.edu
Contact: Donald Portocarrero, DO 909-558-4000 ext 44911 dportocarrero@llu.edu

Locations
United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Arvind K Mathur, MD    909-558-4000 ext 44911    amathur@llu.edu   
Contact: Donald Portocarrero, DO    909-558-400 ext 44911    dportocarrero@llu.edu   
Sub-Investigator: Arvind K Mathur, MD         
Sub-Investigator: Robert Basseri, MD         
Sub-Investigator: Donald Portocarrero, DO         
Principal Investigator: Kendrick Che, DO         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Kendrick Che, DO    909-558-4000 ext 44911    kche@llu.edu   
Contact: Donald Portocarrero, DO    909-558-400 ext 44911    dportocarrero@llu.edu   
Sub-Investigator: Arvind K Mathur, MD         
Sub-Investigator: Robert Basseri, MD         
Sub-Investigator: Donald Portocarrero, DO         
Principal Investigator: Kendrick Che, DO         
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Kendrick Che, DO Loma Linda University Medical Center
Study Chair: Terrence Lewis, MD Loma Linda University Medical Center
Study Chair: Michael Walter, MD Loma Linda University Medical Center
  More Information

Additional Information:
Publications:

Responsible Party: Kendrick Che, DO, Principle Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT01782014     History of Changes
Other Study ID Numbers: 5130003, LLUMCGI2013
Study First Received: January 27, 2013
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Screening colonoscopy
Water method
Carbon dioxide method
Air method
Water versus carbon dioxide versus air insufflation colonoscopy
Adenoma Detection Rate
Pain Scores in colonoscopy

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014