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

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:

MedlinePlus related topics: Colonoscopy Drinking Water

Drug Information available for: Carbon dioxide

U.S. FDA Resources

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:

link to Loma Linda University Research website This link exits the ClinicalTrials.gov site

Publications:

Leung FW, Aharonian HS, Leung JW, Guth PH, Jackson G. Impact of a novel water method on scheduled unsedated colonoscopy in U.S. veterans. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):546-50.

Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. Epub 2009 Jun 24.

Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. Epub 2010 Jul 8.

Leung JW, Do LD, Siao-Salera RM, Ngo C, Parikh DA, Mann SK, Leung FW. Retrospective analysis showing the water method increased adenoma detection rate - a hypothesis generating observation. J Interv Gastroenterol. 2011 Jan;1(1):3-7.

Leung FW, Leung JW, Siao-Salera RM, Mann SK. The water method significantly enhances proximal diminutive adenoma detection rate in unsedated patients. J Interv Gastroenterol. 2011 Jan;1(1):8-13.

Leung FW, Leung JW, Siao-Salera RM, Mann SK, Jackson G. The water method significantly enhances detection of diminutive lesions (adenoma and hyperplastic polyp combined) in the proximal colon in screening colonoscopy - data derived from two RCT in US veterans. J Interv Gastroenterol. 2011 Apr;1(2):48-52. PubMed PMID: 21776425; PubMed Central PMCID: PMC3136853.

Stevenson GW, Wilson JA, Wilkinson J, Norman G, Goodacre RL. Pain following colonoscopy: elimination with carbon dioxide. Gastrointest Endosc. 1992 Sep-Oct;38(5):564-7.

Wong JC, Yau KK, Cheung HY, Wong DC, Chung CC, Li MK. Towards painless colonoscopy: a randomized controlled trial on carbon dioxide-insufflating colonoscopy. ANZ J Surg. 2008 Oct;78(10):871-4.

Leung FW, Leung JW, Mann SK, Friedland S, Ramirez FC. The water method significantly enhances patient-centered outcomes in sedated and unsedated colonoscopy. Endoscopy. 2011 Sep;43(9):816-21. Epub 2011 May 24.

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 May 21, 2013