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

Screening Colonoscopy Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01782014
• Other study ID #: 5130003
• Secondary ID: LLUMCGI2013
• Status: Terminated
• Phase: Phase 3
• First received: January 27, 2013
• Last updated: January 28, 2016
• Start date: February 2013
• Est. completion date: March 2015

Study information

• Verified date: September 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Terminated
• Enrollment: 450
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Screening Colonoscopy

Intervention

Procedure:
• colonoscopy
colonoscopy using different methods of insufflation

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. doi: 10.1016/j.gie.2008.08.014. — View Citation

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 w — View Citation

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. doi: 10.1055/s-0030-1256407. Epub 2011 May 24. — View Citation

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 vete — View Citation

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. — View Citation

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. — View Citation

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 inser — View Citation

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. — View Citation

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. doi: 10.1111/j.1445-2197.2008.04683.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient overall satisfaction score	patient satisfaction will be scored on a Visual Analog Scale	immediately after colonoscopy on day 1	No
Primary	Adenoma Detection Rate, proximal colon and total	The number of adenomas detected in proximal colon and total number of adenomas detected during the procedure will be compared between the three methods	Day 1, At time of colonoscopy	No
Secondary	Pain scores	Visual Analog Scales will be used to calculate the pain scores based on the discomfort/pain experienced by the patient	during and immediately after colonoscopy on day 1	Yes
Secondary	Sedation requirements	The amount of sedation required to complete the patient's colonoscopy.	Collected at Day 1, during the procedure	No

External Links

•   link to Loma Linda University Research website