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

Primary Purpose

Screening Colonoscopy

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
colonoscopy
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Screening Colonoscopy focused on measuring Screening colonoscopy, Water method, Carbon dioxide method, Air method, Water versus carbon dioxide versus air insufflation colonoscopy, Adenoma Detection Rate, Pain Scores in colonoscopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Loma Linda University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Water Insufflation

Carbon dioxide insufflation

Air insufflation

Arm Description

Colonoscopy using water insufflation

Colonoscopy using carbon dioxide insufflation

Colonoscopy using air insufflation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain scores
Visual Analog Scales will be used to calculate the pain scores based on the discomfort/pain experienced by the patient
Sedation requirements
The amount of sedation required to complete the patient's colonoscopy.

Full Information

First Posted
January 27, 2013
Last Updated
January 28, 2016
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT01782014
Brief Title
Comparison of Adenoma Detection Rate Among Water, Carbon Dioxide and Air Methods of Minimal Sedation Colonoscopy
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Screening Colonoscopy
Keywords
Screening colonoscopy, Water method, Carbon dioxide method, Air method, Water versus carbon dioxide versus air insufflation colonoscopy, Adenoma Detection Rate, Pain Scores in colonoscopy

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Water Insufflation
Arm Type
Experimental
Arm Description
Colonoscopy using water insufflation
Arm Title
Carbon dioxide insufflation
Arm Type
Active Comparator
Arm Description
Colonoscopy using carbon dioxide insufflation
Arm Title
Air insufflation
Arm Type
Active Comparator
Arm Description
Colonoscopy using air insufflation
Intervention Type
Procedure
Intervention Name(s)
colonoscopy
Intervention Description
colonoscopy using different methods of insufflation
Primary Outcome Measure Information:
Title
Adenoma Detection Rate, proximal colon and total
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
Time Frame
Day 1, At time of colonoscopy
Secondary Outcome Measure Information:
Title
Pain scores
Description
Visual Analog Scales will be used to calculate the pain scores based on the discomfort/pain experienced by the patient
Time Frame
during and immediately after colonoscopy on day 1
Title
Sedation requirements
Description
The amount of sedation required to complete the patient's colonoscopy.
Time Frame
Collected at Day 1, during the procedure
Other Pre-specified Outcome Measures:
Title
Patient overall satisfaction score
Description
patient satisfaction will be scored on a Visual Analog Scale
Time Frame
immediately after colonoscopy on day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kendrick Che, DO
Organizational Affiliation
Loma Linda University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Terrence Lewis, MD
Organizational Affiliation
Loma Linda University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael Walter, MD
Organizational Affiliation
Loma Linda University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19231497
Citation
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.
Results Reference
result
PubMed Identifier
19555938
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 insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.
Results Reference
result
PubMed Identifier
20619405
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 water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8.
Results Reference
result
PubMed Identifier
21686105
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. doi: 10.4161/jig.1.1.14585.
Results Reference
result
PubMed Identifier
21686106
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. doi: 10.4161/jig.1.1.14587.
Results Reference
result
PubMed Identifier
21776425
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 veterans. J Interv Gastroenterol. 2011 Apr;1(2):48-52. doi: 10.4161/jig.1.2.16826.
Results Reference
result
PubMed Identifier
1397911
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. doi: 10.1016/s0016-5107(92)70517-3.
Results Reference
result
PubMed Identifier
18959640
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.
Results Reference
result
PubMed Identifier
21611947
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.
Results Reference
result

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

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