RCT of Air Insufflation Versus Water Infusion Colonoscopy
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
water infusion colonoscopy
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring Colorectal cancer screening, optical colonoscopy, water method, sedation
Eligibility Criteria
Inclusion Criteria:
- healthy individual 50 years or older
- eligible for colorectal cancer screening or surveillance
Exclusion Criteria:
- patients who do not understand or failed to sign informed consent
Sites / Locations
- Sacramento VA Medical Center, VANCHCS
Outcomes
Primary Outcome Measures
Increments of medications used for sedation
Secondary Outcome Measures
pain scores during colonoscopy
success with cecal intubation
willingness to repeat colonoscopy
Full Information
NCT ID
NCT00785889
First Posted
November 3, 2008
Last Updated
November 13, 2008
Sponsor
East Bay Institute for Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT00785889
Brief Title
RCT of Air Insufflation Versus Water Infusion Colonoscopy
Official Title
A Randomized Controlled Comparison of Warm Water Infusion in Lieu of Air Insufflation vs. Air Insufflation for Aiding Colonoscopy Insertion in Sedated Patients Undergoing Colorectal Cancer (CRC) Screening and Surveillance.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
East Bay Institute for Research and Education
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Compared with the conventional (air) method, patients examined by the study (water) method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.
Detailed Description
Background: A novel water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without medications and significantly increased successful cecal intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy.
Aim: To perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients.
Hypothesis: Compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.
Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The conventional and the study method for colonoscopy were implemented as previously described. Additional pain medications were administered at the patients' request.
Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy.
Limitations: Single VA site, older male population
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer screening, optical colonoscopy, water method, sedation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
water infusion colonoscopy
Other Intervention Name(s)
optical colonoscopy, water infusion colonoscopy
Intervention Description
water infusion in lieu of air insufflation for screening colonoscopy
Primary Outcome Measure Information:
Title
Increments of medications used for sedation
Time Frame
duration of procedure
Secondary Outcome Measure Information:
Title
pain scores during colonoscopy
Time Frame
duration of procedure
Title
success with cecal intubation
Time Frame
during procedure
Title
willingness to repeat colonoscopy
Time Frame
after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy individual 50 years or older
eligible for colorectal cancer screening or surveillance
Exclusion Criteria:
patients who do not understand or failed to sign informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Leung, MD
Organizational Affiliation
Sacramento VA Medical Center, GI Section
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sacramento VA Medical Center, VANCHCS
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17661766
Citation
Leung JW, Mann S, Leung FW. Options for screening colonoscopy without sedation: a pilot study in United States veterans. Aliment Pharmacol Ther. 2007 Aug 15;26(4):627-31. doi: 10.1111/j.1365-2036.2007.03404.x.
Results Reference
background
PubMed Identifier
18461455
Citation
Leung FW. Water-related techniques for performance of colonoscopy. Dig Dis Sci. 2008 Nov;53(11):2847-50. doi: 10.1007/s10620-008-0259-1. Epub 2008 May 7.
Results Reference
background
PubMed Identifier
18374030
Citation
Leung FW, Aharonian HS, Guth PH, Chu SK, Nguyen BD, Simpson P. Involvement of trainees in routine unsedated colonoscopy: review of a pilot experience. Gastrointest Endosc. 2008 Apr;67(4):718-22. doi: 10.1016/j.gie.2007.11.040.
Results Reference
background
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
derived
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RCT of Air Insufflation Versus Water Infusion Colonoscopy
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