Back to resultsComparing the ADR With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy
Primary Purpose
Adenoma
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Air insufflation
water immersion
water exchange
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenoma focused on measuring adenoma detection rate, colonoscopy, water exchange
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing colonoscopy performed by the participating endoscopists
Exclusion Criteria:
- obstructive lesions of the colon known before colonoscopy
- massive ascites
- past history of partial colectomy
- refusal to provide written informed consent
Sites / Locations
- Sepulveda Ambulatory Care Center, Veterans Affairs Greater
- Dalin Tzu Chi General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
air insufflation
water immersion
water exchange
Arm Description
Air insufflation will be used throughout whole procedure of colonoscopy
Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy
Water will be infused and removed during insertion phase of colonoscopy
Outcomes
Primary Outcome Measures
adenoma detection rate in the right colon
Secondary Outcome Measures
overall adenoma detection rate
post-procedure discomfort
pain or distention on a 0 to 10 VAS scale
30 days complication rate
incidence of bleeding, perforation and unexpected admission
Full Information
NCT ID
NCT02737514
First Posted
August 25, 2015
Last Updated
May 28, 2020
Sponsor
Dalin Tzu Chi General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02737514
Brief Title
Comparing the ADR With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy
Official Title
A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dalin Tzu Chi General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. An independent predictor of the risk of interval cancers is adenoma detection rate. In pilot observations, the investigators showed that water exchange enhanced adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized controlled trial will compare water exchange with water immersion and traditional air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that compared with air insufflation and water immersion, water exchange produces a significantly higher adenoma detection rate in the right colon
Detailed Description
All of the procedures will be recorded and stored as digital files.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma
Keywords
adenoma detection rate, colonoscopy, water exchange
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
371 (Actual)
8. Arms, Groups, and Interventions
Arm Title
air insufflation
Arm Type
Active Comparator
Arm Description
Air insufflation will be used throughout whole procedure of colonoscopy
Arm Title
water immersion
Arm Type
Active Comparator
Arm Description
Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy
Arm Title
water exchange
Arm Type
Active Comparator
Arm Description
Water will be infused and removed during insertion phase of colonoscopy
Intervention Type
Procedure
Intervention Name(s)
Air insufflation
Intervention Description
Insufflation during colonoscopy including insertion phase
Intervention Type
Procedure
Intervention Name(s)
water immersion
Intervention Description
Water will infused during insertion phase and removed during withdrawal phase of colonoscopy
Intervention Type
Procedure
Intervention Name(s)
water exchange
Intervention Description
Water will infused and removed during insertion phase of colonoscopy
Primary Outcome Measure Information:
Title
adenoma detection rate in the right colon
Time Frame
one week
Secondary Outcome Measure Information:
Title
overall adenoma detection rate
Time Frame
one week
Title
post-procedure discomfort
Description
pain or distention on a 0 to 10 VAS scale
Time Frame
1 day after colonoscopy
Title
30 days complication rate
Description
incidence of bleeding, perforation and unexpected admission
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing colonoscopy performed by the participating endoscopists
Exclusion Criteria:
obstructive lesions of the colon known before colonoscopy
massive ascites
past history of partial colectomy
refusal to provide written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Hsi Hsieh, MD
Organizational Affiliation
Buddhist Dalin Tzu Chi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sepulveda Ambulatory Care Center, Veterans Affairs Greater
City
North Hills
State/Province
California
Country
United States
Facility Name
Dalin Tzu Chi General Hospital
City
Chia-Yi
ZIP/Postal Code
622
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
15300577
Citation
Bressler B, Paszat LF, Vinden C, Li C, He J, Rabeneck L. Colonoscopic miss rates for right-sided colon cancer: a population-based analysis. Gastroenterology. 2004 Aug;127(2):452-6. doi: 10.1053/j.gastro.2004.05.032.
Results Reference
background
PubMed Identifier
22341107
Citation
Stock C, Pulte D, Haug U, Brenner H. Subsite-specific colorectal cancer risk in the colorectal endoscopy era. Gastrointest Endosc. 2012 Mar;75(3):621-30. doi: 10.1016/j.gie.2011.10.025.
Results Reference
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PubMed Identifier
22898423
Citation
Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.
Results Reference
background
PubMed Identifier
20883846
Citation
Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.
Results Reference
background
PubMed Identifier
21633535
Citation
Hsieh YH, Lin HJ, Tseng KC. Limited water infusion decreases pain during minimally sedated colonoscopy. World J Gastroenterol. 2011 May 7;17(17):2236-40. doi: 10.3748/wjg.v17.i17.2236.
Results Reference
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Comparing the ADR With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy
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