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Water Immersion and Polyp Detection: A Randomized Controlled Trial

Primary Purpose

Adenoma, Colonic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water Infusion first
CO2 Insufflation First
Sponsored by
White River Junction Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Adenoma

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • all adults 50 years or older who present for colonoscopy at White River Junction VAMC and Indiana University

Exclusion Criteria:

  • includes co-morbid status of ASA III or higher, Inflammatory Bowel Disease (IBD), surgical resection of the large bowel, as well as the use of anticoagulants. Finally, potential subjects who do not report a clear effluent in the most recent bowel movement will be excluded from the study.

Sites / Locations

  • University of Connecticut Health Center
  • Indiana University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Water Infusion first

CO2 Insufflation First

Arm Description

In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.

In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion.

Outcomes

Primary Outcome Measures

Adenoma Miss Rate
Adenoma-level miss rates will be calculated as the number of additional adenomas detected during the second examination divided by the total number of adenomas detected during both examinations

Secondary Outcome Measures

Patient-level Miss Rate
Patient-level miss rates will be calculated as the number of patients with one or more adenomas detected during the second examination, divided by the total number of patients with at least one adenoma in either examination
Adenoma < 6mm Detection Rate
Adenoma-level miss rates will be calculated as the number of additional adenomas < 6 mm detected during the second examination divided by the total number of adenomas< 6 mm detected during both examinations.

Full Information

First Posted
July 25, 2017
Last Updated
April 23, 2019
Sponsor
White River Junction Veterans Affairs Medical Center
Collaborators
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT03231917
Brief Title
Water Immersion and Polyp Detection: A Randomized Controlled Trial
Official Title
Water Immersion and Polyp Detection: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
White River Junction Veterans Affairs Medical Center
Collaborators
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
We plan to conduct a randomized trial of tandem colonoscopies comparing water infusion and air insufflation for inspection of mucosa on withdrawal. In one randomized group, water infusion will be employed as the first method for mucosal inspection while in a second group, CO2 insufflation will be used first. This study will be different than usual care since the participants will receive two successive or tandem colonoscopies versus one

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma, Colonic Neoplasms

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
In one randomized group, water infusion will be employed as the first method for mucosal inspection while in a second group, CO2 insufflation will be used first. This study will be different than usual care since the participants will receive two successive or tandem colonoscopies versus one
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water Infusion first
Arm Type
Experimental
Arm Description
In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
Arm Title
CO2 Insufflation First
Arm Type
Experimental
Arm Description
In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion.
Intervention Type
Procedure
Intervention Name(s)
Water Infusion first
Intervention Description
In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
Intervention Type
Procedure
Intervention Name(s)
CO2 Insufflation First
Intervention Description
In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion .
Primary Outcome Measure Information:
Title
Adenoma Miss Rate
Description
Adenoma-level miss rates will be calculated as the number of additional adenomas detected during the second examination divided by the total number of adenomas detected during both examinations
Time Frame
Through procedure, an average of 1 hr
Secondary Outcome Measure Information:
Title
Patient-level Miss Rate
Description
Patient-level miss rates will be calculated as the number of patients with one or more adenomas detected during the second examination, divided by the total number of patients with at least one adenoma in either examination
Time Frame
1 hour or the duration of the procedure
Title
Adenoma < 6mm Detection Rate
Description
Adenoma-level miss rates will be calculated as the number of additional adenomas < 6 mm detected during the second examination divided by the total number of adenomas< 6 mm detected during both examinations.
Time Frame
1 hour or the duration of the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: all adults 50 years or older who present for colonoscopy at White River Junction VAMC and Indiana University Exclusion Criteria: includes co-morbid status of ASA III or higher, Inflammatory Bowel Disease (IBD), surgical resection of the large bowel, as well as the use of anticoagulants. Finally, potential subjects who do not report a clear effluent in the most recent bowel movement will be excluded from the study.
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30367879
Citation
Anderson JC, Kahi CJ, Sullivan A, MacPhail M, Garcia J, Rex DK. Comparing adenoma and polyp miss rates for total underwater colonoscopy versus standard CO2: a randomized controlled trial using a tandem colonoscopy approach. Gastrointest Endosc. 2019 Mar;89(3):591-598. doi: 10.1016/j.gie.2018.09.046. Epub 2018 Oct 24.
Results Reference
derived

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Water Immersion and Polyp Detection: A Randomized Controlled Trial

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