Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange

June 27, 2016 updated by: Yu-Hsi hsieh, Dalin Tzu Chi General Hospital

A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Colonoscopy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All of the procedures will be recorded and stored as digital files.

Study Type

Interventional

Enrollment (Actual)

651

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Chia-Yi, Taiwan, 622
        • Dalin Tzu Chi General Hospital
  • United States
    • California
      • North Hills, California, United States, 91343
        • Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: air insufflation
Air insufflation will be used throughout whole procedure of colonoscopy
Procedure: Air insufflation
Insufflation during colonoscopy including insertion phase
Active Comparator: water immersion
Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy.
Procedure: water immersion
Water will infused during insertion phase and removed during withdrawal phase of colonoscopy
Active Comparator: water exchange
Water will be infused and removed during insertion phase of colonoscopy
Procedure: Water exchange
Water will infused and removed during insertion phase of colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adenoma detection rate
Time Frame: one week
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adenoma detection rate in proximal colon
Time Frame: one week
the proportion of patients with the presence of adenoma in the proximal colon
one week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-procedure discomfort and 30 days complication rate
Time Frame: 30 days
telephone follow up for post-procedure discomfort and 30 days complication rate
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalin Tzu Chi General Hospital

Collaborators

Sepulveda Ambulatory Care Center, VAGLAHS

Investigators

  • Principal Investigator: Yu-Hsi Hsieh, MD, Buddhist Dalin Tzu Chi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 3, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

June 28, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DalinTCGH-hsieh-03

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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