We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01894191
First Posted: July 10, 2013
Last Update Posted: June 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sepulveda Ambulatory Care Center, VAGLAHS
Information provided by (Responsible Party):
Yu-Hsi hsieh, Dalin Tzu Chi General Hospital
  Purpose
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.

Condition Intervention
Adenoma Procedure: Air insufflation Procedure: water immersion Procedure: Water exchange

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Colonoscopy

Resource links provided by NLM:


Further study details as provided by Yu-Hsi hsieh, Dalin Tzu Chi General Hospital:

Primary Outcome Measures:
  • adenoma detection rate [ Time Frame: one week ]

Secondary Outcome Measures:
  • adenoma detection rate in proximal colon [ Time Frame: one week ]
    the proportion of patients with the presence of adenoma in the proximal colon


Other Outcome Measures:
  • post-procedure discomfort and 30 days complication rate [ Time Frame: 30 days ]
    telephone follow up for post-procedure discomfort and 30 days complication rate


Enrollment: 651
Study Start Date: May 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
All of the procedures will be recorded and stored as digital files.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894191


Locations
United States, California
Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System
North Hills, California, United States, 91343
Taiwan
Dalin Tzu Chi General Hospital
Chia-Yi, Taiwan, 622
Sponsors and Collaborators
Dalin Tzu Chi General Hospital
Sepulveda Ambulatory Care Center, VAGLAHS
Investigators
Principal Investigator: Yu-Hsi Hsieh, MD Buddhist Dalin Tzu Chi Hospital
  More Information

Publications:
Responsible Party: Yu-Hsi hsieh, Doctor, Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01894191     History of Changes
Other Study ID Numbers: DalinTCGH-hsieh-03
First Submitted: July 3, 2013
First Posted: July 10, 2013
Last Update Posted: June 28, 2016
Last Verified: June 2016

Keywords provided by Yu-Hsi hsieh, Dalin Tzu Chi General Hospital:
adenoma detection rate
colonoscopy
water exchange

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms