Trial record 5 of 199 for:    Open Studies | "Drinking Water"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Dalin Tzu Chi General Hospital
Sponsor:
Collaborator:
Felix Leung, MD, Sepulveda Ambulatory Care Center, VAGLAHS
Information provided by (Responsible Party):
Yu-Hsi hsieh, Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01894191
First received: July 3, 2013
Last updated: July 29, 2014
Last verified: July 2014
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: 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 Dalin Tzu Chi General Hospital:

Primary Outcome Measures:
  • adenoma detection rate in the right colon [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall adenoma detection rate [ Time Frame: one week ] [ Designated as safety issue: No ]
    the proportion of presence of adenoma in the patient


Other Outcome Measures:
  • post-procedure discomfort and 30 days complication rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    telephone follow up for post-procedure discomfort and 30 days complication rate


Estimated Enrollment: 330
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01894191

Contacts
Contact: Yu-Hsi Hsieh, MD 886-5-2648000 ext 5204 hsieh.yuhsi@msa.hinet.net

Locations
United States, California
Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System Active, not recruiting
North Hills, California, United States, 91343
Taiwan
Dalin Tzu Chi General Hospital Recruiting
Chia-Yi, Taiwan, 622
Contact: Yu-Hsi Hsieh, MD       hsieh.yuhsi@msa.hinet.net   
Principal Investigator: Yu-Hsi Hsieh, MD         
Sponsors and Collaborators
Dalin Tzu Chi General Hospital
Felix Leung, MD, 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
Study First Received: July 3, 2013
Last Updated: July 29, 2014
Health Authority: Taiwan: Institutional Review Board of Dalin Tzu Chi General Hospital

Keywords provided by 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

ClinicalTrials.gov processed this record on September 11, 2014