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Comparing the ADR With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy

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ClinicalTrials.gov Identifier: NCT02737514
Recruitment Status : Unknown
Verified February 2016 by Dalin Tzu Chi General Hospital.
Recruitment status was:  Recruiting
First Posted : April 14, 2016
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Dalin Tzu Chi General Hospital

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

Condition or disease Intervention/treatment Phase
Adenoma Procedure: Air insufflation Procedure: water immersion Procedure: water exchange Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy
Study Start Date : December 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. adenoma detection rate in the right colon [ Time Frame: one week ]

Secondary Outcome Measures :
  1. overall adenoma detection rate [ Time Frame: one week ]
  2. post-procedure discomfort [ Time Frame: 1 day after colonoscopy ]
    pain or distention on a 0 to 10 VAS scale

  3. 30 days complication rate [ Time Frame: 30 days ]
    incidence of bleeding, perforation and unexpected admission



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
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

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): NCT02737514


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

Locations
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United States, California
Sepulveda Ambulatory Care Center, Veterans Affairs Greater Active, not recruiting
North Hills, California, United States
Taiwan
Dalin Tzu Chi General Hospital Recruiting
Chia-Yi, Taiwan, 622
Contact: Yu-Hsi Hsieh, MD    886052648000 ext 5242    hsieh.yuhsi@msa.hinet.net   
Principal Investigator: Yu-Hsi Hsieh, M.D.         
Sponsors and Collaborators
Dalin Tzu Chi General Hospital
Investigators
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Principal Investigator: Yu-Hsi Hsieh, MD Buddhist Dalin Tzu Chi General Hospital

Publications:
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Responsible Party: Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT02737514     History of Changes
Other Study ID Numbers: DalinHsieh201402
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: February 2016
Keywords provided by Dalin Tzu Chi General Hospital:
adenoma detection rate
colonoscopy
water exchange
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms