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Completed

NCT Number: NCT02737514

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

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Key information

Conditions

Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dalin Tzu Chi General Hospital, Chiayi City, Taiwan

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

air insufflation

Procedure

Insufflation during colonoscopy including insertion phase

Water immersion

Procedure

Water will infused during insertion phase and removed during withdrawal phase of colonoscopy

water exchange

Procedure

Water will infused and removed during insertion phase of colonoscopy

Primary outcomes

  1. adenoma detection rate in the right colon

    Time frame: one week

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Dalin Tzu Chi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2016
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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