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Completed

NCT Number: NCT02978664

The Impact of Distraction on Adenoma Detection Rate

The investigators will review video-recordings of three randomized, controlled trials (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water exchange during colonoscopy. These studies were all conducted at Buddhist Dalin Tzu Chi Hospital.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Buddhist Dalin Tzu Chi General Hospital

Chiayi City, Taiwan, 622

About this study

The investigators will review video-recordings of three randomized controlled trials (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water exchange. These studies were conducted at Buddhist Dalin Tzu Chi Hospital. Permission will be obtained from the local Institutional Review Board (IRB) to review, analyze and report de-identified findings.

Two experienced endoscopists (YHH and CWT) performed all the recorded colonoscopies. Recordings will be selected for review if they are complete examinations; include clear identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the appropriate format for video editing; and contain no patient or endoscopist identifiers. Patients with incomplete recordings and a history of bowel resection will be excluded from analysis. The included video recordings will be edited to remove the insertion phase to blind the study reviewer to the insertion techniques. One blinded reviewer uninvolved in the performance of the colonoscopies will be in charge of evaluating the selected videos, using the criteria described by Yung et al

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • if they are complete examinations; include clear identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the appropriate format for video editing; and contain no patient or endoscopist identifiers.

Exclusion criteria

  • Patients with incomplete recordings and a history of bowel resection will be excluded from analysis.

Treatment and study plan

air insufflation

Procedure

Air 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

    Time frame: one week after colonoscopy

Secondary outcomes

  1. Distraction score

    Time frame: Immediate after video reviewing

  2. Withdrawal technique as specified by Lee RH (citation 1)

    Time frame: immediate after video reviewing

    adequacy of distention (0-5), fold examination (0-5) and cleaning (0-5) for each colonic segment

  3. Bowel preparation score

    Time frame: immediate after video reviewing

    Boston bowel preparation score

Sponsors and collaborators

Lead sponsor

Dalin Tzu Chi General Hospital

Other

Registry information

Official study title

The Impact of Distraction on Adenoma Detection Rate in Patients Undergoing Colonoscopy With Air Insufflation, Water Immersion and Water Exchange

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 1, 2016
Registry last updated
Dec 1, 2016

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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