Clinical trial NCT02978664: The Impact of Distraction on Adenoma Detection Rate
Official title: The Impact of Distraction on Adenoma Detection Rate in Patients Undergoing Colonoscopy With Air Insufflation, Water Immersion and Water Exchange
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoma
Keywords: colonoscopy
water exchange
adenoma detection rate
distraction
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: adenoma detection rate
timeFrame: one week after colonoscopy
Secondary outcomes:
measure: Distraction score
timeFrame: Immediate after video reviewing
measure: Withdrawal technique as specified by Lee RH (citation 1)
timeFrame: immediate after video reviewing
measure: Bowel preparation score
timeFrame: immediate after video reviewing
Other outcomes:
Locations:
city: Chia-Yi
country: Taiwan
facility: Buddhist Dalin Tzu Chi General Hospital
Study officials:
affiliation: Dalin Tzu Chi General Hospital
name: Yu-Hsi Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee RH, Tang RS, Muthusamy VR, Ho SB, Shah NK, Wetzel L, Bain AS, Mackintosh EE, Paek AM, Crissien AM, Saraf LJ, Kalmaz DM, Savides TJ. Quality of colonoscopy withdrawal technique and variability in adenoma detection rates (with videos). Gastrointest Endosc. 2011 Jul;74(1):128-34. doi: 10.1016/j.gie.2011.03.003. Epub 2011 Apr 30.
citation: Leung FW. Water exchange may be superior to water immersion for colonoscopy. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1012-4. doi: 10.1016/j.cgh.2011.09.007. Epub 2011 Sep 22. No abstract available.
citation: Yung VY, Yen AW, Leung JW, Mann SK, Wilson MD, Leung FW. Validation of a novel method for analyzing video recordings of the withdrawal phase of air insufflation and water exchange colonoscopy - documentation of distractions from focused mucosal inspection. J Interv Gastroenterol. 2014 Jan;4(1):8-12.
citation: Hsieh YH, Koo M, Tseng CW, Yang HW, Leung FW. Reduction of multitasking distractions underlies the higher adenoma detection rate of water exchange compared to air insufflation - blinded analysis of withdrawal phase videos. United European Gastroenterol J. 2019 Mar;7(2):230-238. doi: 10.1177/2050640618817105. Epub 2018 Dec 5.