NCT02978664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

April 8, 2016

Last Update Submit

November 28, 2016

Conditions

Adenoma

Keywords

colonoscopywater exchangeadenoma detection ratedistraction

Outcome Measures

Primary Outcomes (1)

  • adenoma detection rate

    one week after colonoscopy

Secondary Outcomes (3)

  • Distraction score

    Immediate after video reviewing

  • Withdrawal technique as specified by Lee RH (citation 1)

    immediate after video reviewing

  • Bowel preparation score

    immediate after video reviewing

Study Arms (3)

Air insufflation

ACTIVE COMPARATOR

Air insufflation will be used throughout whole procedure of colonoscopy

Procedure: Air insufflation

water immersion

ACTIVE COMPARATOR

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

Procedure: water immersion

water exchange

ACTIVE COMPARATOR

Water will be infused and removed during insertion phase of colonoscopy

Procedure: Water exchange

Interventions

Air insufflationPROCEDURE

Air insufflation during colonoscopy including insertion phase

Air insufflation
water immersionPROCEDURE

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

water immersion
Water exchangePROCEDURE

Water will infused and removed during insertion phase of colonoscopy

water exchange

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buddhist Dalin Tzu Chi General Hospital

Chiayi City, Taiwan, 622, Taiwan

Location

Related Publications (4)

  • 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.

    PMID: 21531410BACKGROUND

  • 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.

    PMID: 21946120BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 31080608DERIVED

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Yu-Hsi Hsieh, MD

    Dalin Tzu Chi General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2016

First Posted

December 1, 2016

Study Start

October 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 1, 2016

Record last verified: 2016-11

Locations

TW(1)