NCT02759081

Brief Summary

This prospective, randomize, controlled trial will compared cap-assisted water exchange with water exchange in patients undergoing sedated colonoscopy. Investigators test the hypothesis that that cap-assisted water exchange is more efficient and causes a shorter insertion time.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

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

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
Last Updated

May 3, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

April 5, 2016

Last Update Submit

April 29, 2016

Conditions

ColonoscopyIntubation TimeCap-assisted Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • cecal intubation time

    when the colonoscope reaches the cecum, an average of 14 minutes

Secondary Outcomes (2)

  • Dose of propofol

    The end of colonoscopy, an average of 14 minutes

  • adenoma detection rate

    One week after colonoscopy

Study Arms (2)

water exchange

ACTIVE COMPARATOR

The air was turned off at the beginning of colonoscopy. Water was infused and suctioned at the same time during insertion. The air was turned on when the colonoscope reached the cecum.

Procedure: water exchange

cap-assisted water exchange

EXPERIMENTAL

Cap was mounted to the tip of the colonoscope when water exchange was performed.

Device: cap-assisted water exchangeProcedure: water exchange

Interventions

cap-assisted water exchangeDEVICE

a transparent cap was mounted to the tip of colonoscopy when water exchange was performed.

cap-assisted water exchange
water exchangePROCEDURE

water was infused and suctioned at the same time during insertion of colonoscope

cap-assisted water exchangewater exchange

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing fully sedated colonoscopy performed by the investigators

You may not qualify if:

  • obstructive lesions of the colon
  • massive ascites
  • history of partial colectomy
  • provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalin Tzu Chi General Hospital

Chiayi City, Taiwan, 622, Taiwan

Location

Related Publications (4)

  • Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.

    PMID: 22898423BACKGROUND

  • Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13.

    PMID: 21997547BACKGROUND

  • Kondo S, Yamaji Y, Watabe H, Yamada A, Sugimoto T, Ohta M, Ogura K, Okamoto M, Yoshida H, Kawabe T, Omata M. A randomized controlled trial evaluating the usefulness of a transparent hood attached to the tip of the colonoscope. Am J Gastroenterol. 2007 Jan;102(1):75-81. doi: 10.1111/j.1572-0241.2006.00897.x. Epub 2006 Nov 13.

    PMID: 17100978BACKGROUND

  • Lee YT, Lai LH, Hui AJ, Wong VW, Ching JY, Wong GL, Wu JC, Chan HL, Leung WK, Lau JY, Sung JJ, Chan FK. Efficacy of cap-assisted colonoscopy in comparison with regular colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2009 Jan;104(1):41-6. doi: 10.1038/ajg.2008.56.

    PMID: 19098847BACKGROUND

Study Officials

  • Yu-Hsi Hsieh, MD

    Dalin Tzu Chi Hospital. Tzu Chi medication Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of endoscopy suite, deparment of Gastroenterology

Study Record Dates

First Submitted

April 5, 2016

First Posted

May 3, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Last Updated

May 3, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)