Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy

NCT ID: NCT02759081

Last Updated: 2016-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colonoscopy Intubation Time Cap-assisted Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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water exchange

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.

Group Type ACTIVE_COMPARATOR

water exchange

Intervention Type PROCEDURE

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

cap-assisted water exchange

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

Group Type EXPERIMENTAL

cap-assisted water exchange

Intervention Type DEVICE

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

water exchange

Intervention Type PROCEDURE

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

Interventions

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cap-assisted water exchange

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

Intervention Type DEVICE

water exchange

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing fully sedated colonoscopy performed by the investigators

Exclusion Criteria

* obstructive lesions of the colon
* massive ascites
* history of partial colectomy
* provide written informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dalin Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yu-Hsi hsieh

Chief of endoscopy suite, deparment of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu-Hsi Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

Dalin Tzu Chi Hospital. Tzu Chi medication Foundation

Locations

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Dalin Tzu Chi General Hospital

Chiayi City, Taiwan, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 22898423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21997547 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17100978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19098847 (View on PubMed)

Other Identifiers

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Hsieh-2016-01

Identifier Type: -

Identifier Source: org_study_id

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