NCT02737514

Brief Summary

Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. An independent predictor of the risk of interval cancers is adenoma detection rate. In pilot observations, the investigators showed that water exchange enhanced adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized controlled trial will compare water exchange with water immersion and traditional air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that compared with air insufflation and water immersion, water exchange produces a significantly higher adenoma detection rate in the right colon

Trial Health

90
On Track

Trial Health Score

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

Enrollment
371

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

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

First Submitted

Initial submission to the registry

August 25, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

4.2 years

First QC Date

August 25, 2015

Last Update Submit

May 28, 2020

Conditions

Adenoma

Keywords

adenoma detection ratecolonoscopywater exchange

Outcome Measures

Primary Outcomes (1)

  • adenoma detection rate in the right colon

    one week

Secondary Outcomes (3)

  • overall adenoma detection rate

    one week

  • post-procedure discomfort

    1 day after colonoscopy

  • 30 days complication rate

    30 days

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

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:

  • Patients undergoing colonoscopy performed by the participating endoscopists

You may not qualify if:

  • obstructive lesions of the colon known before colonoscopy
  • massive ascites
  • past history of partial colectomy
  • refusal to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sepulveda Ambulatory Care Center, Veterans Affairs Greater

North Hills, California, United States

Location

Dalin Tzu Chi General Hospital

Chiayi City, Taiwan, 622, Taiwan

Location

Related Publications (5)

  • Bressler B, Paszat LF, Vinden C, Li C, He J, Rabeneck L. Colonoscopic miss rates for right-sided colon cancer: a population-based analysis. Gastroenterology. 2004 Aug;127(2):452-6. doi: 10.1053/j.gastro.2004.05.032.

    PMID: 15300577BACKGROUND

  • Stock C, Pulte D, Haug U, Brenner H. Subsite-specific colorectal cancer risk in the colorectal endoscopy era. Gastrointest Endosc. 2012 Mar;75(3):621-30. doi: 10.1016/j.gie.2011.10.025.

    PMID: 22341107BACKGROUND

  • 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

  • Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.

    PMID: 20883846BACKGROUND

  • Hsieh YH, Lin HJ, Tseng KC. Limited water infusion decreases pain during minimally sedated colonoscopy. World J Gastroenterol. 2011 May 7;17(17):2236-40. doi: 10.3748/wjg.v17.i17.2236.

    PMID: 21633535BACKGROUND

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Yu-Hsi Hsieh, MD

    Buddhist Dalin Tzu Chi General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 25, 2015

First Posted

April 14, 2016

Study Start

December 1, 2015

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations

US(1)TW(1)