NCT01699399

Brief Summary

This prospective, randomized controlled trial compares traditional air insufflation with water immersion and water exchange in patients undergoing colonoscopy using on demand sedation. We test the hypothesis that compared with air insufflation the proportion of patients who require on demand sedation during colonoscopy will be significantly lowered by water immersion and water exchange, and water exchange will produce the greatest reduction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Longer than 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

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

6.3 years

First QC Date

September 30, 2012

Last Update Submit

May 19, 2019

Conditions

Colon Neoplasm

Keywords

colonoscopypainsedationwater

Outcome Measures

Primary Outcomes (1)

  • Proportions of patients requiring sedation

    3 months

Secondary Outcomes (1)

  • patient pain during insertion

    3 months

Other Outcomes (1)

  • post-procedure discomforts and 30 days complication rate

    one month

Study Arms (3)

water immersion

EXPERIMENTAL

infuse water during insertion phase of colonoscopy instead of air insufflation; remove the water during withdrawal phase.

Procedure: water immersion

water exchange

EXPERIMENTAL

infuse and remove water during the insertion phase of colonoscopy. Air insufflation is used only in the withdrawal phase

Procedure: water exchange

air insufflation

ACTIVE COMPARATOR

standard colonoscopy using traditional air insufflation during insertion

Procedure: air insufflation

Interventions

water immersionPROCEDURE
water immersion
water exchangePROCEDURE
water exchange
air insufflationPROCEDURE
air insufflation

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 endoscopist at our endoscopic suite

You may not qualify if:

  • request for sedation, indicated for bidirectional endoscopy, obstructive lesions of the colon, allergy to meperidine or propofol, American Society of Anesthesiology (ASA) risk Class 3 or higher, massive ascites, past history of partial colectomy, or refusal to 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 (3)

  • 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

  • Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8.

    PMID: 20619405BACKGROUND

  • 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

MeSH Terms

Conditions

Colonic NeoplasmsPain

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yu-Hsi Hsieh, M.D.

    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
PRINCIPAL INVESTIGATOR
PI Title
Chief of department of gastroenterology and hepatology

Study Record Dates

First Submitted

September 30, 2012

First Posted

October 3, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 21, 2019

Record last verified: 2019-05

Locations

TW(1)