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Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange

Primary Purpose

Adenoma

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Air insufflation

water immersion

Water exchange

About this trial

This is an interventional diagnostic trial for Adenoma focused on measuring adenoma detection rate, colonoscopy, water exchange

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients undergoing colonoscopy performed by the participating endoscopists

Exclusion Criteria:

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

Sites / Locations

Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System
Dalin Tzu Chi General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

air insufflation

water immersion

water exchange

Arm Description

Air insufflation will be used throughout whole procedure of colonoscopy

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

Water will be infused and removed during insertion phase of colonoscopy

Outcomes

Primary Outcome Measures

adenoma detection rate

Secondary Outcome Measures

adenoma detection rate in proximal colon

the proportion of patients with the presence of adenoma in the proximal colon

Full Information

NCT ID

NCT01894191

First Posted

July 3, 2013

Last Updated

June 27, 2016

Sponsor

Dalin Tzu Chi General Hospital

Collaborators

Sepulveda Ambulatory Care Center, VAGLAHS

1. Study Identification

Unique Protocol Identification Number

NCT01894191

Brief Title

Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange

Official Title

A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Colonoscopy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dalin Tzu Chi General Hospital

Collaborators

Sepulveda Ambulatory Care Center, VAGLAHS

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

All of the procedures will be recorded and stored as digital files.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenoma

Keywords

adenoma detection rate, colonoscopy, water exchange

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

651 (Actual)

8. Arms, Groups, and Interventions

Arm Title

air insufflation

Arm Type

Active Comparator

Arm Description

Air insufflation will be used throughout whole procedure of colonoscopy

Arm Title

water immersion

Arm Type

Active Comparator

Arm Description

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

Arm Title

water exchange

Arm Type

Active Comparator

Arm Description

Water will be infused and removed during insertion phase of colonoscopy

Intervention Type

Procedure

Intervention Name(s)

Air insufflation

Intervention Description

Insufflation during colonoscopy including insertion phase

Intervention Type

Procedure

Intervention Name(s)

water immersion

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Water exchange

Intervention Description

Water will infused and removed during insertion phase of colonoscopy

Primary Outcome Measure Information:

Title

adenoma detection rate

Time Frame

one week

Secondary Outcome Measure Information:

Title

adenoma detection rate in proximal colon

Description

the proportion of patients with the presence of adenoma in the proximal colon

Time Frame

one week

Other Pre-specified Outcome Measures:

Title

post-procedure discomfort and 30 days complication rate

Description

telephone follow up for post-procedure discomfort and 30 days complication rate

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients undergoing colonoscopy performed by the participating endoscopists Exclusion Criteria: obstructive lesions of the colon known before colonoscopy massive ascites past history of partial colectomy refusal to provide written informed consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yu-Hsi Hsieh, MD

Organizational Affiliation

Buddhist Dalin Tzu Chi Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System

City

North Hills

State/Province

California

ZIP/Postal Code

91343

Country

United States

Facility Name

Dalin Tzu Chi General Hospital

City

Chia-Yi

ZIP/Postal Code

622

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

15300577

Citation

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.

Results Reference

background

PubMed Identifier

22341107

Citation

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.

Results Reference

background

PubMed Identifier

22898423

Citation

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.

Results Reference

background

PubMed Identifier

20883846

Citation

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.

Results Reference

background

PubMed Identifier

21633535

Citation

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.

Results Reference

background

PubMed Identifier

27988288

Citation

Hsieh YH, Tseng CW, Hu CT, Koo M, Leung FW. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation. Gastrointest Endosc. 2017 Jul;86(1):192-201. doi: 10.1016/j.gie.2016.12.005. Epub 2016 Dec 15.

Results Reference

derived

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Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange

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