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The efficacy of the Integrated Water Jet Channel Colonoscopy in Water Exchange Method

Primary Purpose

Colonoscopy, Colon Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Water jet channel
Accessory channel
Sponsored by
Chih-wei Tseng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonoscopy focused on measuring water exchange, water jet channel colonoscopy, colonoscopy, cecal insertion time, adenoma detection rate

Eligibility Criteria

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

Inclusion Criteria:

  • Underwent fully sedative colonoscopy with WE method in the outpatient department

Exclusion Criteria:

  • Age < 18 years old or > 80 years old
  • Without standard colon preparation
  • Allergy to meperidine or propofol
  • With a history of partial colectomy
  • Refusal to provide written informed consent.

Sites / Locations

  • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Two-channel group

One-channel group

Arm Description

The colonoscopy was done with the new designed colonoscopy that integrated a separate water jet channel for infusing water. The dirty water was removed through other accessory channel.

The colonoscopy was done with the traditional colonoscopy. Water exchange was done by using the accessory channel for both infusing and suctioning of water.

Outcomes

Primary Outcome Measures

cecal insertion time
Cecal insertion time was defined as the time from insertion into the rectum to the time when the colonoscope tip passed to a point proximal to the ileocecal valve so that the base of cecum was visible.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2017
Last Updated
October 25, 2019
Sponsor
Chih-wei Tseng
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1. Study Identification

Unique Protocol Identification Number
NCT03279705
Brief Title
The efficacy of the Integrated Water Jet Channel Colonoscopy in Water Exchange Method
Official Title
Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chih-wei Tseng

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This prospective randomized controlled trial compared integrated water jet channel colonoscopy with traditional accessory channel colonoscopy in cecal insertion time among patients undergoing WE method colonoscopy.
Detailed Description
When the WE method colonoscopy were done with the accessory channel for both infusing and suctioning of water. The water had to be suctioned or infused alternatively and increaed the insertion time. With the new designed endoscopy that integrated a separate water jet channel for infusing water, infusing and suctioning of water can be done at the same time. Besides, water jet pumping system could provide a powerful jet to help us open the collapse lumen and keep an appropriate distance between the mucosa and the lens, thus preventing loss of visualization. It will help the colonoscopist to find the way during insertion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy, Colon Disease
Keywords
water exchange, water jet channel colonoscopy, colonoscopy, cecal insertion time, adenoma detection rate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of 120 patients were allocated into one of two groups by computerized randomization. In group A (Two-channel group), clear water was infused through the water jet channel and dirty water was sucked form the accessy channel. In group B (One-channel group), water exchange was done by using the accessory channel for both infusing and suctioning of water.
Masking
None (Open Label)
Masking Description
These codes were contained in pre-arranged opaque envelopes, which were opened immediately before insertion of the colonoscope.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Two-channel group
Arm Type
Experimental
Arm Description
The colonoscopy was done with the new designed colonoscopy that integrated a separate water jet channel for infusing water. The dirty water was removed through other accessory channel.
Arm Title
One-channel group
Arm Type
Active Comparator
Arm Description
The colonoscopy was done with the traditional colonoscopy. Water exchange was done by using the accessory channel for both infusing and suctioning of water.
Intervention Type
Device
Intervention Name(s)
Water jet channel
Intervention Description
The separate water jet channel was used for infusing water.
Intervention Type
Device
Intervention Name(s)
Accessory channel
Intervention Description
The accessory channel was used for infusing and/or suctioning water
Primary Outcome Measure Information:
Title
cecal insertion time
Description
Cecal insertion time was defined as the time from insertion into the rectum to the time when the colonoscope tip passed to a point proximal to the ileocecal valve so that the base of cecum was visible.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Underwent fully sedative colonoscopy with WE method in the outpatient department Exclusion Criteria: Age < 18 years old or > 80 years old Without standard colon preparation Allergy to meperidine or propofol With a history of partial colectomy Refusal to provide written informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Hsi Hsieh
Organizational Affiliation
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
City
Taipei
ZIP/Postal Code
62247
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32203986
Citation
Tseng CW, Koo M, Hsieh YH. Cecal intubation time between the use of one-channel and two-channel water exchange colonoscopy: A randomized controlled trial. J Gastroenterol Hepatol. 2020 Sep;35(9):1562-1569. doi: 10.1111/jgh.15043. Epub 2020 Apr 6.
Results Reference
derived

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The efficacy of the Integrated Water Jet Channel Colonoscopy in Water Exchange Method

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