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CompletedNCT03279705Updated Oct 29, 2019

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

An interventional study of Water jet channel and Accessory channel in Colonoscopy and Colon Disease, sponsored by Chih-wei Tseng. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-29.

Sponsored by Chih-wei Tseng · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colonoscopy
  • Colon Disease

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Keywords

  • water exchange
  • water jet channel colonoscopy
  • colonoscopy
  • cecal insertion time
  • adenoma detection rate
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Two-channel group

    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.

    Device: Water jet channel · Device: Accessory channel

  • Active comparator
    One-channel group

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

    Device: Accessory channel

Interventions

  • DeviceWater jet channel

    The separate water jet channel was used for infusing water.

  • DeviceAccessory channel

    The accessory channel was used for infusing and/or suctioning water

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 hours

06

Study locations

1 site
  • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
    Taipei, 62247, Taiwan
07

References and documents

Publications

  • 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. PubMed 32203986 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03279705
Lead sponsor
Chih-wei Tseng
Responsible party
Chih-wei Tseng (Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi General Hospital) — Sponsor-investigator
First posted
Sep 12, 2017
Start date
May 1, 2017
Primary completion
Apr 1, 2019
Completion
Oct 1, 2019
Last update
Oct 29, 2019

Study contacts

Yu-Hsi Hsieh
study director · Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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