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

October 25, 2019 updated by: Chih-wei Tseng

Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
The separate water jet channel was used for infusing water.
Device: Accessory channel
The accessory channel was used for infusing and/or suctioning water
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
The accessory channel was used for infusing and/or suctioning water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cecal insertion time
Time Frame: 2 hours
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.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chih-wei Tseng

Investigators

  • Study Director: Yu-Hsi Hsieh, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

September 10, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DalinTCGH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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