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

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ClinicalTrials.gov Identifier: NCT03279705
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Chih-wei Tseng, Dalin Tzu Chi General Hospital

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.

Condition or disease Intervention/treatment Phase
Colonoscopy Colon Disease Device: Water jet channel Device: Accessory channel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Primary Purpose: Diagnostic
Official Title: Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279705


Locations
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Taiwan
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taipei, Taiwan, 62247
Sponsors and Collaborators
Chih-wei Tseng
Investigators
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Study Director: Yu-Hsi Hsieh Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chih-wei Tseng, Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT03279705    
Other Study ID Numbers: DalinTCGH
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chih-wei Tseng, Dalin Tzu Chi General Hospital:
water exchange
water jet channel colonoscopy
colonoscopy
cecal insertion time
adenoma detection rate
Additional relevant MeSH terms:
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Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases