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

NCT ID: NCT03279705

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2019-10-01

Brief Summary

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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

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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.

Conditions

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Colonoscopy Colon Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

These codes were contained in pre-arranged opaque envelopes, which were opened immediately before insertion of the colonoscope.

Study Groups

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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.

Group Type EXPERIMENTAL

Water jet channel

Intervention Type DEVICE

The separate water jet channel was used for infusing water.

Accessory channel

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Accessory channel

Intervention Type DEVICE

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

Interventions

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Water jet channel

The separate water jet channel was used for infusing water.

Intervention Type DEVICE

Accessory channel

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chih-wei Tseng

OTHER

Sponsor Role lead

Responsible Party

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Chih-wei Tseng

Division of Gastroenterology, Department of Internal Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yu-Hsi Hsieh

Role: STUDY_DIRECTOR

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Locations

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Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 32203986 (View on PubMed)

Other Identifiers

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DalinTCGH

Identifier Type: -

Identifier Source: org_study_id

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