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

NCT03279705 | Completed

• 1 other identifier: DalinTCGH
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy; Colon Disease

Keywords

water exchange; water jet channel colonoscopy; colonoscopy; cecal insertion time; adenoma detection rate

Outcome Measures

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.

  2 hours

Study Arms (2)

Two-channel group

EXPERIMENTAL

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

One-channel group

ACTIVE COMPARATOR

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

Water jet channel DEVICE

The separate water jet channel was used for infusing water.

Two-channel group

Accessory channel DEVICE

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

One-channel group; Two-channel group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chih-wei Tseng: lead

Study Sites (1)

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taipei, 62247, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 32203986 DERIVED

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Yu-Hsi Hsieh

  Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: These codes were contained in pre-arranged opaque envelopes, which were opened immediately before insertion of the colonoscope.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Division of Gastroenterology, Department of Internal Medicine

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: September 12, 2017
• Study Start: May 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)