Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy

April 29, 2016 updated by: Yu-Hsi hsieh, Dalin Tzu Chi General Hospital

A Randomized, Controlled Trial Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy

This prospective, randomize, controlled trial will compared cap-assisted water exchange with water exchange in patients undergoing sedated colonoscopy. Investigators test the hypothesis that that cap-assisted water exchange is more efficient and causes a shorter insertion time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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
      • Chia-Yi, Taiwan, 622
        • Dalin Tzu Chi General Hospital

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing fully sedated colonoscopy performed by the investigators

Exclusion Criteria:

  • obstructive lesions of the colon
  • massive ascites
  • history of partial colectomy
  • 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: water exchange
The air was turned off at the beginning of colonoscopy. Water was infused and suctioned at the same time during insertion. The air was turned on when the colonoscope reached the cecum.
Procedure: water exchange
water was infused and suctioned at the same time during insertion of colonoscope
Experimental: cap-assisted water exchange
Cap was mounted to the tip of the colonoscope when water exchange was performed.
Procedure: water exchange
water was infused and suctioned at the same time during insertion of colonoscope
Device: cap-assisted water exchange
a transparent cap was mounted to the tip of colonoscopy when water exchange was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cecal intubation time
Time Frame: when the colonoscope reaches the cecum, an average of 14 minutes
when the colonoscope reaches the cecum, an average of 14 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose of propofol
Time Frame: The end of colonoscopy, an average of 14 minutes
The end of colonoscopy, an average of 14 minutes
adenoma detection rate
Time Frame: One week after colonoscopy
when histology analysis of the removed polyps are available
One week after colonoscopy

Collaborators and Investigators

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

Sponsor

Dalin Tzu Chi General Hospital

Investigators

  • Principal Investigator: Yu-Hsi Hsieh, MD, Dalin Tzu Chi Hospital. Tzu Chi medication 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

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Hsieh-2016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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