Water Exchange Versus Carbon Dioxide for Colonoscopy

February 11, 2014 updated by: Sorlandet Hospital HF

Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial

Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of colonoscopy involving the use of water as the sole modality to aid colonoscope insertion, water exchange, has been described in recent research papers to decrease patient discomfort and pain, and to reduce the need for sedation during colonoscopy when compared with standard air insufflation. Carbon dioxide insufflation has been described to decrease patient discomfort after colonoscopy. No randomized trial has so far compared the use of water exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients undergoing screening colonoscopy in two centers in Norway, one center in Poland and one center in The Netherlands will be enrolled and randomized to examination of either of the two methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Single blinded randomized controlled trial.

Study Type

Interventional

Enrollment (Actual)

473

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

  • Norway
      • Arendal, Norway
        • Sorlandet hospital
      • Kristiansand, Norway, N-4604
        • Sorlandet hospital
  • Poland
      • Warsaw, Poland
        • The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for screening or polyp surveillance colonoscopy
  • Patients accepting sedation on demand

Exclusion Criteria:

  • Demand for sedation/analgesia before the start of the procedure
  • Previous partial or total colonic resection
  • Pregnancy
  • Unwilling/unable to provide 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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Water exchange
Colonoscopy with water exchange as the sole modality to reach the cecum. Carbon dioxide can be used in case of intubation failure with the test method.
Other: Water exchange colonoscopy
Water is infused and suctioned in a systematic fashion to obtain luminal view and for cleansing of the colon to facilitate colonoscope insertion. The carbon dioxide pump is turned off, only to be turned on during withdrawal from the cecum.
Other Names:
  • Water exchange
Active Comparator: Carbon dioxide insufflation
Carbon dioxide insufflation will be used in standard fashion to reach the cecum.
Other: Carbon dioxide insufflation
Carbon dioxide insufflation to obtain luminal view to facilitate colonoscope insertion, considered to be standard procedure.
Other Names:
  • Carbon dioxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during colonoscopy
Time Frame: 1 hour
Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during colonoscopy
Time Frame: 30 minutes
Patients will be asked to report pain during colonoscopy to an unblinded study assistant.
30 minutes
Cecal intubation rate
Time Frame: 1 hour
Cecal intubation rate is defined as successful completion of colonoscopy insertion. This will be analyzed on an intention-to-treat basis according to group allocation.
1 hour
Cecal intubation time
Time Frame: 1 hour
The time taken to complete insertion of the colonoscope.
1 hour
Adenoma detection rate
Time Frame: 1 hour
Detection of adenomas during each colonoscopy procedure
1 hour
Polyp detection rate
Time Frame: 1 hour
Detection of any colonic polyp, irrespective of histologic type, during each procedure.
1 hour
Dose of medication
Time Frame: 1 hour
Dose of sedative and analgesic medication needed to complete the colonoscopy.
1 hour

Collaborators and Investigators

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

Sponsor

Sorlandet Hospital HF

Collaborators

Erasmus Medical Center
South-Eastern Norway Regional Health Authority
Maria Sklodowska-Curie National Research Institute of Oncology

Investigators

  • Principal Investigator: Kjetil K Garborg, MD, Sorlandet Hospital HF Kristiansand, Norway

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

June 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 29, 2012

First Submitted That Met QC Criteria

July 3, 2012

First Posted (Estimate)

July 4, 2012

Study Record Updates

Last Update Posted (Estimate)

February 12, 2014

Last Update Submitted That Met QC Criteria

February 11, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WMCO2_KG

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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