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Water Exchange Versus Carbon Dioxide for Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01633333
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : February 12, 2014
South-Eastern Norway Regional Health Authority
Maria Sklodowska-Curie National Research Institute of Oncology
Erasmus Medical Center
Information provided by (Responsible Party):
Sorlandet Hospital HF

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colorectal Adenomas Colorectal Polyps Pain Other: Water exchange colonoscopy Other: Carbon dioxide insufflation Not Applicable

Detailed Description:
Single blinded randomized controlled trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 473 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial
Study Start Date : June 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

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 Name: 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 Name: Carbon dioxide

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

Secondary Outcome Measures :
  1. Pain during colonoscopy [ Time Frame: 30 minutes ]
    Patients will be asked to report pain during colonoscopy to an unblinded study assistant.

  2. 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.

  3. Cecal intubation time [ Time Frame: 1 hour ]
    The time taken to complete insertion of the colonoscope.

  4. Adenoma detection rate [ Time Frame: 1 hour ]
    Detection of adenomas during each colonoscopy procedure

  5. Polyp detection rate [ Time Frame: 1 hour ]
    Detection of any colonic polyp, irrespective of histologic type, during each procedure.

  6. Dose of medication [ Time Frame: 1 hour ]
    Dose of sedative and analgesic medication needed to complete the colonoscopy.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01633333

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Sorlandet Hospital
Arendal, Norway
Sorlandet Hospital
Kristiansand, Norway, N-4604
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Poland
Sponsors and Collaborators
Sorlandet Hospital HF
South-Eastern Norway Regional Health Authority
Maria Sklodowska-Curie National Research Institute of Oncology
Erasmus Medical Center
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Principal Investigator: Kjetil K Garborg, MD Sorlandet Hospital HF Kristiansand, Norway

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sorlandet Hospital HF Identifier: NCT01633333    
Other Study ID Numbers: WMCO2_KG
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014
Keywords provided by Sorlandet Hospital HF:
Colorectal cancer
Colorectal adenomas
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type