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Water Exchange Versus Carbon Dioxide for Colonoscopy

This study has been completed.
Sponsor:
Collaborators:
South-Eastern Norway Regional Health Authority
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Erasmus Medical Center
Information provided by (Responsible Party):
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT01633333
First received: June 29, 2012
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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 Intervention
Colorectal Cancer
Colorectal Adenomas
Colorectal Polyps
Pain
Other: Water exchange colonoscopy
Other: Carbon dioxide insufflation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Pain during colonoscopy [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure.


Secondary Outcome Measures:
  • Pain during colonoscopy [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Patients will be asked to report pain during colonoscopy to an unblinded study assistant.

  • Cecal intubation rate [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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.

  • Cecal intubation time [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    The time taken to complete insertion of the colonoscope.

  • Adenoma detection rate [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Detection of adenomas during each colonoscopy procedure

  • Polyp detection rate [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Detection of any colonic polyp, irrespective of histologic type, during each procedure.

  • Dose of medication [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Dose of sedative and analgesic medication needed to complete the colonoscopy.


Enrollment: 473
Study Start Date: June 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Single blinded randomized controlled trial.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633333

Locations
Norway
Sorlandet Hospital
Arendal, Norway
Sorlandet Hospital
Kristiansand, Norway, N-4604
Poland
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 Memorial Cancer Center, Institute of Oncology
Erasmus Medical Center
Investigators
Principal Investigator: Kjetil K Garborg, MD Sorlandet Hospital HF Kristiansand, Norway
  More Information

Additional Information:
Publications:

Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT01633333     History of Changes
Other Study ID Numbers: WMCO2_KG
Study First Received: June 29, 2012
Last Updated: February 11, 2014
Health Authority: Norway: Regional Ethics Commitee
Poland: Ethics Committee

Keywords provided by Sorlandet Hospital HF:
Colonoscopy
Colorectal cancer
Colorectal adenomas
Pain

Additional relevant MeSH terms:
Adenoma
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Rectal Diseases

ClinicalTrials.gov processed this record on November 25, 2014