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Trial record 6 of 1704 for:    CARBON DIOXIDE AND dioxide

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.
 
ClinicalTrials.gov Identifier: NCT01633333
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : February 12, 2014
Sponsor:
Collaborators:
South-Eastern Norway Regional Health Authority
Maria Sklodowska-Curie Institute - Oncology Center
Erasmus Medical Center
Information provided by (Responsible Party):
Sorlandet Hospital HF

Tracking Information
First Submitted Date  ICMJE June 29, 2012
First Posted Date  ICMJE July 4, 2012
Last Update Posted Date February 12, 2014
Study Start Date  ICMJE June 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2012)
Pain during colonoscopy [ Time Frame: 1 hour ]
Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01633333 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2013)
  • Pain during colonoscopy [ Time Frame: 30 minutes ]
    Patients will be asked to report pain during colonoscopy to an unblinded study assistant.
  • 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.
  • Cecal intubation time [ Time Frame: 1 hour ]
    The time taken to complete insertion of the colonoscope.
  • Adenoma detection rate [ Time Frame: 1 hour ]
    Detection of adenomas during each colonoscopy procedure
  • Polyp detection rate [ Time Frame: 1 hour ]
    Detection of any colonic polyp, irrespective of histologic type, during each procedure.
  • Dose of medication [ Time Frame: 1 hour ]
    Dose of sedative and analgesic medication needed to complete the colonoscopy.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2012)
  • Pain during colonoscopy [ Time Frame: 30 minutes ]
    Patients will be asked to report pain during colonoscpy to an unblinded study assistant.
  • Cecal intubation rate [ Time Frame: 1 hour ]
    Cecal intubation rate is defined as successfull 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 ]
    The time taken to complete insertion of the colonoscope.
  • Adenoma detection rate [ Time Frame: 1 hour ]
    Detection of adenomas during each colonoscopy procedure
  • Polyp detection rate [ Time Frame: 1 hour ]
    Detection of any colonic polyp, irrespective of histologic type, during each procedure.
  • Dose of medication [ Time Frame: 1 hour ]
    Dose of sedative and analgesic medication needed to complete the colonoscopy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Water Exchange Versus Carbon Dioxide for Colonoscopy
Official Title  ICMJE Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial
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.
Detailed Description Single blinded randomized controlled trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Condition  ICMJE
  • Colorectal Cancer
  • Colorectal Adenomas
  • Colorectal Polyps
  • Pain
Intervention  ICMJE
  • 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
  • Other: Carbon dioxide insufflation
    Carbon dioxide insufflation to obtain luminal view to facilitate colonoscope insertion, considered to be standard procedure.
    Other Name: Carbon dioxide
Study Arms  ICMJE
  • 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.
    Intervention: Other: Water exchange colonoscopy
  • Active Comparator: Carbon dioxide insufflation
    Carbon dioxide insufflation will be used in standard fashion to reach the cecum.
    Intervention: Other: Carbon dioxide insufflation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2014)
473
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2012)
500
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway,   Poland
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT01633333
Other Study ID Numbers  ICMJE WMCO2_KG
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sorlandet Hospital HF
Study Sponsor  ICMJE Sorlandet Hospital HF
Collaborators  ICMJE
  • South-Eastern Norway Regional Health Authority
  • Maria Sklodowska-Curie Institute - Oncology Center
  • Erasmus Medical Center
Investigators  ICMJE
Principal Investigator: Kjetil K Garborg, MD Sorlandet Hospital HF Kristiansand, Norway
PRS Account Sorlandet Hospital HF
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP