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Carbon Dioxide During Screening Unsedated Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radoslaw Pach, Jagiellonian University
ClinicalTrials.gov Identifier:
NCT01461564
First received: October 26, 2011
Last updated: October 27, 2011
Last verified: October 2011
History of Changes

October 26, 2011
October 27, 2011
January 2010
December 2010   (final data collection date for primary outcome measure)
duration of procedure [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Time from introduction of a colonoscope to removal of the colonoscope.
Same as current
Complete list of historical versions of study NCT01461564 on ClinicalTrials.gov Archive Site
  • coecal intubation time [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Time from introduction of a colonoscope to intubation of the coecumo
  • pain immediately after the procedure [ Time Frame: 1 min ] [ Designated as safety issue: No ]
    Pain assessed by VAS scale immediately after colonoscopy
  • pain 15 minutes after colonoscopy [ Time Frame: 15 min ] [ Designated as safety issue: No ]
    Pain assessed by VAS scale 15 minutes after colonoscopy
  • complication rate [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    any compication of screening colonoscopy
Same as current
Not Provided
Not Provided
 
Carbon Dioxide During Screening Unsedated Colonoscopy
Randomized Clinical Trial to Compare Air Versus Carbon Dioxide in Screening Unsedated Colonoscopy.

Colonoscopy is currently most effective procedure used for detecting colon cancer especially in the early stages. Screening colonoscopies are performed in the symptom-free patients at risk of familial colon cancer. During colonoscopy air commonly used to insufflate the bowel may be retained after the procedure causing pain and discomfort to the patients. One of the methods used to reduce pain and discomfort is insufflation of carbon dioxide (CO2) instead of air during colonoscopy.

Aim of the study is evaluation of the use of carbon dioxide insufflation during colonoscopy.

The study was conducted in 200 consecutive patients undergoing screening colonoscopies for the detection of early colon cancer. The examinations were performed with Olympus 165 colonoscopes by seven experienced endoscopists, each of whom performed alone about over 2000 colonoscopies. The patients were randomly assigned to Group I and II with either air or carbon dioxide insufflation. Both study groups were matched by sex, age, duration of the procedure, and BMI. The authors compared for the duration of the procedure, coecal intubation time, complication rate, pulse rates immediately after the procedure, 15 minutes after, and subjective pain evaluation on a Visual Analogue Scale.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Polyps
Procedure: Colonoscopy
Screening colonoscopy
Other Names:
  • Endoscopy
  • Flexible endoscopy
  • Experimental: Carbon dioxide
    Patients insufflated with carbon dioxide during screening colonoscopy
    Intervention: Procedure: Colonoscopy
  • Active Comparator: Air
    Patients insufflated with air during screening colonoscopy
    Intervention: Procedure: Colonoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 50 yo and more
  • no previous large bowel operations
  • no previous colonoscopy
  • informed consent

Exclusion Criteria:

  • previous colonoscopy
  • previous large bowel operations/ polypectomies
Both
50 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01461564
Cracow CO2 Trial
No
Radoslaw Pach, Jagiellonian University
Jagiellonian University
Not Provided
Study Director: Miroslaw Szura, MD PhD I Dept of General, Oncological and GI Surgery Jagiellonian University
Principal Investigator: Radoslaw Pach, MD PhD I Dept of General, Oncological and GI Surgery Jagiellonian University
Study Chair: Andrzej Matyja, MD PhD I Dept of General, Oncological and GI Surgery Jagiellonian University
Jagiellonian University
October 2011

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