Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Carbon Dioxide During Screening Unsedated 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: NCT01461564
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Radoslaw Pach, Jagiellonian University

Tracking Information
First Submitted Date  ICMJE October 26, 2011
First Posted Date  ICMJE October 28, 2011
Last Update Posted Date June 17, 2014
Study Start Date  ICMJE January 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2011)
duration of procedure [ Time Frame: 1 hour ]
Time from introduction of a colonoscope to removal of the colonoscope.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01461564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2011)
  • coecal intubation time [ Time Frame: 1 hour ]
    Time from introduction of a colonoscope to intubation of the coecumo
  • pain immediately after the procedure [ Time Frame: 1 min ]
    Pain assessed by VAS scale immediately after colonoscopy
  • pain 15 minutes after colonoscopy [ Time Frame: 15 min ]
    Pain assessed by VAS scale 15 minutes after colonoscopy
  • complication rate [ Time Frame: 24 hours ]
    any compication of screening colonoscopy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carbon Dioxide During Screening Unsedated Colonoscopy
Official Title  ICMJE Randomized Clinical Trial to Compare Air Versus Carbon Dioxide in Screening Unsedated Colonoscopy.
Brief Summary

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.

Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Condition  ICMJE Polyps
Intervention  ICMJE Procedure: Colonoscopy
Screening colonoscopy
Other Names:
  • Endoscopy
  • Flexible endoscopy
Study Arms  ICMJE
  • 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
Publications * Szura M, Pach R, Matyja A, Kulig J. Carbon dioxide insufflation during screening unsedated colonoscopy: a randomised clinical trial. Eur J Cancer Prev. 2015 Jan;24(1):37-43. doi: 10.1097/CEJ.0000000000000047.

*   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: October 27, 2011)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01461564
Other Study ID Numbers  ICMJE Cracow CO2 Trial
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radoslaw Pach, Jagiellonian University
Study Sponsor  ICMJE Jagiellonian University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Jagiellonian University
Verification Date June 2014

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