Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Polyps Procedure: Colonoscopy Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Randomized Clinical Trial to Compare Air Versus Carbon Dioxide in Screening Unsedated Colonoscopy.
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Carbon dioxide
Patients insufflated with carbon dioxide during screening colonoscopy
 Procedure: Colonoscopy
Screening colonoscopy
Other Names:
  • Endoscopy
  • Flexible endoscopy
Active Comparator: Air
Patients insufflated with air during screening colonoscopy
 Procedure: Colonoscopy
Screening colonoscopy
Other Names:
  • Endoscopy
  • Flexible endoscopy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. duration of procedure [ Time Frame: 1 hour ]
    Time from introduction of a colonoscope to removal of the colonoscope.


Secondary Outcome Measures :
  1. coecal intubation time [ Time Frame: 1 hour ]
    Time from introduction of a colonoscope to intubation of the coecumo

  2. pain immediately after the procedure [ Time Frame: 1 min ]
    Pain assessed by VAS scale immediately after colonoscopy

  3. pain 15 minutes after colonoscopy [ Time Frame: 15 min ]
    Pain assessed by VAS scale 15 minutes after colonoscopy

  4. complication rate [ Time Frame: 24 hours ]
    any compication of screening colonoscopy


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01461564


Locations
Layout table for location information
Poland
1st Department of General, Oncological and Gastrointestinal Surgery, Jagiellonian University
Cracow, Malopolska, Poland, 31-501
Sponsors and Collaborators
Jagiellonian University
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Radoslaw Pach, Assisstant Professor, Jagiellonian University
ClinicalTrials.gov Identifier: NCT01461564    
Other Study ID Numbers: Cracow CO2 Trial
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: June 17, 2014
Last Verified: June 2014
Keywords provided by Radoslaw Pach, Jagiellonian University:
screening
colonoscopy
carbon dioxide
 air
pain score
complications