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: June 15, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Polyps
Procedure: Colonoscopy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Randomized Clinical Trial to Compare Air Versus Carbon Dioxide in Screening Unsedated Colonoscopy.

Resource links provided by NLM:


Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • duration of procedure [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Time from introduction of a colonoscope to removal of the colonoscope.


Secondary Outcome Measures:
  • 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


Enrollment: 200
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
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
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: NCT01461564

Locations
Poland
1st Department of General, Oncological and Gastrointestinal Surgery, Jagiellonian University
Cracow, Malopolska, Poland, 31-501
Sponsors and Collaborators
Jagiellonian University
Investigators
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

Publications:
Responsible Party: Radoslaw Pach, Assisstant Professor, Jagiellonian University
ClinicalTrials.gov Identifier: NCT01461564     History of Changes
Other Study ID Numbers: Cracow CO2 Trial
Study First Received: October 26, 2011
Last Updated: June 15, 2014
Health Authority: Poland: Ministry of Health

Keywords provided by Jagiellonian University:
screening
colonoscopy
carbon dioxide
air
pain score
complications

ClinicalTrials.gov processed this record on September 18, 2014