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Randomized Clinical Trial to Compare Air Versus Carbon Dioxide in Screening Unsedated Colonoscopy.

Phase 4
50 Years
65 Years
Not Enrolling

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Trial Information

Randomized Clinical Trial to Compare Air Versus Carbon Dioxide in Screening Unsedated 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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Outcome Measure:

duration of procedure

Outcome Description:

Time from introduction of a colonoscope to removal of the colonoscope.

Outcome Time Frame:

1 hour

Safety Issue:


Principal Investigator

Miroslaw Szura, MD PhD

Investigator Role:

Study Director

Investigator Affiliation:

I Dept of General, Oncological and GI Surgery Jagiellonian University


Poland: Ministry of Health

Study ID:

Cracow CO2 Trial



Start Date:

January 2010

Completion Date:

June 2011

Related Keywords:

  • Polyps
  • screening
  • colonoscopy
  • carbon dioxide
  • air
  • pain score
  • complications