Carbon Dioxide During Screening Unsedated Colonoscopy

June 15, 2014 updated by: Radoslaw Pach, Jagiellonian University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Malopolska
      • Cracow, Malopolska, Poland, 31-501
        • 1st Department of General, Oncological and Gastrointestinal Surgery, Jagiellonian University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of procedure
Time Frame: 1 hour
Time from introduction of a colonoscope to removal of the colonoscope.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
coecal intubation time
Time Frame: 1 hour
Time from introduction of a colonoscope to intubation of the coecumo
1 hour
pain immediately after the procedure
Time Frame: 1 min
Pain assessed by VAS scale immediately after colonoscopy
1 min
pain 15 minutes after colonoscopy
Time Frame: 15 min
Pain assessed by VAS scale 15 minutes after colonoscopy
15 min
complication rate
Time Frame: 24 hours
any compication of screening colonoscopy
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 26, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Estimate)

June 17, 2014

Last Update Submitted That Met QC Criteria

June 15, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Cracow CO2 Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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