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CompletedNCT01461564Updated Jun 17, 2014

Carbon Dioxide During Screening Unsedated Colonoscopy

A Phase 4 interventional study of Colonoscopy in Polyps, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-06-17.

Sponsored by Jagiellonian University · Phase 4, Interventional, and Screening

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
50 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Polyps

Keywords

  • screening
  • colonoscopy
  • carbon dioxide
  • air
  • pain score
  • complications
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In context

Lead sponsor

Jagiellonian University is the lead sponsor of 156 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age 50 yo and more
  • no previous large bowel operations
  • no previous colonoscopy
  • informed consent

Exclusion criteria

Exclusion Criteria:

  • previous colonoscopy
  • previous large bowel operations/ polypectomies
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Study design

Phase
Phase 4
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Carbon dioxide

    Patients insufflated with carbon dioxide during screening colonoscopy

    Procedure: Colonoscopy

  • Active comparator
    Air

    Patients insufflated with air during screening colonoscopy

    Procedure: Colonoscopy

Interventions

  • ProcedureColonoscopy

    Screening colonoscopy

    Also known as: Endoscopy, Flexible endoscopy

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What researchers measure

Primary outcomes

  1. duration of procedure

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

    Time frame: 1 hour

Secondary outcomes

  1. coecal intubation time

    Time from introduction of a colonoscope to intubation of the coecumo

    Time frame: 1 hour

  2. pain immediately after the procedure

    Pain assessed by VAS scale immediately after colonoscopy

    Time frame: 1 min

  3. pain 15 minutes after colonoscopy

    Pain assessed by VAS scale 15 minutes after colonoscopy

    Time frame: 15 min

  4. complication rate

    any compication of screening colonoscopy

    Time frame: 24 hours

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Study locations

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

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. PubMed 24915135 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01461564
Lead sponsor
Jagiellonian University
Responsible party
Radoslaw Pach (Assisstant Professor, Jagiellonian University) — Principal investigator
First posted
Oct 28, 2011
Start date
Jan 2010
Primary completion
Dec 2010
Completion
Jun 2011
Last update
Jun 17, 2014

Study contacts

Miroslaw Szura, MD PhD
study director · I Dept of General, Oncological and GI Surgery Jagiellonian University
Radoslaw Pach, MD PhD
principal investigator · I Dept of General, Oncological and GI Surgery Jagiellonian University
Andrzej Matyja, MD PhD
study chair · I Dept of General, Oncological and GI Surgery Jagiellonian University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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