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OpenTrials
Completed

NCT Number: NCT01461564

Carbon Dioxide During 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.

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Key information

Conditions

Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

1st Department of General, Oncological and Gastrointestinal Surgery, Jagiellonian University

Cracow, Malopolska, 31-501, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colonoscopy

Procedure

Screening colonoscopy

Other names: Endoscopy, Flexible endoscopy

Primary outcomes

  1. duration of procedure

    Time frame: 1 hour

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Oct 28, 2011
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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