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Clinical Trials/NCT01461564
NCT01461564
Completed
Phase 4

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

Jagiellonian University1 site in 1 country200 target enrollmentJanuary 2010
ConditionsPolyps

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Polyps
Sponsor
Jagiellonian University
Enrollment
200
Locations
1
Primary Endpoint
duration of procedure
Status
Completed
Last Updated
11 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
June 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jagiellonian University
Responsible Party
Principal Investigator
Principal Investigator

Radoslaw Pach

Assisstant Professor

Jagiellonian University

Eligibility 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

Outcomes

Primary Outcomes

duration of procedure

Time Frame: 1 hour

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

Secondary Outcomes

  • coecal intubation time(1 hour)
  • pain immediately after the procedure(1 min)
  • pain 15 minutes after colonoscopy(15 min)
  • complication rate(24 hours)

Study Sites (1)

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