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Carbon Dioxide During Screening Unsedated Colonoscopy

J

Jagiellonian University

Status and phase

Completed
Phase 4

Conditions

Polyps

Treatments

Procedure: Colonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT01461564
Cracow CO2 Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

50 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Carbon dioxide
Experimental group
Description:
Patients insufflated with carbon dioxide during screening colonoscopy
Treatment:
Procedure: Colonoscopy
Air
Active Comparator group
Description:
Patients insufflated with air during screening colonoscopy
Treatment:
Procedure: Colonoscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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