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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
|Official Title:||Randomized Clinical Trial to Compare Air Versus Carbon Dioxide in Screening Unsedated Colonoscopy.|
- duration of procedure [ Time Frame: 1 hour ] [ Designated as safety issue: No ]Time from introduction of a colonoscope to removal of the colonoscope.
- coecal intubation time [ Time Frame: 1 hour ] [ Designated as safety issue: No ]Time from introduction of a colonoscope to intubation of the coecumo
- pain immediately after the procedure [ Time Frame: 1 min ] [ Designated as safety issue: No ]Pain assessed by VAS scale immediately after colonoscopy
- pain 15 minutes after colonoscopy [ Time Frame: 15 min ] [ Designated as safety issue: No ]Pain assessed by VAS scale 15 minutes after colonoscopy
- complication rate [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]any compication of screening colonoscopy
|Study Start Date:||January 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: Carbon dioxide
Patients insufflated with carbon dioxide during screening colonoscopy
Active Comparator: Air
Patients insufflated with air during screening colonoscopy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461564
|1st Department of General, Oncological and Gastrointestinal Surgery, Jagiellonian University|
|Cracow, Malopolska, Poland, 31-501|
|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|