Carbon Dioxide During Screening Unsedated Colonoscopy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01461564|
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : June 17, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Polyps||Procedure: Colonoscopy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Clinical Trial to Compare Air Versus Carbon Dioxide in Screening Unsedated Colonoscopy.|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||June 2011|
Experimental: Carbon dioxide
Patients insufflated with carbon dioxide during screening colonoscopy
Active Comparator: Air
Patients insufflated with air during screening colonoscopy
- duration of procedure [ Time Frame: 1 hour ]Time from introduction of a colonoscope to removal of the colonoscope.
- coecal intubation time [ Time Frame: 1 hour ]Time from introduction of a colonoscope to intubation of the coecumo
- pain immediately after the procedure [ Time Frame: 1 min ]Pain assessed by VAS scale immediately after colonoscopy
- pain 15 minutes after colonoscopy [ Time Frame: 15 min ]Pain assessed by VAS scale 15 minutes after colonoscopy
- complication rate [ Time Frame: 24 hours ]any compication of screening colonoscopy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|