Carbon Dioxide During Screening Unsedated Colonoscopy

Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461564
• Other study ID #: Cracow CO2 Trial
• Status: Completed
• Phase: Phase 4
• First received: October 26, 2011
• Last updated: June 15, 2014
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2014
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Related Conditions & MeSH terms

• Polyps

Intervention

Procedure:
• Colonoscopy
Screening colonoscopy

Locations

Country	Name	City	State
Poland	1st Department of General, Oncological and Gastrointestinal Surgery, Jagiellonian University	Cracow	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Szura M, Pach R, Matyja A, Kulig J. Carbon dioxide insufflation during screening unsedated colonoscopy: a randomised clinical trial. Eur J Cancer Prev. 2015 Jan;24(1):37-43. doi: 10.1097/CEJ.0000000000000047. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of procedure	Time from introduction of a colonoscope to removal of the colonoscope.	1 hour	No
Secondary	coecal intubation time	Time from introduction of a colonoscope to intubation of the coecumo	1 hour	No
Secondary	pain immediately after the procedure	Pain assessed by VAS scale immediately after colonoscopy	1 min	No
Secondary	pain 15 minutes after colonoscopy	Pain assessed by VAS scale 15 minutes after colonoscopy	15 min	No
Secondary	complication rate	any compication of screening colonoscopy	24 hours	Yes