Carbon Dioxide During Screening Unsedated Colonoscopy

Phase 4

Completed

• Conditions: Polyps
• Interventions: Procedure: Colonoscopy

• Registration Number: NCT01461564
• Lead Sponsor: Jagiellonian University

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-12
• Study Completion: 2011-06
• Study First Submitted: 2011-10-26
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-28
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-15
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbon dioxide	Colonoscopy	Patients insufflated with carbon dioxide during screening colonoscopy
Air	Colonoscopy	Patients insufflated with air during screening colonoscopy

Primary Outcome Measures

Name	Time	Method
duration of procedure	1 hour	Time from introduction of a colonoscope to removal of the colonoscope.

Secondary Outcome Measures

Name	Time	Method
pain immediately after the procedure	1 min	Pain assessed by VAS scale immediately after colonoscopy
pain 15 minutes after colonoscopy	15 min	Pain assessed by VAS scale 15 minutes after colonoscopy
coecal intubation time	1 hour	Time from introduction of a colonoscope to intubation of the coecumo
complication rate	24 hours	any compication of screening colonoscopy

Trial Locations

Locations (1)

1st Department of General, Oncological and Gastrointestinal Surgery, Jagiellonian University; 🇵🇱 Cracow, Malopolska, Poland