Carbon Dioxide During Screening Unsedated Colonoscopy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polyps

Intervention / Treatment
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* Procedure: Colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbon dioxide<br>Patients insufflated with carbon dioxide during screening colonoscopy | Procedure: Colonoscopy<br>* Screening colonoscopy<br>* Other names: Flexible endoscopy;|
| Active Comparator: Air<br>Patients insufflated with air during screening colonoscopy | Procedure: Colonoscopy<br>* Screening colonoscopy<br>* Other names: Flexible endoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of procedure | Time from introduction of a colonoscope to removal of the colonoscope. | 1 hour | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening, colonoscopy, carbon dioxide, air, pain score, complications