Clinical trial NCT01461564: Carbon Dioxide During Screening Unsedated Colonoscopy
Official title: Randomized Clinical Trial to Compare Air Versus Carbon Dioxide in Screening Unsedated Colonoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polyps
Keywords: screening
colonoscopy
carbon dioxide
air
pain score
complications
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2011-10-28
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: duration of procedure
timeFrame: 1 hour
Secondary outcomes:
measure: coecal intubation time
timeFrame: 1 hour
measure: pain immediately after the procedure
timeFrame: 1 min
measure: pain 15 minutes after colonoscopy
timeFrame: 15 min
measure: complication rate
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cracow
country: Poland
facility: 1st Department of General, Oncological and Gastrointestinal Surgery, Jagiellonian University
state: Malopolska
Study officials:
affiliation: I Dept of General, Oncological and GI Surgery Jagiellonian University
name: Miroslaw Szura, MD PhD
role: STUDY_DIRECTOR
affiliation: I Dept of General, Oncological and GI Surgery Jagiellonian University
name: Radoslaw Pach, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: I Dept of General, Oncological and GI Surgery Jagiellonian University
name: Andrzej Matyja, MD PhD
role: STUDY_CHAIR
References:
citation: 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.