Carbon Dioxide During Screening Unsedated Colonoscopy

NCT ID: NCT01461564

Last Updated: 2014-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-06-30

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.

Conditions

Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Carbon dioxide

Patients insufflated with carbon dioxide during screening colonoscopy

Group Type: EXPERIMENTAL

Colonoscopy

Intervention Type: PROCEDURE

Screening colonoscopy

Air

Patients insufflated with air during screening colonoscopy

Group Type: ACTIVE_COMPARATOR

Colonoscopy

Intervention Type: PROCEDURE

Screening colonoscopy

Interventions

Colonoscopy

Screening colonoscopy

Intervention Type: PROCEDURE

Other Intervention Names

Endoscopy; Flexible endoscopy

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Radoslaw Pach

Assisstant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miroslaw Szura, MD PhD

Role: STUDY_DIRECTOR

I Dept of General, Oncological and GI Surgery Jagiellonian University

Radoslaw Pach, MD PhD

Role: PRINCIPAL_INVESTIGATOR

I Dept of General, Oncological and GI Surgery Jagiellonian University

Andrzej Matyja, MD PhD

Role: STUDY_CHAIR

I Dept of General, Oncological and GI Surgery Jagiellonian University

Locations

1st Department of General, Oncological and Gastrointestinal Surgery, Jagiellonian University

Krakow, Malopolska, Poland

Countries

Poland

References

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.

Reference Type: RESULT

PMID: 24915135 (View on PubMed)

Other Identifiers

Cracow CO2 Trial

Identifier Type: -

Identifier Source: org_study_id