Carbon Dioxide During Screening Unsedated Colonoscopy

NCT01461564 | Completed Phase 4

• 1 other identifier: Cracow CO2 Trial
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Polyps

Keywords

screening; colonoscopy; carbon dioxide; air; pain score; complications

Outcome Measures

Primary Outcomes (1)

• duration of procedure

  Time from introduction of a colonoscope to removal of the colonoscope.

  1 hour

Secondary Outcomes (4)

• coecal intubation time

  1 hour

• pain immediately after the procedure

  1 min

• pain 15 minutes after colonoscopy

  15 min

• complication rate

  24 hours

Study Arms (2)

Carbon dioxide

EXPERIMENTAL

Patients insufflated with carbon dioxide during screening colonoscopy

Procedure: Colonoscopy

Air

ACTIVE COMPARATOR

Patients insufflated with air during screening colonoscopy

Procedure: Colonoscopy

Interventions

Colonoscopy PROCEDURE

Screening colonoscopy

Also known as: Endoscopy, Flexible endoscopy

Air; Carbon dioxide

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 50 yo and more
• no previous large bowel operations
• no previous colonoscopy
• informed consent

You may not qualify if:

• previous colonoscopy
• previous large bowel operations/ polypectomies

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

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

Krakow, Malopolska, 31-501, Poland

Location

Related 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.

  PMID: 24915135 RESULT

MeSH Terms

Conditions

Polyps

Interventions

Colonoscopy; Endoscopy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Miroslaw Szura, MD PhD

  I Dept of General, Oncological and GI Surgery Jagiellonian University

  STUDY DIRECTOR

• Radoslaw Pach, MD PhD

  I Dept of General, Oncological and GI Surgery Jagiellonian University

  PRINCIPAL INVESTIGATOR

• Andrzej Matyja, MD PhD

  I Dept of General, Oncological and GI Surgery Jagiellonian University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: October 28, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: June 17, 2014

Record last verified: 2014-06

Locations

PL (1)