Water Exchange Versus Carbon Dioxide for Colonoscopy

Not Applicable

Completed

• Conditions: Colorectal Adenomas; Colorectal Polyps; Pain; Colorectal Cancer

• Registration Number: NCT01633333
• Lead Sponsor: Sorlandet Hospital HF

Brief Summary

Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of colonoscopy involving the use of water as the sole modality to aid colonoscope insertion, water exchange, has been described in recent research papers to decrease patient discomfort and pain, and to reduce the need for sedation during colonoscopy when compared with standard air insufflation. Carbon dioxide insufflation has been described to decrease patient discomfort after colonoscopy. No randomized trial has so far compared the use of water exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients undergoing screening colonoscopy in two centers in Norway, one center in Poland and one center in The Netherlands will be enrolled and randomized to examination of either of the two methods.

Detailed Description

Single blinded randomized controlled trial.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-29
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-04
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 473

Inclusion Criteria

• Patients scheduled for screening or polyp surveillance colonoscopy
• Patients accepting sedation on demand

Exclusion Criteria

• Demand for sedation/analgesia before the start of the procedure
• Previous partial or total colonic resection
• Pregnancy
• Unwilling/unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain during colonoscopy	1 hour	Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure.

Secondary Outcome Measures

Name	Time	Method
Pain during colonoscopy	30 minutes	Patients will be asked to report pain during colonoscopy to an unblinded study assistant.
Cecal intubation rate	1 hour	Cecal intubation rate is defined as successful completion of colonoscopy insertion. This will be analyzed on an intention-to-treat basis according to group allocation.
Cecal intubation time	1 hour	The time taken to complete insertion of the colonoscope.
Adenoma detection rate	1 hour	Detection of adenomas during each colonoscopy procedure
Polyp detection rate	1 hour	Detection of any colonic polyp, irrespective of histologic type, during each procedure.
Dose of medication	1 hour	Dose of sedative and analgesic medication needed to complete the colonoscopy.

Trial Locations

Locations (2)

Sorlandet Hospital; 🇳🇴 Kristiansand, Norway

The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology; 🇵🇱 Warsaw, Poland