An interventional study of Water exchange colonoscopy and Carbon dioxide insufflation in Colorectal Cancer, Colorectal Adenomas and Colorectal Polyps, sponsored by Sorlandet Hospital HF. Completed at 3 sites in 2 countries. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-12.
Sponsored by Sorlandet Hospital HF · Not applicable, Interventional, and Screening
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.
Single blinded randomized controlled trial.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 473 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
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Exclusion Criteria:
Colonoscopy with water exchange as the sole modality to reach the cecum. Carbon dioxide can be used in case of intubation failure with the test method.
Other: Water exchange colonoscopy
Carbon dioxide insufflation will be used in standard fashion to reach the cecum.
Other: Carbon dioxide insufflation
Water is infused and suctioned in a systematic fashion to obtain luminal view and for cleansing of the colon to facilitate colonoscope insertion. The carbon dioxide pump is turned off, only to be turned on during withdrawal from the cecum.
Also known as: Water exchange
Carbon dioxide insufflation to obtain luminal view to facilitate colonoscope insertion, considered to be standard procedure.
Also known as: Carbon dioxide
Pain during colonoscopy
Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure.
Time frame: 1 hour
Pain during colonoscopy
Patients will be asked to report pain during colonoscopy to an unblinded study assistant.
Time frame: 30 minutes
Cecal intubation rate
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.
Time frame: 1 hour
Cecal intubation time
The time taken to complete insertion of the colonoscope.
Time frame: 1 hour
Adenoma detection rate
Detection of adenomas during each colonoscopy procedure
Time frame: 1 hour
Polyp detection rate
Detection of any colonic polyp, irrespective of histologic type, during each procedure.
Time frame: 1 hour
Dose of medication
Dose of sedative and analgesic medication needed to complete the colonoscopy.
Time frame: 1 hour
The record gives a start of Jun 2012, a primary completion of Dec 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Sorlandet Hospital HF