Water Exchange Versus Carbon Dioxide for Colonoscopy

Study Overview
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Brief Summary
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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
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Single blinded randomized controlled trial.

Official Title
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Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial

Conditions
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Colorectal Cancer, Colorectal Adenomas, Colorectal Polyps, Pain

Intervention / Treatment
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* Other: Water exchange colonoscopy
* Other: Carbon dioxide insufflation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water exchange<br>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<br>* 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.<br>* Other names: Water exchange;|
| Active Comparator: Carbon dioxide insufflation<br>Carbon dioxide insufflation will be used in standard fashion to reach the cecum. | Other: Carbon dioxide insufflation<br>* Carbon dioxide insufflation to obtain luminal view to facilitate colonoscope insertion, considered to be standard procedure.<br>* Other names: Carbon dioxide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during colonoscopy | Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during colonoscopy | Patients will be asked to report pain during colonoscopy to an unblinded study assistant. | 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. | 1 hour | 
| Cecal intubation time | The time taken to complete insertion of the colonoscope. | 1 hour | 
| Adenoma detection rate | Detection of adenomas during each colonoscopy procedure | 1 hour | 
| Polyp detection rate | Detection of any colonic polyp, irrespective of histologic type, during each procedure. | 1 hour | 
| Dose of medication | Dose of sedative and analgesic medication needed to complete the colonoscopy. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Colorectal cancer, Colorectal adenomas, Pain