Clinical trial NCT01633333: Water Exchange Versus Carbon Dioxide for Colonoscopy
Official title: Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colorectal Adenomas
Colorectal Polyps
Pain
Keywords: Colonoscopy
Colorectal cancer
Colorectal adenomas
Pain
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: South-Eastern Norway Regional Health Authority
name: Maria Sklodowska-Curie National Research Institute of Oncology
name: Erasmus Medical Center
First posted: 2012-07-04
Enrollment: 473
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain during colonoscopy
timeFrame: 1 hour
Secondary outcomes:
measure: Pain during colonoscopy
timeFrame: 30 minutes
measure: Cecal intubation rate
timeFrame: 1 hour
measure: Cecal intubation time
timeFrame: 1 hour
measure: Adenoma detection rate
timeFrame: 1 hour
measure: Polyp detection rate
timeFrame: 1 hour
measure: Dose of medication
timeFrame: 1 hour
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Sorlandet Hospital
city: Kristiansand
country: Norway
facility: Sorlandet Hospital
city: Warsaw
country: Poland
facility: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Study officials:
affiliation: Sorlandet Hospital HF Kristiansand, Norway
name: Kjetil K Garborg, MD
role: PRINCIPAL_INVESTIGATOR
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