Water Exchange Versus Carbon Dioxide for Colonoscopy
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|ClinicalTrials.gov Identifier: NCT01633333|
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : February 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Colorectal Adenomas Colorectal Polyps Pain||Other: Water exchange colonoscopy Other: Carbon dioxide insufflation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||473 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Water exchange
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
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.
Other Name: Water exchange
Active Comparator: Carbon dioxide insufflation
Carbon dioxide insufflation will be used in standard fashion to reach the cecum.
Other: Carbon dioxide insufflation
Carbon dioxide insufflation to obtain luminal view to facilitate colonoscope insertion, considered to be standard procedure.
Other Name: Carbon dioxide
- Pain during colonoscopy [ Time Frame: 1 hour ]Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure.
- Pain during colonoscopy [ Time Frame: 30 minutes ]Patients will be asked to report pain during colonoscopy to an unblinded study assistant.
- Cecal intubation rate [ Time Frame: 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 [ Time Frame: 1 hour ]The time taken to complete insertion of the colonoscope.
- Adenoma detection rate [ Time Frame: 1 hour ]Detection of adenomas during each colonoscopy procedure
- Polyp detection rate [ Time Frame: 1 hour ]Detection of any colonic polyp, irrespective of histologic type, during each procedure.
- Dose of medication [ Time Frame: 1 hour ]Dose of sedative and analgesic medication needed to complete the colonoscopy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633333
|Kristiansand, Norway, N-4604|
|The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology|
|Principal Investigator:||Kjetil K Garborg, MD||Sorlandet Hospital HF Kristiansand, Norway|