ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy
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|ClinicalTrials.gov Identifier: NCT01438645|
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : January 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Colonic Neoplasms Iron Deficiency Anemia Diarrhea||Device: Olympus ScopeGuide||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy for Improved Endoscopic Performance and Enhanced Patient Experience|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||December 2012|
Experimental: ScopeGuide-assisted colonoscopy
These patients will undergo colonoscopy with the assistance of the Olympus ScopeGuide system.
Device: Olympus ScopeGuide
ScopeGuide-assisted colonoscopy using Olympus CF-H180DL variable-stiffness colonoscopes equipped with ScopeGuide capabilities. ScopeGuide will provide the endoscopist with a 3-dimensional image on the monitor depicting the shape of the colonoscope inside the patient's body as it moves through the colon.
Other Name: Magnetic endoscopy imaging
No Intervention: Conventional colonoscopy
These patients will undergo colonoscopy identical to that in the intervention arm, except with endoscopes lacking the ScopeGuide system.
- Sedation Score [ Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure) ]The main efficacy parameter is the amount of sedation used during colonoscopy, expressed as the mean for each group. Since our conscious sedation consists of two different drugs, the doses of each will be converted into a numerical score, such that typical 1 mg dose increments of midazolam and 25 mcg increments of fentanyl will each be assigned a score of '1,' and the two will be added together to give the sedation score.
- Patient comfort [ Time Frame: 1 day (immediate outcome assessment after recovery from endoscopy procedure) ]Patients wil complete a 10 cm visual analogue pain scale (VAS) that will be converted to a numerical score (0-100) with each number representing 1 mm on the 10 cm VAS from 0 at its left extreme (representing 'no pain') to 100 on its right extreme (representing 'unbearably severe pain'). The mean pain score will then be determined for each of the groups.
- Time-to-cecum [ Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure) ]Time from initial insertion of colonoscope until successful intubation of the cecum (min)
- Cecal intubation rate [ Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure) ]Proportion of colonoscopy procedures resulting in successful intubation of the cecum.
- Ancillary maneuvers to facilitate procedure [ Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure) ]Number of added maneuvers, including abdominal pressure, repositioning of patient, endoscope loop reduction techniques, used to facilitate advancement of endoscope during procedure.
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): NCT01438645
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G 2X8|
|Principal Investigator:||Christopher W Teshima, MD FRCPC||University of Alberta|