RCT of Air Insufflation Versus Water Infusion Colonoscopy by Supervised Trainees

This study has been completed.

Sponsor:

Information provided by:

East Bay Institute for Research and Education

ClinicalTrials.gov Identifier:

NCT00841282

First received: February 9, 2009

Last updated: February 10, 2009

Last verified: February 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	February 9, 2009
Last Updated Date	February 10, 2009
Start Date ^ICMJE	October 2008
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 10, 2009)	Increments of medications used for sedation [ Time Frame: duration of procedure ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00841282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 10, 2009)	pain score during colonoscopy [ Time Frame: duration of procedure ] [ Designated as safety issue: Yes ] success of cecal intubation [ Time Frame: duration of study ] [ Designated as safety issue: No ] willingness to repeat colonoscopy [ Time Frame: duration of study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	RCT of Air Insufflation Versus Water Infusion Colonoscopy by Supervised Trainees
Official Title ^ICMJE	Comparison of Study Versus Conventional Method for Performing Colonoscopy by Supervised Trainees for Colorectal Cancer Screening and Surveillance
Brief Summary	Our aim is to perform a randomized-controlled trial comparing air insufflation sedated colonoscopy (conventional method) vs. water infusion sedated colonoscopy (study method) by supervised trainees. Randomized trials demonstrating reduced need for sedation medications without compromising patients' comfort, cecal intubation rates or polyps detection may cause a paradigm shift and positively alter the way traditional colonoscopy is performed and future endoscopists are trained.
Detailed Description	Background: A novel water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without medications and significantly increased successful cecal intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy. Aim: To perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients by supervised trainees. Hypothesis: Compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy. Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The conventional and the study method for colonoscopy were implemented as previously described. Additional pain medications were administered at the patients' request. Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy. Limitations: Single VA site, older male population
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Colorectal Cancer
Intervention ^ICMJE	Procedure: Colonoscopy for colorectal cancer screening Procedure: Water Infusion Colonoscopy water infusion in lieu of air insufflation for screening colonoscopy Procedure: Air insufflation colonoscopy Conventional colonoscopy with air insufflation
Study Arm (s)	Active Comparator: 1 Water Infusion in lieu of Air Insufflation Colonoscopy Interventions: Procedure: Colonoscopy for colorectal cancer screening Procedure: Water Infusion Colonoscopy Placebo Comparator: 2 Air Insufflation Colonoscopy Interventions: Procedure: Colonoscopy for colorectal cancer screening Procedure: Air insufflation colonoscopy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	62
Completion Date	February 2009
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion criteria: Adult (> 50 years old) male and female patients who are scheduled and consented for screening or surveillance colonoscopy, Accept randomization to the study or the conventional method, and agree to complete study questionnaires The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2 Exclusion criteria: Patients who have contraindications for sedation, decline to participate, unable to give informed consent or complete the questionnaires due to language or other difficulties will be excluded Excluded patients will be managed by usual procedures
Gender	Both
Ages	50 Years to 80 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00841282
Other Study ID Numbers ^ICMJE	EBIRE-GI-002
Has Data Monitoring Committee	Yes
Responsible Party	Joseph Leung, MD, Section of Gastroenterology, Sacramento VA Medical Center
Study Sponsor ^ICMJE	East Bay Institute for Research and Education
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	East Bay Institute for Research and Education
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top