Comparison of Study Versus Conventional Method for Performing Colonoscopy by Supervised Trainees for Colorectal Cancer Screening and Surveillance
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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Increments of medications used for sedation
duration of procedure
United States: Institutional Review Board
|Sacramento VA Medical Center,||Mather, California 95655|