RCT of Air Insufflation Versus Water Infusion Colonoscopy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
|Official Title:||A Randomized Controlled Comparison of Warm Water Infusion in Lieu of Air Insufflation vs. Air Insufflation for Aiding Colonoscopy Insertion in Sedated Patients Undergoing Colorectal Cancer (CRC) Screening and Surveillance.|
- Increments of medications used for sedation [ Time Frame: duration of procedure ] [ Designated as safety issue: Yes ]
- pain scores during colonoscopy [ Time Frame: duration of procedure ] [ Designated as safety issue: Yes ]
- success with cecal intubation [ Time Frame: during procedure ] [ Designated as safety issue: No ]
- willingness to repeat colonoscopy [ Time Frame: after procedure ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||October 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Procedure: water infusion colonoscopy
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785889
|United States, California|
|Sacramento VA Medical Center, VANCHCS|
|Mather, California, United States, 95655|
|Principal Investigator:||Joseph Leung, MD||Sacramento VA Medical Center, GI Section|