Trials / Completed
CompletedNCT00785889
RCT of Air Insufflation Versus Water Infusion Colonoscopy
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- East Bay Institute for Research and Education · Academic / Other
- Sex
- All
- Age
- 45 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
Compared with the conventional (air) method, patients examined by the study (water) method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.
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. 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | water infusion colonoscopy | water infusion in lieu of air insufflation for screening colonoscopy |
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2008-09-01
- Completion
- 2008-10-01
- First posted
- 2008-11-05
- Last updated
- 2008-11-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00785889. Inclusion in this directory is not an endorsement.