Clinical Trials Directory

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

TypeNameDescription
PROCEDUREwater infusion colonoscopywater 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.