RCT of Air Insufflation Versus Water Infusion Colonoscopy

Not Applicable

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00785889
• Lead Sponsor: East Bay Institute for Research and Education

Brief 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

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-09
• Study Completion: 2008-10
• Status Verified: 2008-11
• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Last Update Submitted: 2008-11-13
• Last Update Posted: 2008-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• healthy individual 50 years or older
• eligible for colorectal cancer screening or surveillance

Exclusion Criteria

• patients who do not understand or failed to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Increments of medications used for sedation	duration of procedure

Secondary Outcome Measures

Name	Time	Method
pain scores during colonoscopy	duration of procedure
success with cecal intubation	during procedure
willingness to repeat colonoscopy	after procedure

Trial Locations

Locations (1)

Sacramento VA Medical Center, VANCHCS; 🇺🇸 Mather, California, United States