RCT of Air Insufflation Versus Water Infusion Colonoscopy by Supervised Trainees

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: Colonoscopy for colorectal cancer screening; Procedure: Water Infusion Colonoscopy; Procedure: Air insufflation colonoscopy

• Registration Number: NCT00841282
• Lead Sponsor: East Bay Institute for Research and Education

Brief Summary

Our aim is to perform a randomized-controlled trial comparing air insufflation sedated colonoscopy (conventional method) vs. water infusion sedated colonoscopy (study method) by supervised trainees. Randomized trials demonstrating reduced need for sedation medications without compromising patients' comfort, cecal intubation rates or polyps detection may cause a paradigm shift and positively alter the way traditional colonoscopy is performed and future endoscopists are trained.

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 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

Study Timeline

• Study Start: 2008-10
• Status Verified: 2009-02
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2009-02-09
• Study First Submitted QC: 2009-02-10
• Last Update Submitted: 2009-02-10
• Study First Posted: 2009-02-11
• Last Update Posted: 2009-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Colonoscopy for colorectal cancer screening	Water Infusion in lieu of Air Insufflation Colonoscopy
2	Colonoscopy for colorectal cancer screening	Air Insufflation Colonoscopy
1	Water Infusion Colonoscopy	Water Infusion in lieu of Air Insufflation Colonoscopy
2	Air insufflation colonoscopy	Air Insufflation Colonoscopy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
success of cecal intubation	duration of study
pain score during colonoscopy	duration of procedure
willingness to repeat colonoscopy	duration of study

Trial Locations

Locations (1)

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