Cap-assisted Water Immersion Versus Water Immersion Colonoscopy

Not Applicable

Completed

• Conditions: Colonoscopy
• Interventions: Procedure: water immersion colonoscopy; Device: soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope

• Registration Number: NCT01547247
• Lead Sponsor: Vitkovice Hospital

Brief Summary

Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. The investigators would like to assess whether combination of cap-fitted colonoscopy and water immersion insertion is feasible and safe method of diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that the use of cap is able to shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy are assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-26
• Study First Submitted QC: 2012-03-03
• Study First Posted: 2012-03-07
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Results First Submitted: 2012-12-20
• Results First Submitted QC: 2012-12-20
• Results First Posted: 2013-01-28
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-04
• Last Update Posted: 2015-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• outpatient diagnostic colonoscopy
• bowel prep with macrogolum
• initial 2 mg of midazolam i.v.
• signed informed consent form

Exclusion Criteria

• planned therapeutic intervention
• colorectal surgery in history
• known inflammatory bowel disease or colorectal cancer
• refusal of sedation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
water immersion colonoscopy	water immersion colonoscopy	Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
cap-assisted water immersion colonoscopy	soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope	Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.

Primary Outcome Measures

Name	Time	Method
Cecal Intubation Time	3 months	The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.

Secondary Outcome Measures

Name	Time	Method
Patient Comfort During Insertion Phase of the Colonoscopy	3 months
Success Rate of Minimal Sedation Colonoscopy	3 months	A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam.

Trial Locations

Locations (1)

Digestive Diseases Center, Vitkovice Hospital; 🇨🇿 Ostrava, Czech Republic