Clinical Trials Directory

Trials / Completed

CompletedNCT01547247

Cap-assisted Water Immersion Versus Water Immersion Colonoscopy

Cap-assisted Water Immersion Versus Water Immersion Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
208 (actual)
Sponsor
Vitkovice Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEsoft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscopeColonoscopy with transparent cap attached to the tip of the colonoscope and water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.
PROCEDUREwater immersion colonoscopyColonoscopy without transparent cap using water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.

Timeline

Start date
2012-01-01
Primary completion
2012-05-01
Completion
2012-06-01
First posted
2012-03-07
Last updated
2015-10-23
Results posted
2013-01-28

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT01547247. Inclusion in this directory is not an endorsement.