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Cap-assisted Water Immersion Versus Water Immersion Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01547247
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : January 28, 2013
Last Update Posted : October 23, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Colonoscopy Device: soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope Procedure: water immersion colonoscopy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Cap-assisted Water Immersion Versus Water Immersion Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial
Study Start Date : January 2012
Primary Completion Date : May 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: cap-assisted water immersion colonoscopy
Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Device: soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope
Colonoscopy with transparent cap attached to the tip of the colonoscope and water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.
Active Comparator: water immersion colonoscopy
Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Procedure: water immersion colonoscopy
Colonoscopy without transparent cap using water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.


Outcome Measures

Primary Outcome Measures :
  1. Cecal Intubation Time [ Time Frame: 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 :
  1. Patient Comfort During Insertion Phase of the Colonoscopy [ Time Frame: 3 months ]
  2. Success Rate of Minimal Sedation Colonoscopy [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547247


Locations
Czech Republic
Digestive Diseases Center, Vitkovice Hospital
Ostrava, Czech Republic, 703 84
Sponsors and Collaborators
Vitkovice Hospital
Investigators
Principal Investigator: Premysl Falt, MD Digestive Diseases Center, Vitkovice Hospital
More Information

Publications:
Responsible Party: Premysl Falt MD, Principal Investigator, Vitkovice Hospital
ClinicalTrials.gov Identifier: NCT01547247     History of Changes
Other Study ID Numbers: DDC VN 03
First Posted: March 7, 2012    Key Record Dates
Results First Posted: January 28, 2013
Last Update Posted: October 23, 2015
Last Verified: October 2015

Keywords provided by Premysl Falt MD, Vitkovice Hospital:
colonoscopy
cap-assisted colonoscopy
water immersion colonoscopy