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Cap-assisted Water Immersion Versus Water Immersion Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Premysl Falt MD, Vitkovice Hospital
ClinicalTrials.gov Identifier:
NCT01547247
First received: February 26, 2012
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Cap-assisted Water Immersion Versus Water Immersion Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vitkovice Hospital:

Primary Outcome Measures:
  • Cecal Intubation Time [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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:
  • Patient Comfort During Insertion Phase of the Colonoscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Success Rate of Minimal Sedation Colonoscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 208
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Premysl Falt MD, Principal Investigator, Vitkovice Hospital
ClinicalTrials.gov Identifier: NCT01547247     History of Changes
Other Study ID Numbers: DDC VN 03
Study First Received: February 26, 2012
Results First Received: December 20, 2012
Last Updated: December 20, 2012
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Vitkovice Hospital:
colonoscopy
cap-assisted colonoscopy
water immersion colonoscopy

ClinicalTrials.gov processed this record on May 16, 2013