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Warm Water Versus Room Temperature Water Immersion Colonoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01582178
First Posted: April 20, 2012
Last Update Posted: September 20, 2013
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.
Information provided by (Responsible Party):
Premysl Falt MD, Vitkovice Hospital
  Purpose

Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. There was used warm water infusion for colonoscope insertion in most of the water immersion colonoscopy trials.

The investigators have been using room temperature water (20-24°C) for water immersion and the investigators did not notice any drawback of it. In our opinion, it is simpler and cheaper option for water immersion colonoscopy and proof of its efficacy and safety could support the use of water immersion technique in routine practice.

The primary endpoint is cecal intubation time and the investigators suppose that the use of warm water infusion does not 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 will be also assessed.


Condition Intervention
Colorectal Cancer Procedure: Warm Water Immersion Colonoscopy Procedure: Cool Water Immersion Colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Warm Water Versus Room Temperature Water Immersion Colonoscopy - a Prospective, Randomized, Double-blind, Single-center Trial

Resource links provided by NLM:


Further study details as provided by Premysl Falt MD, Vitkovice Hospital:

Primary Outcome Measures:
  • Cecal Intubation Time [ Time Frame: 3 months ]
  • Cecal Intubation Time [ Time Frame: 1-30 ]
    = 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 ]

Enrollment: 212
Study Start Date: June 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Warm Water Immersion Colonoscopy
Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Procedure: Warm Water Immersion Colonoscopy
Colonoscopy using warm water (37°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.
Active Comparator: Cool Water Immersion Colonoscopy
Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Procedure: Cool Water Immersion Colonoscopy
Colonoscopy using room temperature water (20-24°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.

  Eligibility

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): NCT01582178


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: NCT01582178     History of Changes
Other Study ID Numbers: DDC VN 04
First Submitted: April 18, 2012
First Posted: April 20, 2012
Results First Submitted: June 2, 2013
Results First Posted: August 1, 2013
Last Update Posted: September 20, 2013
Last Verified: September 2013

Keywords provided by Premysl Falt MD, Vitkovice Hospital:
colonoscopy
warm water immersion
cool water immersion

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases