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Warm Water Versus Room Temperature Water Immersion Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Premysl Falt MD, Vitkovice Hospital
ClinicalTrials.gov Identifier:
NCT01582178
First received: April 18, 2012
Last updated: September 19, 2013
Last verified: September 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Vitkovice Hospital:

Primary Outcome Measures:
  • Cecal Intubation Time [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Cecal Intubation Time [ Time Frame: 1-30 ] [ Designated as safety issue: No ]
    = 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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 18, 2012
Results First Received: June 2, 2013
Last Updated: September 19, 2013
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Vitkovice Hospital:
colonoscopy
warm water immersion
cool water immersion

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

ClinicalTrials.gov processed this record on November 20, 2014