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Warm Water for Unsedated Colonoscopy (WW)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00905554
First Posted: May 20, 2009
Last Update Posted: October 25, 2011
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):
Vittorio Terruzzi, Valduce Hospital
  Purpose
Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of drug-related side effects, although it may be painful for the patient. Based on recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation.

Condition Intervention
Colonoscopy Procedure: warm water irrigation Procedure: air insufflation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Warm Water Irrigation Versus Standard Air Insufflation for Unsedated Colonoscopy: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Vittorio Terruzzi, Valduce Hospital:

Primary Outcome Measures:
  • Number of Patients Undergoing Complete Unsedated Colonoscopy [ Time Frame: 6-9 months ]

Secondary Outcome Measures:
  • Evaluation of Pain and Tolerability Scores [ Time Frame: 6-9 months ]
    Entity of pain and tolerability level on a visual analogic scale (ranging from 0 - no pain, optimal tolerability - to 100 mm - worst pain ever, unbearable)


Enrollment: 230
Study Start Date: April 2009
Study Completion Date: February 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: warm water
warm water irrigation during the insertion phase of colonoscopy
Procedure: warm water irrigation
warm water irrigation during insertion phase of colonoscopy
Active Comparator: air
air insufflation during the insertion phase of colonoscopy
Procedure: air insufflation
air insufflation during the insertion phase of colonoscopy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult outpatients willing to undergo colonoscopy without routine initial sedation

Exclusion Criteria:

  • refuse to initiate colonoscopy without routine sedation
  • inadequate bowel preparation
  • incapacity to give informed consent
  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): NCT00905554


Locations
Italy
Valduce Hospital
Como, CO, Italy, 22100
Sponsors and Collaborators
Valduce Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vittorio Terruzzi, MD, Valduce Hospital
ClinicalTrials.gov Identifier: NCT00905554     History of Changes
Other Study ID Numbers: WW01
First Submitted: May 15, 2009
First Posted: May 20, 2009
Results First Submitted: August 5, 2011
Results First Posted: October 25, 2011
Last Update Posted: October 25, 2011
Last Verified: September 2011

Keywords provided by Vittorio Terruzzi, Valduce Hospital:
sedation
warm water