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Warm Water for Unsedated Colonoscopy (WW)

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: NCT00905554
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : October 25, 2011
Last Update Posted : October 25, 2011
Sponsor:
Information provided by (Responsible Party):
Vittorio Terruzzi, Valduce Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Colonoscopy Procedure: warm water irrigation Procedure: air insufflation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
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
Study Start Date : April 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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
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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
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Italy
Valduce Hospital
Como, CO, Italy, 22100
Sponsors and Collaborators
Valduce Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vittorio Terruzzi, MD, Valduce Hospital
ClinicalTrials.gov Identifier: NCT00905554    
Other Study ID Numbers: WW01
First Posted: May 20, 2009    Key Record Dates
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