Warm Water for Unsedated Colonoscopy (WW)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Vittorio Terruzzi, Valduce Hospital

ClinicalTrials.gov Identifier:

NCT00905554

First received: May 15, 2009

Last updated: September 15, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 15, 2009
Last Updated Date	September 15, 2011
Start Date ^ICMJE	April 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 18, 2009)	Number of Patients Undergoing Complete Unsedated Colonoscopy [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00905554 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 15, 2011)	Evaluation of Pain and Tolerability Scores [ Time Frame: 6-9 months ] [ Designated as safety issue: No ] 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)
Original Secondary Outcome Measures ^ICMJE (submitted: May 18, 2009)	evaluation of pain and tolerability scores [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Warm Water for Unsedated Colonoscopy
Official Title ^ICMJE	Warm Water Irrigation Versus Standard Air Insufflation for Unsedated Colonoscopy: a Randomized Controlled Trial
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care
Condition ^ICMJE	Colonoscopy
Intervention ^ICMJE	Procedure: warm water irrigation warm water irrigation during insertion phase of colonoscopy Procedure: air insufflation air insufflation during the insertion phase of colonoscopy
Study Arm (s)	Experimental: warm water warm water irrigation during the insertion phase of colonoscopy Intervention: Procedure: warm water irrigation Active Comparator: air air insufflation during the insertion phase of colonoscopy Intervention: Procedure: air insufflation
Publications *	Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	230
Completion Date	February 2010
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT00905554
Other Study ID Numbers ^ICMJE	WW01
Has Data Monitoring Committee	No
Responsible Party	Vittorio Terruzzi, Valduce Hospital
Study Sponsor ^ICMJE	Valduce Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Valduce Hospital
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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