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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
Results First Received: August 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Supportive Care
Condition: Colonoscopy
Interventions: Procedure: warm water irrigation
Procedure: air insufflation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
medical clinic since march 2009 until sample size was reached

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
no patient excluded from the study flow after being allocated in the study or control arm

Reporting Groups
  Description
Warm Water warm water irrigation during the insertion phase of colonoscopy
Air Insufflation air insufflation during the insertion phase of colonoscopy

Participant Flow:   Overall Study
    Warm Water     Air Insufflation  
STARTED     116     114  
COMPLETED     116     114  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Warm Water warm water irrigation during the insertion phase of colonoscopy
Air Insufflation air insufflation during the insertion phase of colonoscopy
Total Total of all reporting groups

Baseline Measures
    Warm Water     Air Insufflation     Total  
Number of Participants  
[units: participants]
 		  116     114     230  
Age  
[units: participants]
 		     
<=18 years     2     1     3  
Between 18 and 65 years     108     109     217  
>=65 years     6     4     10  
Age  
[units: years]
Mean ± Standard Deviation 		  58.4  ± 11.5     58.8  ± 13.3     58.4  ± 12.1  
Gender  
[units: participants]
 		     
Female     48     48     96  
Male     68     66     134  
Region of Enrollment  
[units: participants]
 		     
Italy     116     114     230  



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

2.  Secondary:   Evaluation of Pain and Tolerability Scores   [ Time Frame: 6-9 months ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Vittorio Terruzzi, MD
Organization: Valduce Hospital - Como - Italy
phone: +39031324009
e-mail: vterruzzi@valduce.it


No publications provided by Valduce Hospital

Publications automatically indexed to this study:


Responsible Party: Vittorio Terruzzi, Valduce Hospital
ClinicalTrials.gov Identifier: NCT00905554     History of Changes
Other Study ID Numbers: WW01
Study First Received: May 15, 2009
Results First Received: August 5, 2011
Last Updated: September 15, 2011
Health Authority: Italy: Ethics Committee