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Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy (Water/CO2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01440543
First Posted: September 26, 2011
Last Update Posted: January 28, 2013
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):
Premysl Falt MD, Vitkovice Hospital
Results First Submitted: December 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Diagnostic
Condition: Colonoscopy
Interventions: Procedure: Water immersion insertion AND CO2 insufflation
Procedure: Water immersion insertion
Procedure: CO2 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
  • recruitment process between January and June 2011
  • outpatients referred to our endoscopy unit for diagnostic colonoscopy

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
  • a total of 548 patients were assessed for eligibility
  • a total of 420 patients were randomized after exclusion of 128 subjects because of not fulfilled inclusion criteria
  • a total of 404 patients were analyzed after exclusion of 16 subjects (poor bowel preparation, IBD, argon plasmacoagulation, endoscopic resection or malignant obstruction)

Reporting Groups
  Description
Water/Air Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
CO2/CO2 CO2 insufflation during both colonoscope insertion and withdrawal
Water/CO2 water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
Air/Air room air insufflation during both colonoscope insertion and withdrawal

Participant Flow:   Overall Study
    Water/Air   CO2/CO2   Water/CO2   Air/Air
STARTED   106   105   102   107 
COMPLETED   102   101   100   101 
NOT COMPLETED   4   4   2   6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Water/Air Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
CO2/CO2 CO2 insufflation during both colonoscope insertion and withdrawal
Water/CO2 water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
Air/Air room air insufflation during both colonoscope insertion and withdrawal
Total Total of all reporting groups

Baseline Measures
   Water/Air   CO2/CO2   Water/CO2   Air/Air   Total 
Overall Participants Analyzed 
[Units: Participants]
 106   105   102   107   420 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   55   60   54   58   227 
>=65 years   51   45   48   49   193 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.1  (13.9)   59.4  (14.5)   58.2  (13.4)   58.7  (13.8)   59.2  (14.1) 
Gender 
[Units: Participants]
         
Female   50   52   49   51   202 
Male   56   53   53   56   218 
Region of Enrollment 
[Units: Participants]
         
Czech Republic   106   105   102   107   420 


  Outcome Measures

1.  Primary:   Success Rate of Minimal Sedation Colonoscopy   [ Time Frame: 6 months ]

2.  Primary:   Success Rate of Minimal Sedation Colonoscopy   [ Time Frame: six months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Patient Comfort During the Procedure and During First 24 Hours After Procedure   [ Time Frame: six months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
There were no procedure- or sedation-related complications recorded in the study.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Premysl Falt MD
Organization: Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic
phone: +420602689561
e-mail: faltprem@centrum.cz


Publications of Results:

Responsible Party: Premysl Falt MD, Vitkovice Hospital
ClinicalTrials.gov Identifier: NCT01440543     History of Changes
Other Study ID Numbers: DDC VN 01
First Submitted: September 19, 2011
First Posted: September 26, 2011
Results First Submitted: December 19, 2012
Results First Posted: January 28, 2013
Last Update Posted: January 28, 2013