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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Premysl Falt MD, Vitkovice Hospital
ClinicalTrials.gov Identifier:
NCT01440543
First received: September 19, 2011
Last updated: December 20, 2012
Last verified: December 2012
Results First Received: December 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   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  
Number of Participants  
[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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

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


  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
Study First Received: September 19, 2011
Results First Received: December 19, 2012
Last Updated: December 20, 2012
Health Authority: Czech Republic: State Institute for Drug Control