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

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ClinicalTrials.gov Identifier: NCT01440543
Recruitment Status : Completed
First Posted : September 26, 2011
Results First Posted : January 28, 2013
Last Update Posted : January 28, 2013
Sponsor:
Information provided by (Responsible Party):
Premysl Falt MD, Vitkovice Hospital

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
Enrollment 420
Recruitment Details
  • recruitment process between January and June 2011
  • outpatients referred to our endoscopy unit for diagnostic colonoscopy
Pre-assignment Details
  • 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)
Arm/Group Title Water/Air CO2/CO2 Water/CO2 Air/Air
Hide Arm/Group Description Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal CO2 insufflation during both colonoscope insertion and withdrawal water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal room air insufflation during both colonoscope insertion and withdrawal
Period Title: Overall Study
Started 106 105 102 107
Completed 102 101 100 101
Not Completed 4 4 2 6
Arm/Group Title Water/Air CO2/CO2 Water/CO2 Air/Air Total
Hide Arm/Group Description Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal CO2 insufflation during both colonoscope insertion and withdrawal water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal room air insufflation during both colonoscope insertion and withdrawal Total of all reporting groups
Overall Number of Baseline Participants 106 105 102 107 420
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 105 participants 102 participants 107 participants 420 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
55
  51.9%
60
  57.1%
54
  52.9%
58
  54.2%
227
  54.0%
>=65 years
51
  48.1%
45
  42.9%
48
  47.1%
49
  45.8%
193
  46.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 105 participants 102 participants 107 participants 420 participants
60.1  (13.9) 59.4  (14.5) 58.2  (13.4) 58.7  (13.8) 59.2  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 105 participants 102 participants 107 participants 420 participants
Female
50
  47.2%
52
  49.5%
49
  48.0%
51
  47.7%
202
  48.1%
Male
56
  52.8%
53
  50.5%
53
  52.0%
56
  52.3%
218
  51.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Czech Republic Number Analyzed 106 participants 105 participants 102 participants 107 participants 420 participants
106 105 102 107 420
1.Primary Outcome
Title Success Rate of Minimal Sedation Colonoscopy
Hide Description Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam.
Time Frame six months
Outcome Measure Data Not Reported
2.Primary Outcome
Title Success Rate of Minimal Sedation Colonoscopy
Hide Description A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level > 3 using a 7-point Likert scale [7] (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical power was calculated for the primary endpoint. A sample size of 145 subjects per insertion arm was calculated using two-tailed α = 0,05, β = 0,05, assuming that 80% versus 60% success rate in the water (Water/CO2 and Water/Air) and gas (CO2/CO2 and Air/Air) insertion arms would have been clinically relevant.
Arm/Group Title CO2/CO2 Water/Air Water/CO2 Air/Air
Hide Arm/Group Description:
CO2 insufflation during both colonoscope insertion and withdrawal
Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
room air insufflation during both colonoscope insertion and withdrawal
Overall Number of Participants Analyzed 102 100 101 101
Measure Type: Number
Unit of Measure: percentage of all participants
82.4 97 97 84.2
3.Secondary Outcome
Title Patient Comfort During the Procedure and During First 24 Hours After Procedure
Hide Description Comfort was assessed using a 18-point questionnaire form based on 0-6 continuous scale (0 = best, 6 = worst)- abdominal pain during, 30 minutes, 3, 12 and 24 hours after the procedure, bloating duringm 30 minutes, 3, 12 and 24 hours after the procedure, flatus during, 30 minutes, 3, 12 and 24 hours after the procedure, impact on patient´s daily activities during first 24 hours after the procedure, willingnes to repeat the colonoscopy and overall satisfaction with the procedure
Time Frame six months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Water/Air CO2/CO2 Water/CO2 Air/Air
Hide Arm/Group Description Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal CO2 insufflation during both colonoscope insertion and withdrawal water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal room air insufflation during both colonoscope insertion and withdrawal
All-Cause Mortality
Water/Air CO2/CO2 Water/CO2 Air/Air
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Water/Air CO2/CO2 Water/CO2 Air/Air
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Water/Air CO2/CO2 Water/CO2 Air/Air
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
There were no procedure- or sedation-related complications recorded in the study.
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
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