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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 Description
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Brief Summary:

Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure.

This prospective, randomized, single-center trial was designed to evaluate whether the combination of water immersion during insertion and CO2 insufflation during withdrawal (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other colonoscopy methods (Water/Air, CO2/CO2, Air/Air).


Condition or disease Intervention/treatment Phase
Colonoscopy Procedure: Water immersion insertion AND CO2 insufflation Procedure: Water immersion insertion Procedure: CO2 insufflation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial
Study Start Date : January 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Water/CO2
water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
 Procedure: Water immersion insertion AND CO2 insufflation
  • room temperature water infused by water pump into the colon just to facilitate scope insertion
  • CO2 insufflation by CO2 insufflation system during colonoscope withdrawal and mucosal inspection
Experimental: Water/Air
Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
 Procedure: Water immersion insertion
  • room temperature water infused by water pump into the colon just to facilitate scope insertion
  • standard room air insufflation during colonoscope withdrawal and mucosal inspection
Experimental: CO2/CO2
CO2 insufflation during both colonoscope insertion and withdrawal
 Procedure: CO2 insufflation
- CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal
No Intervention: Air/Air
room air insufflation during both colonoscope insertion and withdrawal


Outcome Measures
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Primary Outcome Measures :
  1. Success Rate of Minimal Sedation Colonoscopy [ Time Frame: six months ]
    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.

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


Secondary Outcome Measures :
  1. Patient Comfort During the Procedure and During First 24 Hours After Procedure [ Time Frame: six months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men and women older than 18 years referred for diagnostic outpatient colonoscopy
  • provided written consent

Exclusion Criteria:

  • history of colorectal surgery
  • known diagnosis of inflammatory bowel disease
  • chronic benzodiazepine use
  • refusal of minimal sedation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440543


Locations
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Czech Republic
Digestive Diseases Center - Vitkovice Hospital
Ostrava, Czech Republic, 703 84
Sponsors and Collaborators
Vitkovice Hospital
Investigators
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Principal Investigator: Premysl Falt, MD Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic
More Information
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Publications of Results:

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Responsible Party: Premysl Falt MD, Principal Investigator, Vitkovice Hospital
ClinicalTrials.gov Identifier: NCT01440543    
Other Study ID Numbers: DDC VN 01
First Posted: September 26, 2011    Key Record Dates
Results First Posted: January 28, 2013
Last Update Posted: January 28, 2013
Last Verified: December 2012
Keywords provided by Premysl Falt MD, Vitkovice Hospital:
colonoscopy
water immersion
CO2 insufflation
 patients referred for diagnostic outpatient colonoscopy
(screening, surveillance, symptoms)
patient discomfort associated with diagnostic colonoscopy