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

September 19, 2011
December 20, 2012
January 2011
July 2011   (final data collection date for primary outcome measure)
  • Success Rate of Minimal Sedation Colonoscopy [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    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.
  • Success Rate of Minimal Sedation Colonoscopy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01440543 on ClinicalTrials.gov Archive Site
Patient Comfort During the Procedure and During First 24 Hours After Procedure [ Time Frame: six months ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy
Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Colonoscopy
  • 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
  • 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
  • Procedure: CO2 insufflation
    - CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal
  • Experimental: Water/CO2
    water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
    Intervention: Procedure: Water immersion insertion AND CO2 insufflation
  • Experimental: Water/Air
    Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
    Intervention: Procedure: Water immersion insertion
  • Experimental: CO2/CO2
    CO2 insufflation during both colonoscope insertion and withdrawal
    Intervention: Procedure: CO2 insufflation
  • No Intervention: Air/Air
    room air insufflation during both colonoscope insertion and withdrawal
Falt P, Liberda M, Smajstrla V, Kliment M, Bártková A, Tvrdík J, Fojtík P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
420
September 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01440543
DDC VN 01
No
Premysl Falt MD, Vitkovice Hospital
Vitkovice Hospital
Not Provided
Principal Investigator: Premysl Falt, MD Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic
Vitkovice Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP