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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
  Purpose

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 Intervention
Colonoscopy
Procedure: Water immersion insertion AND CO2 insufflation
Procedure: Water immersion insertion
Procedure: CO2 insufflation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial

Resource links provided by NLM:


Further study details as provided by Vitkovice Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 420
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440543

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

Publications:
Responsible Party: Premysl Falt MD, Principal Investigator, 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

Keywords provided by Vitkovice Hospital:
colonoscopy
water immersion
CO2 insufflation
patients referred for diagnostic outpatient colonoscopy
(screening, surveillance, symptoms)
patient discomfort associated with diagnostic colonoscopy

ClinicalTrials.gov processed this record on November 19, 2014