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Warm Water and Unsedated Colonoscopy (WW)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sergio Cadoni, M.D., Presidio Ospedaliero Santa Barbara
ClinicalTrials.gov Identifier:
NCT01463319
First received: October 25, 2011
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no incidence of drug-related side effects. May be slightly painful or discomforting for the patient. Based on numerous recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of warm water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation or with a low dose of sedatives.


Condition Intervention Phase
Gastrointestinal Diseases
Digestive System Diseases
 Other: air insufflation
Other: warm water irrigation
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Warm Water Colonoscopy: a Novel Method for Unsedated Colonoscopy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Presidio Ospedaliero Santa Barbara:

Primary Outcome Measures:
  • number of patients undergoing complete unsedated or slightly sedated colonoscopy [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    number of patients undergoing complete unsedated conoloscopy with a pain score (as per used scale) ≤2, or patients with no more than that score AND ≤2 mg Midazolam E.V.


Secondary Outcome Measures:
  • evaluation of pain and tolerability scores [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Numeric rating scale, Verbal Descriptor Scale and Faces Pain Scale (0= no pain, 10 worst possible pain.) Hicks CL et al. Pain 2001;93:173-183. Bieri D. et al. Pain. 1990;41(2):138-50.

  • percentage of caecum intubation [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • time to reach caecum [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Adenoma detection rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Proportion of patients with at least one adenoma of any size


Enrollment: 818
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: warm water irrigation
warm water irrigation during insertion phase of colonoscopy
 Other: warm water irrigation
warm water irrigation during insertion phase colonoscopy
Experimental: air insufflation
air insufflation during insertion phase of colonoscopy
 Other: air insufflation
air insufflation during insertion phase colonoscopy

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 Years to 85 Years
  • adult patients willing to undergo colonoscopy without routine initial sedation

Exclusion Criteria:

  • refuse to initiate colonoscopy without routine sedation
  • inadequate bowel preparation
  • incapacity to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463319

Locations
Italy
Servizio Endoscopia Digestiva
Iglesias, Carbonia-Iglesias, Italy, 09016
U.O.S.D. Diagnostica e Terapia Endoscopica
San Gavino Monreale, Medio Campidano (VS), Italy, 09037
Sponsors and Collaborators
Presidio Ospedaliero Santa Barbara
Investigators
Principal Investigator: Sergio Cadoni, M.D. A.S.L. 07 Sardegna
  More Information

No publications provided

Responsible Party: Sergio Cadoni, M.D., Responsabile Servizio Endoscopia Digestiva, Presidio Ospedaliero Santa Barbara
ClinicalTrials.gov Identifier: NCT01463319     History of Changes
Other Study ID Numbers: ASL07_WW-2011
Study First Received: October 25, 2011
Last Updated: February 7, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Presidio Ospedaliero Santa Barbara:
colonoscopy
warm water method
hydrocolonoscopy
unsedated colonoscopy

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 23, 2013