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Warm Water and Unsedated Colonoscopy (WW)

P

Presidio Ospedaliero Santa Barbara

Status and phase

Completed
Early Phase 1

Conditions

Gastrointestinal Diseases
Digestive System Diseases

Treatments

Other: air insufflation
Other: warm water irrigation

Study type

Interventional

Funder types

Other

Identifiers

NCT01463319
ASL07_WW-2011

Details and patient eligibility

About

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.

Enrollment

818 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

818 participants in 2 patient groups

warm water irrigation
Experimental group
Description:
warm water irrigation during insertion phase of colonoscopy
Treatment:
Other: warm water irrigation
air insufflation
Experimental group
Description:
air insufflation during insertion phase of colonoscopy
Treatment:
Other: air insufflation

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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