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Completed

NCT Number: NCT01463319

Warm Water and Unsedated Colonoscopy

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.

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Key information

Conditions

Gastrointestinal Diseases Digestive System Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Servizio Endoscopia Digestiva, Iglesias, Carbonia-Iglesias, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

air insufflation

Other

air insufflation during insertion phase colonoscopy

warm water irrigation

Other

warm water irrigation during insertion phase colonoscopy

Primary outcomes

  1. number of patients undergoing complete unsedated or slightly sedated colonoscopy

    Time frame: 9 months

    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 outcomes

  1. evaluation of pain and tolerability scores

    Time frame: 1 hour

    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.

  2. percentage of caecum intubation

    Time frame: 1 hour

  3. time to reach caecum

    Time frame: 1 hour

  4. Adenoma detection rate

    Time frame: 9 months

    Proportion of patients with at least one adenoma of any size

Sponsors and collaborators

Lead sponsor

Presidio Ospedaliero Santa Barbara

Other

Registry information

Official study title

Warm Water Colonoscopy: a Novel Method for Unsedated Colonoscopy

Acronym: WW

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 1, 2011
Registry last updated
Feb 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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