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OpenTrials
Completed

NCT Number: NCT00905554

Warm Water for Unsedated Colonoscopy

Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of drug-related side effects, although it may be painful for the patient. Based on recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of 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.

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Key information

Conditions

Colonoscopy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valduce Hospital

Como, CO, 22100, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult outpatients 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

warm water irrigation

Procedure

warm water irrigation during insertion phase of colonoscopy

air insufflation

Procedure

air insufflation during the insertion phase of colonoscopy

Primary outcomes

  1. Number of Patients Undergoing Complete Unsedated Colonoscopy

    Time frame: 6-9 months

Secondary outcomes

  1. Evaluation of Pain and Tolerability Scores

    Time frame: 6-9 months

    Entity of pain and tolerability level on a visual analogic scale (ranging from 0 - no pain, optimal tolerability - to 100 mm - worst pain ever, unbearable)

Sponsors and collaborators

Lead sponsor

Valduce Hospital

Other

Registry information

Official study title

Warm Water Irrigation Versus Standard Air Insufflation for Unsedated Colonoscopy: a Randomized Controlled Trial

Acronym: WW

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
May 20, 2009
Registry last updated
Oct 25, 2011

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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