Warm Water for Unsedated Colonoscopy (WW)

September 15, 2011 updated by: Vittorio Terruzzi, Valduce Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CO
      • Como, CO, Italy, 22100
        • Valduce Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: warm water
warm water irrigation during the insertion phase of colonoscopy
Procedure: warm water irrigation
warm water irrigation during insertion phase of colonoscopy
Active Comparator: air
air insufflation during the insertion phase of colonoscopy
Procedure: air insufflation
air insufflation during the insertion phase of colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients Undergoing Complete Unsedated Colonoscopy
Time Frame: 6-9 months
6-9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valduce Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

May 15, 2009

First Submitted That Met QC Criteria

May 18, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Estimate)

October 25, 2011

Last Update Submitted That Met QC Criteria

September 15, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WW01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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