Warm Water and Unsedated Colonoscopy

NCT ID: NCT01463319

Last Updated: 2013-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

818 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Diseases Digestive System Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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warm water irrigation

warm water irrigation during insertion phase of colonoscopy

Group Type EXPERIMENTAL

warm water irrigation

Intervention Type OTHER

warm water irrigation during insertion phase colonoscopy

air insufflation

air insufflation during insertion phase of colonoscopy

Group Type EXPERIMENTAL

air insufflation

Intervention Type OTHER

air insufflation during insertion phase colonoscopy

Interventions

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air insufflation

air insufflation during insertion phase colonoscopy

Intervention Type OTHER

warm water irrigation

warm water irrigation during insertion phase colonoscopy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Presidio Ospedaliero Santa Barbara

OTHER

Sponsor Role lead

Responsible Party

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Sergio Cadoni, M.D.

Responsabile Servizio Endoscopia Digestiva

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sergio Cadoni, M.D.

Role: PRINCIPAL_INVESTIGATOR

A.S.L. 07 Sardegna

Locations

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Servizio Endoscopia Digestiva

Iglesias, Carbonia-Iglesias, Italy

Site Status

U.O.S.D. Diagnostica e Terapia Endoscopica

San Gavino Monreale, Medio Campidano (VS), Italy

Site Status

Countries

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Italy

Other Identifiers

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ASL07_WW-2011

Identifier Type: -

Identifier Source: org_study_id

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