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Warm Water for Unsedated Colonoscopy

NCT ID: NCT00905554

Last Updated: 2011-10-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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warm water

warm water irrigation during the insertion phase of colonoscopy

Group Type EXPERIMENTAL

warm water irrigation

Intervention Type PROCEDURE

warm water irrigation during insertion phase of colonoscopy

air

air insufflation during the insertion phase of colonoscopy

Group Type ACTIVE_COMPARATOR

air insufflation

Intervention Type PROCEDURE

air insufflation during the insertion phase of colonoscopy

Interventions

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warm water irrigation

warm water irrigation during insertion phase of colonoscopy

Intervention Type PROCEDURE

air insufflation

air insufflation during the insertion phase of colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valduce Hospital

OTHER

Sponsor Role lead

Responsible Party

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Vittorio Terruzzi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Valduce Hospital

Como, CO, Italy

Site Status

Countries

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Italy

References

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Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.

Reference Type DERIVED
PMID: 20883846 (View on PubMed)

Other Identifiers

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WW01

Identifier Type: -

Identifier Source: org_study_id