Carbon Dioxide Insufflation (CO2) and Warm Water Infusion (WWI) Versus Standard Air Insufflation (AI) for Unsedated Colonoscopy

NCT ID: NCT01259583

Last Updated: 2013-03-13

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

NA

Total Enrollment

341 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-12-31

Brief Summary

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Due to the increasing demand for colonoscopy in clinical practice, great interest has recently renewed for unsedated colonoscopy. Both Carbon dioxide Insufflation (CO2) and Warm Water Infusion (WWI) have been advocated to improve patient tolerance for colonoscopy as compared to standard Air Insufflation (AI). This study is aimed at evaluating the performance of the above techniques versus AI in unsedated patients.

Detailed Description

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Conditions

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Warm Water CO2 Colonoscopy Unsedated Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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CO2

CO2 insufflation instead air insufflation in unsedated colonoscopy

Group Type EXPERIMENTAL

CO2

Intervention Type PROCEDURE

CO2 insufflation

Warm Water irrigation

warm water irrigation during the insertion phase of colonoscopy

Group Type EXPERIMENTAL

Warm water

Intervention Type PROCEDURE

warm water irrigation

Interventions

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CO2

CO2 insufflation

Intervention Type PROCEDURE

Warm water

warm water irrigation

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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Arnaldo Amato

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Valduce Hospital - Gastroenterology Department

Como, , Italy

Site Status

Countries

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Italy

References

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Amato A, Radaelli F, Paggi S, Baccarin A, Spinzi G, Terruzzi V. Carbon dioxide insufflation or warm-water infusion versus standard air insufflation for unsedated colonoscopy: a randomized controlled trial. Dis Colon Rectum. 2013 Apr;56(4):511-8. doi: 10.1097/DCR.0b013e318279addd.

Reference Type DERIVED
PMID: 23478620 (View on PubMed)

Other Identifiers

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CO2-01

Identifier Type: -

Identifier Source: org_study_id

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