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The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients

NCT ID: NCT01415076

Last Updated: 2012-09-05

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-06-30

Brief Summary

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Insufflation of carbon dioxide (CO2) instead of air can reduce pain resulting from colon distension after colonoscopy because CO2 is rapidly absorbed from the colon and excreted through the lungs. This reduces the effects of colonic distension and minimizes intracolonic gas at the end of the examination. The aims of the study were to evaluate the timing of administering CO2 insufflation and to identify predictors of discomfort for colonoscopy.

Detailed Description

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Conditions

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Outpatients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Insertion without CO2 insufflation

Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.

Group Type PLACEBO_COMPARATOR

Insufflation with CO2

Intervention Type PROCEDURE

Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.

Insertion with CO2

Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.

Group Type EXPERIMENTAL

Insufflation with CO2

Intervention Type PROCEDURE

Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.

Interventions

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Insufflation with CO2

Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.

Intervention Type PROCEDURE

Other Intervention Names

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the Olympus UCR Endoscopic CO2 Regulation Unit

Eligibility Criteria

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Inclusion Criteria

* patients with an appropriate indication for colonoscopy were considered eligible.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peng-Jen Chen

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tsai-Yuan Hsieh, MD.PhD

Role: STUDY_CHAIR

Division of Gastroenterology, Tri-Service General Hospital

Locations

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Division of Gastroenterology, Tri-Service General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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TSGH-C99-062

Identifier Type: -

Identifier Source: org_study_id