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Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients

NCT ID: NCT00660296

Last Updated: 2008-04-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-10-31

Brief Summary

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CO2 insufflation instead of air for colonic distension in colonoscopy is considered to reduce pain after and during colonoscopy. There is limited data, that Co2 is similar effective in sedated patients. Furthermore it had not been investigated if patient's compliance for participating in cancer screening could be improved by using Co2.

The aim of the study is to assess postoperative pain and satisfaction after colonoscopy by comparing C02 with air.

Detailed Description

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Conditions

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Pain, Satisfaction

Keywords

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CO2 pain colonoscopy cancer screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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2

Air insufflation in colonoscopy

Group Type OTHER

Air insufflation use in colonoscopy

Intervention Type OTHER

Air insufflation for colonic distension

1

CO2 insufflation in colonoscopy

Group Type OTHER

CO2 use in colonoscopy

Intervention Type OTHER

Co2 insufflation for colonic distension

Interventions

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Air insufflation use in colonoscopy

Air insufflation for colonic distension

Intervention Type OTHER

CO2 use in colonoscopy

Co2 insufflation for colonic distension

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients, who are assigned to an outdoor ambulance for elective colonoscopy in sedation
* Between 18 and 90 years

Exclusion Criteria

* COPD
* Dementia
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Vienna

Principal Investigators

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Stefan Riss, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Anton Weiser, MD

Role: PRINCIPAL_INVESTIGATOR

Ärztezentrum Ost, Anton Baumgartnerstrasse 44, 1230 Vienna

Locations

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Dr. Anton Friedrich Weiser

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Stefan Riss, MD

Role: CONTACT

Phone: 43-40-400-5621

Email: [email protected]

Facility Contacts

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Anton Weiser, MD, MSc

Role: primary

References

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Bretthauer M, Lynge AB, Thiis-Evensen E, Hoff G, Fausa O, Aabakken L. Carbon dioxide insufflation in colonoscopy: safe and effective in sedated patients. Endoscopy. 2005 Aug;37(8):706-9. doi: 10.1055/s-2005-870154.

Reference Type RESULT
PMID: 16032487 (View on PubMed)

Other Identifiers

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EK 07-238-VK

Identifier Type: -

Identifier Source: org_study_id