Randomized Controlled Trial Comparing Co2 vs. Air in Colo... | NCT00660296

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

NCT00660296

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Apr 17, 2008Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Pain, Satisfaction

Interventions

Air insufflation use in colonoscopy
CO2 use in colonoscopy

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Oct 2008Estimated

Completion Date

Oct 2008Estimated

First Submitted Date

Apr 14, 2008

First Submission Date that Met QC Criteria

Apr 16, 2008

First Posted Date

Apr 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2008

Last Update Posted Date

Apr 17, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Other	Air insufflation in colonoscopy	Other: Air insufflation use in colonoscopy
1	Other	CO2 insufflation in colonoscopy	Other: CO2 use in colonoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Air insufflation use in colonoscopy	Other	Air insufflation for colonic distension	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain after Colonoscopy measured by 100mm visual analogue scale.		15 and 30 minutes and 6 h and 12 h after colonoscopy

Secondary Outcomes

Measure	Description	Time Frame
patients satisfaction (VAS) and its benefit in regard to cancer screening (2 questions)		30 minutes and 6 hours after colonoscopy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefan Riss, MD	Contact	43-40-400-5621		stefan.riss@meduniwien.ac.at

Overall Officials

Name	Affiliation	Role
Stefan Riss, MD	Medical University of Vienna	Principal Investigator
Anton Weiser, MD	Ärztezentrum Ost, Anton Baumgartnerstrasse 44, 1230 Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Anton Friedrich Weiser	Recruiting	Vienna	State of Vienna	1230	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16032487	Result	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.

ID	Term
D010146	Pain
D010549	Personal Satisfaction
D009369	Neoplasms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001519	Behavior

ID	Term
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures