NCT01807312

Brief Summary

It has been reported that carbon dioxide (CO2) insufflation can reduce patient pain and abdominal discomfort during and after colonoscopy. Its safety and efficacy during colonoscopy even under sedation has been already assessed in some earlier trials. Air insufflation is still the standard method, however, due a lack of suitable replacement of equipment or technical improvement in colonoscopy. The investigators use radio frequency identification (RFID) technology to record the number of times and duration in the toilet of the patient after colonoscopy examination. These data may be proxies for discomfort. With application of CO2 insufflation, the times and duration in the toilet after examination will decrease as well as patient's discomfort after procedure, and further improvement of patient compliance can be anticipated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 27, 2013

Status Verified

August 1, 2013

Enrollment Period

5 months

First QC Date

March 6, 2013

Last Update Submit

August 26, 2013

Conditions

Carbon Dioxide Insufflation

Keywords

colonoscopy

Outcome Measures

Primary Outcomes (1)

  • The number of times and duration in the toilet of the patient after colonoscopy examination

    Two hours after examination

Secondary Outcomes (1)

  • the point of pain scoring system after colonoscopy examination

    Two hours after examination

Study Arms (2)

CO2 insufflation

EXPERIMENTAL

CO2 insufflations was applicated in routine colonoscopy examination with Endoscopic CO2 regulation unit and accessories

Device: Endoscopic CO2 regulation unit and accessories

Air insufflation

PLACEBO COMPARATOR

Air insufflations is applicated in Routine Colonoscopy Examination

Device: Placebo

Interventions

Endoscopic CO2 regulation unit and accessoriesDEVICE

Olympus UCR Endoscopic CO2 Regulation Unit

CO2 insufflation
PlaceboDEVICE
Air insufflation

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged between 20 and 80 years who receive Screening colonoscopy

You may not qualify if:

  • Subjects who have chronic lung diseases or cardiovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Location

Study Officials

  • Han-Mo Chiu, PhD

    Department of Internal Medicine, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2013

First Posted

March 8, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 27, 2013

Record last verified: 2013-08

Locations

TW(1)