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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01415076
Date of registration: 10/08/2011
Prospective Registration: No
Primary sponsor: Tri-Service General Hospital
Public title: The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients
Scientific title: The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients
Date of first enrolment: September 2010
Target sample size: 200
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01415076
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research  
Phase:  N/A
Countries of recruitment
Taiwan
Contacts
Name:     Tsai-Yuan Hsieh, MD.PhD
Address: 
Telephone:
Email:
Affiliation:  Division of Gastroenterology, Tri-Service General Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- patients with an appropriate indication for colonoscopy were considered eligible.

Exclusion Criteria:

- Exclusion criteria included severe hematochezia, acute colonic pseudo-obstruction,
known obstructive lesions, age <18 years, prior colon resection, fulminant colitis,
chronic obstructive pulmonary disease requiring oxygen, and a medical history of CO2
retention. Patients that required only a partial colonoscopy or were unable to read
or understand Chinese were also excluded.



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Outpatients
Intervention(s)
Procedure: Insufflation with CO2
Primary Outcome(s)
abdominal pain during and after colonoscopy [Time Frame: One day]
Secondary Outcome(s)
colonoscopic cecal intubation time [Time Frame: One day]
loop formation [Time Frame: One day]
completeness of intubation [Time Frame: One day]
delayed bleeding [Time Frame: One day]
Secondary ID(s)
TSGH-C99-062
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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