- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01675739
Effectiveness of Fixed PC Interval Using SMS for Afternoon Colonoscopy
Effectiveness of Fixed Preparation-to-Colonoscopy Interval Using Short Message Service (SMS) for Afternoon Colonoscopy: a Randomized Control Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Busan, Korea, Republic of, 612-030
- Department of Internal Medicine, Haeundae Paik Hospital, Inje University, College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 and 80 years who were scheduled for afternoon colonoscopy (screening or surveillance)
Exclusion Criteria:
- unavailable mobile phone nor SMS
- age younger than 18 years
- pregnancy
- breastfeeding
- history of large-bowel resection
- renal failure (serum creatinine ≥ 3.0 mg/dL [normal 0.8-1.4])
- drug addiction or major psychiatric illness
- allergy to PEG
- refusal to participate in the study.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: No-SMS group
In No-SMS group took 1st 2L of PEG solution at 6-8 PM on the day before colonoscopy and started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy without SMS.
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No-SMS group took 1st 2L of PEG solution at 6-8 PM on the day before colonoscopy and started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy. SMS group took 1st 2L PEG as same manner of No-SMS group and then started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy after receiving scheduled SMS
Other Names:
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Experimental: SMS group
Patients in SMS group took 1st 2L PEG as same manner of No-SMS group and then started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy after receiving scheduled short message service(SMS)
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No-SMS group took 1st 2L of PEG solution at 6-8 PM on the day before colonoscopy and started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy. SMS group took 1st 2L PEG as same manner of No-SMS group and then started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy after receiving scheduled SMS
Other Names:
In SMS group, patients took 1st dose polyethylene glycol (PEG) 2L at 6-8pm the day before colonoscopy and then start to take 2nd dose PEG 2L after receiving Short message service of mobile phone (SMS) 6hours before afternoon colonoscopy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the Ottawa bowel preparation scale
Time Frame: at the end of time of the colonoscopic examination (about 30 minutes-1hour)
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This scale assesses cleanliness and fluid volume respectively and presents the total score as sum of these two values.
Cleanliness was assessed for the right colon (cecum, ascending colon), midcolon (transverse, descending colon), and the rectosigmoid colon; each colon section was individually rated from 0 to 4 (0 = no liquid, 1 = minimal liquid, no suction required, 2 = suction required to see mucosa, 3 = wash and suction required, 4 = solid stool, not washable).
Fluid quantity was rated from 0 to 2 for the entire colon (0 = minimal, 1 = moderate, 2 = large).
The Ottawa Scale scores range from 0 (perfect) to 14 (solid stool in each colon segment and large amount of fluid).
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at the end of time of the colonoscopic examination (about 30 minutes-1hour)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tae Oh Kim, Department of Internal Medicine, Haeundae Paik Hospital, Inje University, College of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SMS-CFS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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