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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01911052
Other study ID # 2013-05-050-002
Secondary ID
Status Completed
Phase Phase 3
First received July 22, 2013
Last updated July 16, 2014
Start date July 2013
Est. completion date February 2014

Study information

Verified date July 2014
Source Keimyung University Dongsan Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Inadequate bowel preparation results in decreased rates of cecal intubation, increased rates of missing important lesions, increased patient discomfort, higher risk of complications, prolonged procedure time and increased health-care cost. Recent study reported that Telephone-based re-education (TRE) on the day before colonoscopy significantly improved the quality of bowel preparation and polyp detection rate. However, there is no study to compare the effect of telephone with short message system (SMS) based re-education on the quality of bowel preparation in health screened population. Our goal is to improve the quality of bowel preparation with telephone or SMS based re-education for outpatients undergoing screening colonoscopies. The investigators hypothesise that efforts to improve education and maximise patient compliance during the preparatory period will enhance the efficacy of bowel preparation.


Recruitment information / eligibility

Status Completed
Enrollment 390
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 80 Years
Eligibility Inclusion Criteria:

- All health screened populations

- age >18

- scheduled for an elective screening colonoscopy

Exclusion Criteria:

- inpatients

- pregnancy

- breast feeding

- prior history of surgical large bowel resection

- patients allergic to PEG-ELS based laxatives

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Telephone based re-education
The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as telephone based re-education by one investigator on the day before colonoscopy.
Short message system based re-education
The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as short message system based re-education by one investigator on the day before colonoscopy.

Locations

Country Name City State
Korea, Republic of Eun Soo Kim Daegu

Sponsors (1)

Lead Sponsor Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Liu X, Luo H, Zhang L, Leung FW, Liu Z, Wang X, Huang R, Hui N, Wu K, Fan D, Pan Y, Guo X. Telephone-based re-education on the day before colonoscopy improves the quality of bowel preparation and the polyp detection rate: a prospective, colonoscopist-blinded, randomised, controlled study. Gut. 2014 Jan;63(1):125-30. doi: 10.1136/gutjnl-2012-304292. Epub 2013 Mar 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Patient compliance Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire baseline No
Primary Quality of bowel preparation The primary outcomes will be the endoscopist's assessment of the quality of preparation using Boston and Ottawa bowel preparation scare day 1 No
Secondary polyp detection rate The number of polyp prescribed by endoscopist. day 1 No
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