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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02272036
Other study ID # 102014
Secondary ID
Status Completed
Phase N/A
First received October 20, 2014
Last updated April 19, 2017
Start date December 2015
Est. completion date April 2017

Study information

Verified date April 2017
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to analyze if integration of new media (SMS) could improve the quality of colonoscopy preparation.


Description:

The study approach is the implementation of new media into colonoscopy preparation. As most of our patients already use mobile phones the study should evaluate if time adjusted information about diet recommendation, laxative intake and behavioral recommedation improve the patient compliance and the quality of colonoscopy preparation. In total 14 SMS wil be sent to the study participants starting 4 days prior the colonoscopy appointment. No additional or different information is provided in comparison to regular colonoscopy preparation for out-patient colonoscopy.

Study participant are randomized when included into the study. Group 1 receives a SMS- supported colonoscopy preparation, group 2 receive no SMS and prepares regularly.

Primary endpoint is bowel cleanness measured by Boston Bowel preparation scale, secondary endpoints are patient satisfaction, adenoma detection rate and compliance.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date April 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- over 18 years old

- written informed consent

- mobile phone user

- appointment for outpatient colonoscopy

Exclusion Criteria:

- no outpatient colonoscopy

- no mobile phone

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Colonoscopy
Colonoscopy is performed in both study arm as standard examination
Device:
mobile phone
SMS received by mobile phone

Locations

Country Name City State
Germany Dr. Aschenbeck Berlin
Germany Gastroenterologische Praxis Prof. Leopold Ludwig Dornstadt
Germany II. Medizinische Klinik Krankenhaus Landshut-Achdorf Landshut
Germany 2nd Medical Department, Klinikum rechts der Isar Munich

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bowel cleanness measured by Boston Bowel preparation Scale Boston bowel preparation scale (BBPS) is measured by the endoscopist during colonoscopy 1 day
Secondary Adenoma detection rate Histopathological analysis of polyps resected towards adenoma rate 1 day
Secondary Patient satisfaction and compliance Patient´s satification with the colonoscopy preparation either SMS supported or not ist asked by a questionnaire 1 day
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