Short Message Service in Colonoscopy Preparation (PERICLES-II-SMS)

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

Detailed Description
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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.

Official Title
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Improvement of Colonoscopy Preparation by New Media (SMS) (PERICLES-II-Study)

Conditions
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Colon Cancer

Intervention / Treatment
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* Procedure: Colonoscopy
* Device: mobile phone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years old written informed consent mobile phone user appointment for outpatient colonoscopy Exclusion Criteria: no outpatient colonoscopy no mobile phone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SMS receiving<br>Study participants of the SMS group receive in total 14 short messages (SMS) containing time adjusted information on colonoscopy preparation starting 4 days before colonoscopy appointment on their mobile phones. | Procedure: Colonoscopy<br>* Colonoscopy is performed in both study arm as standard examination<br>Device: mobile phone<br>* SMS received by mobile phone<br>|
| Active Comparator: Non-SMS receiving<br>Study participants of the Non-SMS-Group do not receive any SMS before colonoscopy. Preparation is done according to regular written information given to the patient. | Procedure: Colonoscopy<br>* Colonoscopy is performed in both study arm as standard examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel cleanness measured by Boston Bowel preparation Scale | Boston bowel preparation scale (BBPS) is measured by the endoscopist during colonoscopy | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | Histopathological analysis of polyps resected towards adenoma rate | 1 day | 
| Patient satisfaction and compliance | Patient´s satification with the colonoscopy preparation either SMS supported or not ist asked by a questionnaire | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Colonoscopy preparation, screening, New media, SMS, Short message service