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

Not Applicable

Completed

• Conditions: Colon Cancer
• Interventions: Procedure: Colonoscopy; Device: mobile phone

• Registration Number: NCT02272036
• Lead Sponsor: Technical University of Munich

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-22
• Study Start: 2015-12
• Primary Completion: 2017-02
• Status Verified: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-SMS receiving	Colonoscopy	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.
SMS receiving	mobile phone	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.
SMS receiving	Colonoscopy	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.

Primary Outcome Measures

Name	Time	Method
Bowel cleanness measured by Boston Bowel preparation Scale	1 day	Boston bowel preparation scale (BBPS) is measured by the endoscopist during colonoscopy

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Dr. Aschenbeck; 🇩🇪 Berlin, Germany

Gastroenterologische Praxis Prof. Leopold Ludwig; 🇩🇪 Dornstadt, Germany

2nd Medical Department, Klinikum rechts der Isar; 🇩🇪 Munich, Germany

II. Medizinische Klinik Krankenhaus Landshut-Achdorf; 🇩🇪 Landshut, Germany