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

April 19, 2017 updated by: Technical University of Munich

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Dr. Aschenbeck
      • Dornstadt, Germany
        • Gastroenterologische Praxis Prof. Leopold Ludwig
      • Landshut, Germany
        • II. Medizinische Klinik Krankenhaus Landshut-Achdorf
      • Munich, Germany, 81675
        • 2nd Medical Department, Klinikum rechts der Isar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SMS receiving
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
Colonoscopy is performed in both study arm as standard examination
Device: mobile phone
SMS received by mobile phone
Active Comparator: Non-SMS receiving
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
Colonoscopy is performed in both study arm as standard examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel cleanness measured by Boston Bowel preparation Scale
Time Frame: 1 day
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
Time Frame: 1 day
Histopathological analysis of polyps resected towards adenoma rate
1 day
Patient satisfaction and compliance
Time Frame: 1 day
Patient´s satification with the colonoscopy preparation either SMS supported or not ist asked by a questionnaire
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Benjamin M Walter, MD, Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

October 21, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102014

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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