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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272036
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

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

Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: Colonoscopy Device: mobile phone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Improvement of Colonoscopy Preparation by New Media (SMS) (PERICLES-II-Study)
Study Start Date : December 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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




Primary Outcome Measures :
  1. Bowel cleanness measured by Boston Bowel preparation Scale [ Time Frame: 1 day ]
    Boston bowel preparation scale (BBPS) is measured by the endoscopist during colonoscopy


Secondary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: 1 day ]
    Histopathological analysis of polyps resected towards adenoma rate

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • over 18 years old
  • written informed consent
  • mobile phone user
  • appointment for outpatient colonoscopy

Exclusion Criteria:

  • no outpatient colonoscopy
  • no mobile phone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272036


Locations
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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, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Benjamin M Walter, MD Physician

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02272036    
Other Study ID Numbers: 102014
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017
Keywords provided by Technische Universität München:
Colonoscopy
Colonoscopy preparation
screening
New media
SMS
Short message service
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases