Colon CancerPERICLES-IINCT02272036
Short Message Service in Colonoscopy Preparation (PERICLES-II-SMS)
A study testing Colonoscopy and mobile phone in people with Colon Cancer, run by Technical University of Munich at 4 sites in Germany.
Trial summary
The purpose of this study is to analyze if integration of new media (SMS) could improve the quality of colonoscopy preparation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Colonoscopy and mobile phone
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesGermany
- Study dates
- Dec 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years old
- written informed consent
- mobile phone user
- appointment for outpatient colonoscopy
Who cannot join
- no outpatient colonoscopy
- no mobile phone
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Dr. Aschenbeck
Berlin
Gastroenterologische Praxis Prof. Leopold Ludwig
Dornstadt
II. Medizinische Klinik Krankenhaus Landshut-Achdorf
Landshut
2nd Medical Department, Klinikum rechts der Isar
Munich, 81675
About this study
Official title: 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.
Read the 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.
- Conditions
- Colon Cancer
- Being tested
- Colonoscopy, mobile phone
- Keywords
- Colonoscopy, Colonoscopy preparation, screening, New media, SMS, Short message service
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Colonoscopy is performed in both study arm as standard examination
mobile phoneDevice
SMS received by mobile phone
| Study group | Role | What they receive |
|---|---|---|
| SMS receiving | Active comparator | 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. Receives: Procedure: Colonoscopy; Device: mobile phone |
| Non-SMS receiving | Active comparator | 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. Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel cleanness measured by Boston Bowel preparation Scale
Boston bowel preparation scale (BBPS) is measured by the endoscopist during colonoscopy
Measured: 1 day
Secondary outcomes (2)
Adenoma detection rate
Histopathological analysis of polyps resected towards adenoma rate
Measured: 1 day
Patient satisfaction and compliance
Patient´s satification with the colonoscopy preparation either SMS supported or not ist asked by a questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startDec 2015
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin M Walter, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272036
- Sponsor's protocol ID
- 102014
- Acronym
- PERICLES-II
- Status last verified
- Apr 2017
- First submitted
- 20 Oct 2014
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Walter B, Klare P, Strehle K, Aschenbeck J, Ludwig L, Dikopoulos N, Mayr M, Neu B, Hann A, Mayer B, Meining A, von Delius S. Improving the quality and acceptance of colonoscopy preparation by reinforced patient education with short message service: results from a randomized, multicenter study (PERICLES-II). Gastrointest Endosc. 2019 Mar;89(3):506-513.e4. doi: 10.1016/j.gie.2018.08.014. Epub 2018 Aug 21.
PubMed 30138612
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Colonoscopy Preparation by New Media (SMS) (PERICLES-II-Study)
- ClinicalTrials.gov ID
- NCT02272036
- Acronym / sponsor ID
- PERICLES-II / 102014
- Conditions
- Colon Cancer
- Keywords
- Colonoscopy, Colonoscopy preparation, screening, New media, SMS, Short message service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS receiving | Active comparator | Procedure: Colonoscopy, Device: mobile phoneStudy 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. |
| Non-SMS receiving | Active comparator | Procedure: ColonoscopyStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over 18 years old
- written informed consent
- mobile phone user
- appointment for outpatient colonoscopy
Key exclusion criteria (2 listed)
- no outpatient colonoscopy
- no mobile phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyColonoscopy is performed in both study arm as standard examination | Procedure or surgery | Non-SMS receiving, SMS receiving |
| mobile phoneSMS received by mobile phone | Device | SMS receiving |
Primary outcome
Bowel cleanness measured by Boston Bowel preparation Scale
Time frame: 1 day
Boston bowel preparation scale (BBPS) is measured by the endoscopist during colonoscopy
2 secondary outcomes
Adenoma detection rate
Time frame: 1 day
Patient satisfaction and compliance
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Derived from this study: PubMed 30138612Walter B, Klare P, Strehle K, Aschenbeck J, Ludwig L, Dikopoulos N, Mayr M, Neu B, Hann A, Mayer B, Meining A, von Delius S. Improving the quality and acceptance of colonoscopy preparation by reinforced patient education with short message service: results from a randomized, multicenter study (PERICLES-II). Gastrointest Endosc. 2019 Mar;89(3):506-513.e4. doi: 10.1016/j.gie.2018.08.014. Epub 2018 Aug 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin M Walter, MD principal investigator
Physician
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy and mobile phone in people with Colon Cancer, run by Technical University of Munich at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel cleanness measured by Boston Bowel preparation Scale (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02272036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017; AzTrials last refreshed its copy on 3 Nov 2026.