A Mobile Application to Improve the Quality of Colonoscopy in Colorectal Cancer Screening Program (PrepColon APP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-74
SponsorHospital del Rio Hortega
About this trial
Colonoscopy is the gold standard for the diagnosis and resection of preneoplastic lesions, allowing the prevention of colon cancer. A colonoscopy is more efficient with proper preparation of the colon, as it allows for a higher rate of adenoma detection and cecal intubation. In routine practice, up to 30% of colonoscopies are poorly prepared and 11% of patients do not show up for their appointment. Adenomas not visualized in the initial colonoscopy due to poor preparation reached 68% and the rate of undetected cancers was 66.7%. A proper colon cleanse is conditioned by different factors; among them, failure to comply with the diet and take laxatives poses 5 times the risk of having a deficient colon preparation. The purpose of our study is the design and implementation of an app that facilitates the preparation of colonoscopy and evaluates its impact on compliance with diet and laxative intake.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
-Subjects between 50-69 years old from the CRC screening program with FIT (>100ng/ml).
Informed consent granted in writing
Disqualifiers
Refusal to give informed consent.
Those who do not have a smartphone with a minimum version of the operating system (Android 4.4 or iOS 14, which cover more than 99% of the terminals in use)
Symptomatic patients
Subjects at elevated risk of CRC due to family history or inherited polyposis diseases or inflammatory bowel disease
Trial design
Design model
Parallel
Treatments tested in this trial
Mobile application for colonoscopy preparation instructions
Other interventionThe APP will also consider the comorbidities and drugs of each patient. It can be adapted to the different types of laxative (4, 2 or 1 litre) and notify the need to discontinue anticoagulant and/or antiplatelet treatments by contacting with the primary care physician. Additionally, the application may ask short questions to the patient to control the laxative intake instruction. The user must confirm the appointment 48 hours in advance.
Treatment groups
470 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: APP groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Compliance with the diet and intake of laxatives with the use of a mobile application
Questionnaire about ASSESSMENT OF DIET COMPLIANCE (number of portions 0-\>2, higher points means worse outcome): Have you followed the diet without fiber the 3 days prior to preparation: YES/ NO * Have you eaten fruits, vegetables and legumes? number of portions 0 1 2 \>2 * Have you eaten whole grain products? number of portions 0 1 2 \>2 * Have you eaten meats and sausages? number of portions 0 1 2 \>2 * Have you eaten blue fish? number of portions 0 1 2 \>2 * Have you eaten nuts? number of portions 0 1 2 \>2 * Have you eaten anything solid in the last 24 hours? yes/ no
Time frame
at the moment of the procedure2
Evaluate the quality of colon cleansing with mobile application as an experimental factor
The endoscopy will assess colon cleansing according to the Boston Bowel Scale (BBPS) uses a 4-point rating system (0-3) applied to each of the 3 segments of the colon (right, transverse, left) to assess colon cleanliness during the withdrawal phase of colonoscopy, after all cleaning maneuvers have been performed. (0 worse outcome and 3 best outcome)
Time frame
at the moment of the procedure3
Assessment of the usability of the APP
A questionare: System Usability scale (SUS), ten question about usability with Five responses ranging from Strongly Agree to Strongly Disagree
Time frame
at the moment of the procedure4
Compliance with the laxative intake with the use of the mobile application
Questionnaire to EVALUATE COMPLIANCE WITH TAKING THE LAXATIVE: questions like at • --Type of laxative: (name): * Colonoscopy appointment (time) Morning / Afternoon * Start of taking the laxative: time: * End of taking the laxative (How many hours ago did you finish taking the laxative before the appointment? * Have you taken all of the laxative? * How much liquid have you drunk? * How many shots have you done it in? How much liquid does each drink?
Time frame
At the moment of the procedureSecondary outcomes
1
Assessment of the difficulty of the preparation instructions
quesionnaire: EVALUATION OF THE COMPRESSION OF THE INSTRUCTIONS GIVEN: scale from 0 to 10 (0:worse outcomes and 10: best outcomes)
Time frame
at the moment of the procedure2
Evaluate colonoscopy quality indicators:
Adenoma detection rate (ADR) is the percentage of patients with at least one histologically proven adenoma or carcinoma
Time frame
at the moment of the procedure and after one month with the histological results3
Evaluate attendance at the scheduled colonoscopy appointment
Attendance or not to colonoscopy appointment
Time frame
at the moment of the colonoscopy4
Evaluate colonoscopy quality indicators
Cecal intubation rate is the percentage of patients with completed colonoscopy
Time frame
at the moment of the colonoscopySponsors and contacts
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Source ClinicalTrials.gov