An interventional study of Mobile application for colonoscopy preparation instructions in Colorectal Cancer and Premalignant Colon Lesions, sponsored by Hospital del Rio Hortega. Recruiting at 2 sites in Spain. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Hospital del Rio Hortega · Not applicable, Interventional, and Supportive care
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.
STUDY DESIGN AND METHODS
Study Design:
Phase 1: Design of the mobile application (APP): The APP will be designed in a participatory manner by the research team of the project, formed by doctors, nurses, statisticians and telecommunications engineers. The application should be usable with both Android and iOS devices, so we will use the Flutter framework to build apps for different platforms with a single code base.
When arranging a colonoscopy, the patient will install the APP on their mobile phone and indicate the date and time of the test. The APP will be responsible for supporting the preparation of the colon cleansing, for which, in addition to being able to visualize the corresponding information, it will make use of notifications to show diet reminders and laxative intakes.
More specifically, these could be some notifications:
The APP will also consider the comorbidities and drugs of each participant. 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 control the laxative intake instruction. The user must confirm the appointment 48 hours in advance. The design of the APP aims to be intuitive and easy to use by the target population (50-69 years), allowing to adapt the font size and zoom in on the images to facilitate the visualization of the information.
The APP will be multilingual for English and Spanish, and others may be incorporated if deemed necessary. An agile and iterative methodology of software development will be followed as SCRUM in the realization of the APP. Thus, sprints of about 3 weeks will be planned with delivery of functional software that will progressively incorporate the different functionalities planned for the APP.
Phase 2: Re-evaluation of the APP after the inclusion of 30 patients, the APP will be re-evaluated through a usability questionnaire and adjustments and changes will be made if necessary
Phase 3: Prospective, multicentre and randomized study in asymptomatic patients between 50 and 69 years who attend screening colonoscopy after a positive FIT >100 ng / ml)
The study will be carried out in the Digestive Service of 3 hospitals in Castilla y León: Virgen de la Concha Hospital in Zamora, Medina del Campo Hospital and Río Hortega University Hospital in Valladolid. Participants will be randomized into two groups according to the instructions given to perform the preparation of the colon prior to colonoscopy: group A: perform the preparation with the written instructions delivered in the consultation and group B: the investigators will give the instructions in writing and will also indicate how to install the APP to the participants.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 470 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Hospital del Rio Hortega is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
which receives the standard information given in writing,
Group which receives the standard information together with the mobile application individually adapted to the scheduled colonoscopy appointment and the type of laxative.
Other: Mobile application for colonoscopy preparation instructions
The 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.
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 procedure
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 procedure
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 procedure
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 procedure
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 procedure
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 results
Evaluate attendance at the scheduled colonoscopy appointment
Attendance or not to colonoscopy appointment
Time frame: at the moment of the colonoscopy
Evaluate colonoscopy quality indicators
Cecal intubation rate is the percentage of patients with completed colonoscopy
Time frame: at the moment of the colonoscopy
Plan to share: No
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Dec 2026, 31 months after the start.
Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 31 months is close to that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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Hospital del Rio Hortega