Study to Analyse the Use of a Digital Platform for the Preparation and Follow-up of Patients With Scheduled Outpatients Colonoscopy (COLObs)

Persei Vivarium

Status: Enrolling

Conditions: Outpatient Colonoscopy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06916052

COLObs

Details and patient eligibility

About

The goal of this clinical trial investigation with device is to to analyze the use of the Caaring® digital platform for the preparation and follow-up of scheduled colonoscopy.

Colonoscopy is a difficult procedure, and it is estimated that bowel preparation is inadequate in about 25% of patients. The main question it aims to answer is if the use of a digital platform (Caaring®) could be an effective tool for reducing the percentage of inadequate bowel preparations in patients with a scheduled colonoscopy. To this end, the application will provide precise instructions to patients.

A prospective, single-center, observational study with software device: The recruitment phase is expected to last two months. Patients will be followed for one month after the colonoscopy and 14 days prior to it.

Additionally, measuring patient experience and monitoring adverse effects after a colonoscopy are crucial to improving the safety of colonoscopies and the quality of healthcare, promoting higher quality colonoscopy services.

For that to happen, participants must have sufficient technological skills to use a smartphone.

Full description

A prospective, single-center, observational study with software device. The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki.

Enrollment: 225 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older.
• Signed informed consent.
• Patients scheduled for outpatient colonoscopy.
• Patients able to complete the study questionnaires.
• Patients who regularly use a smartphone

Exclusion criteria

• Patients enrolled in the population-based colorectal cancer screening program with a positive fecal occult blood test.
• Minors or elderly patients (over 80 years of age).
• Patients with prior colorectal surgery.
• Patients who, in the opinion of the researcher, will not be able to commit to follow-up or lack adequate technological skills.
• Inability to provide adequate informed consent.