RecruitingNot ApplicableNCT06314022

A Mobile Application to Improve the Quality of Colonoscopy in Colorectal Cancer Screening Program (PrepColon APP)

Design of a Mobile Application to Improve the Quality of Colonoscopy and Its Implementation in Colorectal Cancer Screening Program: a Randomized Multicenter Study (PrepColon APP Study)


Sponsor

Hospital del Rio Hortega

Enrollment

470 participants

Start Date

May 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 50 YearsMax Age: 74 Years

Inclusion Criteria2

  • Subjects between 50-69 years old from the CRC screening program with FIT (>100ng/ml).
  • Informed consent granted in writing

Exclusion Criteria4

  • 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

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Interventions

OTHERMobile 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.


Locations(2)

Hospital Universitario Rio Hortega

Valladolid, Valladolid, Spain

Hospital Universitario Rio Hortega

Valladolid, Valladolid, Spain

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NCT06314022


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