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NCT05709145
Written Recommendation to Improve Adherence in Poor Bowel Preparation
Conditions: Colonic Disease, Adherence, Patient
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 342
Sponsor: Parc de Salut Mar
Summary
Our study aims to improve adherence to international clinical guidelines of repeating colonoscopy within 1 year, when bowel cleansing has failed.
To this end, we have designed an ambispective study in patients with inadequately prepared colonoscopy.
An intervention group to which a precise written recommendation on the need to repeat the colonoscopy in less than 1 year is attached, compared with a control group to which no written recommendations are provided.The sample size calculation is 171 patients per arm.
In addition, we will quantify the percentage of pre-malignant and malignant lesions detected at repeat colonoscopy.
We will also analyze factors that may be related to the recommendation or non-recommendation of repeat colonoscopy, as well as the association of variables related to adherence to repeat colonoscopy at an interval of less than 1 year.Through our study, we intend to demonstrate that a written recommendation, easily applicable and generalizable, has a positive impact on adherence to clinical follow-up guidelines in patients in whom bowel cleansing has failed.
Eligibility Criteria
Inclusion Criteria:Patients with a colonoscopy with inadequate bowel preparation for any indication except for colorectal cancer screeningExclusion Criteria:Patients with no indication for repeat colonoscopy due to clinical criteriaPatients with a recommendation to repeat the colonoscopy with a different intervalHospitalized patientsPatients with special reprogramming circuit (colorectal cancer screening, hospitalized patients, complex polypectomies, revision of polypectomies)Incomplete examination for other reasons than intestinal cleansing (stenosis, loops, etc...)Patients under 18 years of age
Source: ClinicalTrials.gov (NCT05709145). StuddyBuddy aggregates publicly available trial information.