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Written Recommendation to Improve Adherence in Poor Bowel Preparation

NCT05709145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2025-01-15

No results posted yet for this study

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.

Conditions

  • Colonic Disease
  • Adherence, Patient

Interventions

OTHER

Written recommendation

Patients in the intervention group will receive a report of the colonoscopy that will include a written recommendation that the colonoscopy should be repeated within1 year. The colonoscopy report will included that an adequate intestinal cleansing has not been achieved and therefore it is an invalid exploration. Additionally, a written recommendation indicating that the colonoscopy should be repeated within1 year will be included in the colonoscopy report. This recommendation is addressed both to the clinician who requested the colonoscopy and to the patient himself.

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-11
Primary Completion
2024-12-31
Completion
2025-01-13

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05709145 on ClinicalTrials.gov