Improvement of Colonoscopy Preparation by Using a SPA

Overview

This study evaluates the impact of a SPA on Quality of bowel preparation for colonoscopy. Half of the patients receive regular paper based information on colonoscopy preparation (control), while the other half will use an additional SPA for colonoscopy preparation (coloprAPP).

Full Title of Study: “Evaluation of Improvement of Colonoscopy Preparation by Using a SPA”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Care Provider, Investigator)
  • Study Primary Completion Date: March 30, 2019

Detailed Description

Preparation for colonoscopy is perceived as a major impediment to participate in CRC screening colonoscopy. Hence, inadequate bowel preparation is reported in up to 25% of all patients undergoing colonoscopy. Although the quality of bowel preparation is influenced by various factors, it largely depends on patient´s compliance regarding instructions on purgatives and diet. Therefore reinforced education and guidance is a valuable tool to improve bowel preparation. A rapidly increasing number of individuals worldwide use smartphones in their daily life. Application of this new technology into patient education could facilitate and empower the patient guidance. In this study patients either receive regular information on colonoscopy preparation (paper-based) or download a SPA for reinforced reminding of the steps of colonoscopy preparation. Objective of this study is to measure the impact of a SPA on quality of bowel preparation.

Interventions

  • Device: ColoprAPP
    • Additional downloaded SPA for reminding the crucial steps of colonoscopy preparation

Arms, Groups and Cohorts

  • No Intervention: Control group
    • Regular colonoscopy preparation paper based information provided
  • Other: ColoprAPP group
    • Regular colonoscopy preparation paper based information provided plus usage of a downloaded SPA (ColoprAPP) as a reminder system for colonoscopy preparation

Clinical Trial Outcome Measures

Primary Measures

  • Quality of Bowel preparation
    • Time Frame: During colonoscopy procedure
    • Measurement of bowel cleanliness by Boston Bowel preparation Scale (BBPS) with special regard on percentage of insufficient results of bowel preparation

Secondary Measures

  • Adenoma detection rate
    • Time Frame: histological analysis after colonoscopy up to 10 days (d10)
    • Rate of adenoma detected and resected during colonoscopy
  • Acceptance of patients towards bowel preparation procedure
    • Time Frame: at colonoscopy appointment (day 0)
    • Measurement of patient satisfaction and acceptance with colonoscopy preparation procedure rated by numeric Rating scale

Participating in This Clinical Trial

Inclusion Criteria

  • smartphone – outpatient appointment for colonoscopy – CRC Screening, surveillance – <ASA 3 Exclusion Criteria:

  • no smartphone – >ASA 3 (no possibility for outpatient colonoscopy)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Ulm
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alexander Meining, Head of Endoscopy department – University of Ulm
  • Overall Official(s)
    • Benjamin M Walter, MD, Principal Investigator, Universitätsklinikum Ulm
  • Overall Contact(s)
    • Benjamin M Walter, MD, 0049-731-500-44818, Benjamin.walter@uniklinik-ulm.de

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