Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease

Overview

Clinical trial evaluating efficacy of bowel cleansing solutions in patients with Inflammatory Bowel Disease.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2021

Detailed Description

Simple blind, randomized study evaluating efficacy of 1LPEG vs 2L PEG vs 2L sodium picosulfate in bowel cleansing of patients diagnosed of Inflammatory Bowel Disease undergoing diagnostic or follow-up routine colonoscopy.

Interventions

  • Procedure: Endoscopy
    • Colonoscopy

Arms, Groups and Cohorts

  • Active Comparator: 1L PEG
  • Active Comparator: 2L PEG
  • Active Comparator: 2L sodium picosulfate

Clinical Trial Outcome Measures

Primary Measures

  • Bowel cleansing
    • Time Frame: 1 year
    • Boston Bowel Preparation Score (BBPS), a 10-point scale assessing bowel preparation after all cleansing maneuvers are completed by the endoscopist. Each region of the colon receives a “segment score” from 0 to 3 and these segment scores are summed for a total BBPS score ranging from 0 to 9. Therefore, the maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0.

Secondary Measures

  • Treatment related adverse events
    • Time Frame: 1 year
    • Number of Participants with symptomatology related to intervention in each arm of the study
  • Preparation Tolerability: total volume of solution finally taken by the patient
    • Time Frame: 1 year
    • Evaluation of total volume of solution finally taken by the patient

Participating in This Clinical Trial

Inclusion Criteria

  • Patients between 18y and 90y – Patients with a diagnosis of IBD undergoing follow-up or screening colonoscopy Exclusion Criteria:

  • Patients <18y or >90y – Pregnant Women – Patients with a past history of inadequate bowel cleansing in a colonoscopy performed in the previous 12 months prior to initiation of study – Patients with a history of bowel resection – Patients undergoing therapeutic colonoscopy – Patients unable to understand study protocol

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hospital Universitario La Paz
  • Provider of Information About this Clinical Study
    • Principal Investigator: María Dolores Martín Arranz, PhD, Principal Investigator – Hospital Universitario La Paz
  • Overall Official(s)
    • Maria Dolores Martin Arranz, PhD, Principal Investigator, Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.

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