Comparison of Bowel Cleansing Regimens Prior to Colonoscopy

Overview

The purpose of this study is to to compare two bowel preparation regimens of patients who will undergo colonoscopy, in terms of quality of bowel preparation and in terms of patient satisfaction.

Full Title of Study: “PRECOL2011-1: Sodium Picophosphate and Magnesium Citrate Versus Polyethylene Glycol as Evacuating Treatment Prior to Colonoscopy: Phase IV Randomized Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2024

Interventions

  • Drug: polyethylene glycole (PEG) solution
  • Drug: sodium picosulphate and magnesium citrate solution

Arms, Groups and Cohorts

  • Active Comparator: PEG
    • polyethylene glycol solution 2 liters
  • Active Comparator: NapP
    • Sodium picosulphate and magnesium citrate solution 300 ml

Clinical Trial Outcome Measures

Primary Measures

  • Boston Bowel Preparation Scale value
    • Time Frame: at time of colonscopy
    • evaluated by two endoscopists who are blinded to treatment assigned at randomization
  • patient reported acceptability score
    • Time Frame: just prior to colonscopy
    • using visual analog scale

Secondary Measures

  • percent of bowel cleansing regimen dose assumed as reported by patient
    • Time Frame: just prior to colonoscopy

Participating in This Clinical Trial

Inclusion Criteria

• Subjects who are candidate to undergo colonoscopy: Diagnosis Screening Follow-up after previous polypectomy

  • Informed consent – Age > 18 years Exclusion Criteria:

  • Previous colonic resection – Severe inflammatory bowel disease (IBD)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Cancer Institute, Naples
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Valentina D’Angelo, M.D., Principal Investigator, National Cancer Institute, Naples
    • Mario de Bellis, M.D., Principal Investigator, National Cancer Institute, Naples

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