Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy

Overview

Patients intended for ambulatory colonoscopy will be randomized into 2 groups

Full Title of Study: “Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy, a Prospective Randomized, Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Care Provider)

Interventions

  • Drug: Sodium Picosulphate
    • 2 Sachets
  • Drug: Polyethylene Glycol
    • 3 Liters solution

Arms, Groups and Cohorts

  • Active Comparator: Polyethylene glycol
    • Preparation with Polyethylene Glycol and bisacodyl
  • Experimental: Picolax
    • Preparation with Sodium Picosulphate and Bisacodyl.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of patients requiring repeat colonoscopy because of poor preparation
    • Time Frame: quality of preparation will be assessed during colonoscopy
    • Quality of preparation: good, moderate, poor

Secondary Measures

  • Patient’s satisfaction as measured by questionnaire and willingness to repeat same preparation on future examination
    • Time Frame: Questionnaire will be filled before colonoscopy
    • Patient satisfaction on questionnaire referring to taste, compliance with protocol, side effects, willingness to repeat preparation.

Participating in This Clinical Trial

Inclusion Criteria

  • Ambulatory patients scheduled for elective colonoscopy – Age 18-80 Exclusion Criteria:

  • Renal insufficiency (serum creatinine ≥2.0 mg/dl) – Symptomatic congestive heart failure – Recent myocardial infarction

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rabin Medical Center
  • Provider of Information About this Clinical Study
    • Eyal Gal MD, Rabin Medical Center- Beilinson hospital
  • Overall Official(s)
    • Eyal Gal, MD, Principal Investigator, Rabin Medical Center – Beilinson hospital

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