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

March 24, 2010 updated by: Rabin Medical Center

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

Patients intended for ambulatory colonoscopy will be randomized into 2 groups

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach Tikva, Israel, 4910
        • Rabin Medical Center - Beilinson Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Polyethylene glycol
Preparation with Polyethylene Glycol and bisacodyl
Drug: Polyethylene Glycol
3 Liters solution
Other Names:
  • Meroken new
  • Go-Lytely
Experimental: Picolax
Preparation with Sodium Picosulphate and Bisacodyl.
Drug: Sodium Picosulphate
2 Sachets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
quality of preparation will be assessed during colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Questionnaire will be filled before colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Eyal Gal, MD, Rabin Medical Center - Beilinson Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Estimate)

March 25, 2010

Last Update Submitted That Met QC Criteria

March 24, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gal001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bowel Preparation

Clinical Trials on Polyethylene Glycol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe