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Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy
This study is currently recruiting participants.
Verified by Sheba Medical Center, June 2008
Sponsored by: Sheba Medical Center
Information provided by: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00558376
  Purpose

The aim of the study is to compare the efficacy of Polyethylene glycol versus sodium phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation with sodium phosphate for first colonoscopy. The hypothesis tested is whether there is advantage for substituting the purgative used, as compared to repeating the colonoscopy with the same purgative.Briefly, patients whose preparation was inadequate, will be allocated randomly to a group that will receive 3L Polyethylene glycol versus a group that will receive sodium phosphate(45ccX2). Both groups will be instructed to extend low-fiber diet to 5 days. Cleanliness of the colon at colonoscopy will be assessed blindly by an experienced endoscopist.


Condition Intervention
Colonoscopy
Drug: polyethylene glycol
Drug: Sodium phosphate

Drug Information available for: Sodium phosphate, dibasic
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title: Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy - An Investigator Blinded Prospective Controlled Trial

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Colon cleanliness at the second colonoscopy [ Time Frame: within 24 hours of purgative ingestion, and within 30 minutes of colonoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability of purgative regimen [ Time Frame: within 24 hours of purgative ingestion ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Ingestion of 3L polyethylene Glycol
Drug: polyethylene glycol
Single time 3 liters PEG, 250 cc every 15 minutes the day before colonoscopy
2: Active Comparator
Ingestion of 2 doses of sodium phosphate 45 cc
Drug: Sodium phosphate
Sodium phosphate 45cc, 2 doses 4 hours apart the day before colonoscopy

Detailed Description:

The aim of the study is to compare the efficacy of Polyethylene glycol versus sodium phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation with sodium phosphate for first colonoscopy. The hypothesis tested is whether there is advantage for substituting the purgative used, as compared to repeating the colonoscopy with the same purgative.Briefly, the study will be composed of patients whose preparation was judged to be inadequate in a first colonoscopy by an endoscopist independent of the current study. They will be allocated randomly to a group that will receive 3L Polyethylene glycol versus a group that will receive sodium phosphate(45ccX2). Both groups will be instructed to extend low-fiber diet to 5 days. Cleanliness of the colon at colonoscopy will be assessed blindly by an experienced endoscopist.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Failed colonoscopy due to inadequate preparation
  • Able to understand and sign an informed consent
  • Preparation for frst colonoscopy consisted of sodium phosphate

Exclusion Criteria:

  • Significant heart disease or CHF
  • Chronic Renal Failure
  • Allergy to any of the purgative ingredients
  • Pregnancy
  • Alcohol and/or drug abuse
  • Vomiting or aspiration
  • Suspected bowel obstruction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558376

Contacts
Contact: Shomron Ben-Horin, MD 3-5303160 sben-horin@013.net.il

Locations
Israel
Sheba_Medical_Center Recruiting
Tel-Hashomer, Israel, 52961
Principal Investigator: Shomron Ben-Horin, MD            
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Shomron Ben-Horin, MD Sheba Medical Center
Principal Investigator: Benjamin Avidan, MD Sheba Medical Center
  More Information

Responsible Party: Sheba Medical center ( Shomron Ben-Horin )
Study ID Numbers: SHEBA-07-4884-SBH-CTIL
Study First Received: November 13, 2007
Last Updated: June 12, 2008
ClinicalTrials.gov Identifier: NCT00558376  
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Colonoscopy

Study placed in the following topic categories:
Sodium phosphate

Additional relevant MeSH terms:
Therapeutic Uses
Gastrointestinal Agents
Cathartics
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009