Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy

This study has been terminated.
(Study terminated due to FDA alert regarding Fleet phosphosoda)
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00558376
First received: November 13, 2007
Last updated: May 4, 2009
Last verified: May 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy - An Investigator Blinded Prospective Controlled Trial

Resource links provided by NLM:


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 ]

Enrollment: 23
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Ingestion of 3L polyethylene Glycol
Drug: polyethylene glycol
Single time 3 liters PEG, 250 cc every 15 minutes the day before colonoscopy
Other Name: Meroken New, Polyethylene glycol 3350, Taro, Israel
Active Comparator: 2
Ingestion of 2 doses of sodium phosphate 45 cc
Drug: Sodium phosphate
Sodium phosphate 45cc, 2 doses 4 hours apart the day before colonoscopy
Other Name: Sodium phosphate solution; Soffodex, Dexxon, Israel

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558376

Locations
Israel
Sheba_Medical_Center
Tel-Hashomer, Israel, 52961
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

No publications provided

Responsible Party: Shomron Ben-Horin, Sheba Medical center
ClinicalTrials.gov Identifier: NCT00558376     History of Changes
Other Study ID Numbers: SHEBA-07-4884-SBH-CTIL
Study First Received: November 13, 2007
Last Updated: May 4, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Colonoscopy

ClinicalTrials.gov processed this record on October 29, 2014