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

Colonoscopy Clinical Trial

Official title:

Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy - An Investigator Blinded Prospective Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00558376
• Other study ID #: SHEBA-07-4884-SBH-CTIL
• Status: Terminated
• Phase: N/A
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: June 2018
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• polyethylene glycol
Single time 3 liters PEG, 250 cc every 15 minutes the day before colonoscopy
• Sodium phosphate
Sodium phosphate 45cc, 2 doses 4 hours apart the day before colonoscopy

Locations

Country	Name	City	State
Israel	Sheba_Medical_Center	Tel-Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colon cleanliness at the second colonoscopy		within 24 hours of purgative ingestion, and within 30 minutes of colonoscopy
Secondary	Tolerability of purgative regimen		within 24 hours of purgative ingestion