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

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

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.

Study Overview

• Status: Terminated
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: polyethylene glycol; Drug: Sodium phosphate

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel-Hashomer, Israel, 52961
    • Sheba_Medical_Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Sodium phosphate solution; Soffodex, Dexxon, Israel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Colon cleanliness at the second colonoscopy	within 24 hours of purgative ingestion, and within 30 minutes of colonoscopy

Secondary Outcome Measures

Outcome Measure	Time Frame
Tolerability of purgative regimen	within 24 hours of purgative ingestion

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Shomron Ben-Horin, MD, Sheba Medical Center; Principal Investigator: Benjamin Avidan, MD, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2008
• Primary Completion (ACTUAL): March 1, 2009
• Study Completion (ACTUAL): March 1, 2009

Study Registration Dates

• First Submitted: November 13, 2007
• First Submitted That Met QC Criteria: November 13, 2007
• First Posted (ESTIMATE): November 14, 2007

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Colonoscopy
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Laxatives; Polyethylene glycol 3350
• Other Study ID Numbers: SHEBA-07-4884-SBH-CTIL