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

NCT00558376 | Terminated

• 1 other identifier: SHEBA-07-4884-SBH-CTIL
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colonoscopy

Keywords

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Colon cleanliness at the second colonoscopy

  within 24 hours of purgative ingestion, and within 30 minutes of colonoscopy

Secondary Outcomes (1)

• Tolerability of purgative regimen

  within 24 hours of purgative ingestion

Study Arms (2)

1

ACTIVE COMPARATOR

Ingestion of 3L polyethylene Glycol

Drug: polyethylene glycol

2

ACTIVE COMPARATOR

Ingestion of 2 doses of sodium phosphate 45 cc

Drug: Sodium phosphate

Interventions

polyethylene glycol DRUG

Single time 3 liters PEG, 250 cc every 15 minutes the day before colonoscopy

Also known as: Meroken New, Polyethylene glycol 3350, Taro, Israel

1

Sodium phosphate DRUG

Sodium phosphate 45cc, 2 doses 4 hours apart the day before colonoscopy

Also known as: Sodium phosphate solution; Soffodex, Dexxon, Israel

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba_Medical_Center

Tel Litwinsky, 52961, Israel

Location

MeSH Terms

Interventions

Polyethylene Glycols; polyethylene glycol 3350; sodium phosphate

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Shomron Ben-Horin, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Benjamin Avidan, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: January 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

IL (1)