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TerminatedNCT00558376Updated Jun 14, 2018

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

An interventional study of polyethylene glycol and Sodium phosphate in Colonoscopy, sponsored by Sheba Medical Center. Terminated at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-06-14.

Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment

Why this study was terminated
Study terminated due to FDA alert regarding Fleet phosphosoda
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colonoscopy

Keywords

  • Colonoscopy
03

In context

Lead sponsor

Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
23 participants (actual)

Study arms

  • Active comparator
    1

    Ingestion of 3L polyethylene Glycol

    Drug: polyethylene glycol

  • Active comparator
    2

    Ingestion of 2 doses of sodium phosphate 45 cc

    Drug: Sodium phosphate

Interventions

  • Drugpolyethylene glycol

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

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

  • DrugSodium phosphate

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

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

06

What researchers measure

Primary outcomes

  1. Colon cleanliness at the second colonoscopy

    Time frame: within 24 hours of purgative ingestion, and within 30 minutes of colonoscopy

Secondary outcomes

  1. Tolerability of purgative regimen

    Time frame: within 24 hours of purgative ingestion

07

Study locations

1 site
  • Sheba_Medical_Center
    Tel-Hashomer, 52961, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00558376
Lead sponsor
Sheba Medical Center
Responsible party
Prof. Shomron BenHorin (Professor, Sheba Medical Center) — Principal investigator
First posted
Nov 14, 2007
Start date
Jan 2008
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Jun 14, 2018

Study contacts

Shomron Ben-Horin, MD
principal investigator · Sheba Medical Center
Benjamin Avidan, MD
principal investigator · Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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