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

Sheba Medical Center

Status: Terminated

Conditions: Colonoscopy

Treatments: Drug: Sodium phosphate; Drug: polyethylene glycol

Study type: Interventional

Funder types: Other

Identifiers

NCT00558376

SHEBA-07-4884-SBH-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups

1

Active Comparator group

Description:

Ingestion of 3L polyethylene Glycol

Treatment:

Drug: polyethylene glycol

2

Active Comparator group

Description:

Ingestion of 2 doses of sodium phosphate 45 cc

Treatment:

Drug: Sodium phosphate