Comparison of Two Methods of Bowel Preparation for Colonoscopy in Hospitalized Patients

Cook County Health

Status: Completed

Conditions: Bowel Preparation for Colonoscopy

Treatments: Other: Split-dose polyethylene glycol; Other: Morning-only polyethylene glycol

Study type: Interventional

Funder types: Other

Identifiers

NCT01765491

11-206

Details and patient eligibility

About

Morning-only colonoscopy preparation may improve efficiency by allowing same-day patient preparation and colonoscopy. The aim of the investigators study is to compare the efficacy and tolerability of morning-only Polyethylene Glycol (PEG) to split-dose preparation in hospitalized patients undergoing colonoscopy.

Full description

This is a single-center, prospective, endoscopist-blinded study in which hospitalized patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive one gallon of PEG either the morning of colonoscopy or as a split-dose (evening-morning). The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale. The investigators pre-specified a non-inferiority margin of 1.5 for the difference in Ottawa scale between arms. Secondary end points are patient compliance and tolerance. N: 120 hospitalized patients scheduled for diagnostic colonoscopy.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients scheduled to undergo diagnostic colonoscopy during hospitalization

Exclusion criteria

• Critically ill/Intensive Care Unit patients
• Suspected bowel obstruction/perforation
• History of colon resection
• Patients with altered mental status/inability to provide informed consent
• Incarcerated patients
• Pregnant females

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Morning-only polyethylene glycol

Experimental group

Description:

One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy.

Treatment:

Other: Morning-only polyethylene glycol

Split-dose polyethylene glycol

Active Comparator group

Description:

Half gallon of polyethylene glycol to be taken between 7-9 pm on the day before colonoscopy and the remaining half between 7-9 am on the day of colonoscopy.

Treatment:

Other: Split-dose polyethylene glycol