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

C

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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