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

Comparison of Morning-only With Split-dose Polyethylene Glycol for Colonoscopy Preparation in Hospitalized Patients: A Randomized Controlled Non-Inferiority Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01765491
Enrollment
120
Registered
2013-01-10
Start date
2012-08-31
Completion date
2012-12-31
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Preparation for Colonoscopy

Keywords

colonoscopy, bowel preparation, polyethylene glycol

Brief summary

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.

Detailed 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.

Interventions

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

OTHERMorning-only polyethylene glycol

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

Sponsors

Cook County Health
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To compare the efficacy of colonoscopy preparation measured by the Ottawa scaleDay of procedureColonoscopy was performed by gastroenterology fellows under the supervision of attending physicians and both were blinded to the type of preparation taken by the study patients. Bowel cleansing was evaluated by the Ottawa scale. Scoring of each part of the colon (right, middle and left) was done separately and the total amount of fluid was noted. The scores were then added to calculate the total score out of 14.

Secondary

MeasureTime frameDescription
Patient complianceDay of procedureBefore the patients were taken to the endoscopy suite, they completed a questionnaire, asking the amount of preparation that was taken to evaluate compliance.
Patient toleranceSame dayBefore the patients were taken to the endoscopy suite, they completed a questionnaire to evaluate tolerance for taking the preparation. Patients were asked about side-effects like nausea, vomiting, abdominal pain and bloating.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026