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

Not Applicable

Completed

• Conditions: Bowel Preparation for Colonoscopy
• Interventions: Other: Morning-only polyethylene glycol; Other: Split-dose polyethylene glycol

• Registration Number: NCT01765491
• Lead Sponsor: Cook County Health

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.

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-10
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morning-only polyethylene glycol	Morning-only polyethylene glycol	One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy.
Split-dose polyethylene glycol	Split-dose polyethylene glycol	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.

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of colonoscopy preparation measured by the Ottawa scale	Day of procedure	Colonoscopy 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 Outcome Measures

Name	Time	Method
Patient compliance	Day of procedure	Before the patients were taken to the endoscopy suite, they completed a questionnaire, asking the amount of preparation that was taken to evaluate compliance.
Patient tolerance	Same day	Before 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.

Trial Locations

Locations (1)

John H Stroger Jr Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States