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Completed

NCT Number: NCT01765491

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

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.

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Key information

Conditions

Bowel Preparation for Colonoscopy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Split-dose polyethylene glycol

Other

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

Morning-only polyethylene glycol

Other

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

Primary outcomes

  1. To compare the efficacy of colonoscopy preparation measured by the Ottawa scale

    Time frame: 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 outcomes

  1. Patient compliance

    Time frame: 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.

  2. Patient tolerance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cook County Health

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 10, 2013
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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