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

Bowel Preparation for Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765491
• Other study ID #: 11-206
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2023
• Source: Cook County Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Preparation for Colonoscopy

Intervention

Other:
• 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
• Morning-only polyethylene glycol
One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy

Locations

Country	Name	City	State
United States	John H Stroger Jr Hospital of Cook County	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Cook County Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the efficacy of colonoscopy preparation measured by the Ottawa scale	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.	Day of procedure
Secondary	Patient compliance	Before the patients were taken to the endoscopy suite, they completed a questionnaire, asking the amount of preparation that was taken to evaluate compliance.	Day of procedure
Secondary	Patient tolerance	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.	Same day