Comparison of Two Methods of Bowel Preparation for Colonoscopy in Hospitalized Patients
|ClinicalTrials.gov Identifier: NCT01765491|
Recruitment Status : Completed
First Posted : January 10, 2013
Last Update Posted : January 10, 2013
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Bowel Preparation for Colonoscopy||Other: Split-dose polyethylene glycol Other: Morning-only polyethylene glycol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Morning-only With Split-dose Polyethylene Glycol for Colonoscopy Preparation in Hospitalized Patients: A Randomized Controlled Non-Inferiority Study|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Morning-only polyethylene glycol
One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy.
Other: Morning-only polyethylene glycol
One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy
Active Comparator: 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.
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
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765491
|United States, Illinois|
|John H Stroger Jr Hospital of Cook County|
|Chicago, Illinois, United States, 60612|
|Study Director:||Bashar Attar, MD, PhD||Cook County Health and Hospitals System|