- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01911026
The Impact of Nurse Education on the Quality of Inpatient Bowel Preparation for Colonoscopy
December 25, 2014 updated by: Kim Eun Soo, Keimyung University Dongsan Medical Center
The Impact of Nurse Education on the Quality of Inpatient Bowel Preparation for Colonoscopy; Randomized Single Blinded Study
Effective bowel preparation is important for examination of the entire colon adequately and for identifying colonic lesions during colonoscopy.
However, it is well known that bowel preparation of inpatients is much poorer than that of outpatients.
Our goal is to improve bowel preparations with reinforcement of nurse education that explains the steps required for bowel preparation for inpatients undergoing colonoscopies.
The education will focus on explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the pre-colonoscopy diet, and the instructions for completing the laxative.
Patients in the control group will receive the standard written bowel preparation instructions, while patients in the intervention group will receive standard written instructions plus a explanation from reinforcement-educated nurse.
The investigators hypothesize that patients received a explanation from reinforcement-educated nurses will lead to improved patient compliance and a better bowel preparation.
In addition, the investigators hypothesize that a better quality bowel preparation will improve detection of colonic polyps and patients' satisfaction for colonoscopy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
205
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Daegu, Korea, Republic of, 700-712
- Eun Soo Kim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- all inpatients
- age >18
- referred and scheduled for an elective screening colonoscopy
Exclusion Criteria:
- outpatients
- pregnancy
- breast feeding
- prior history of surgical large bowel resection
- patients allergic to PEG-ELS based laxatives
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional
The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus interventional instructions from reinforcement educated nurse such as 'Reinforcement Nurse Education'
|
The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus instructions from reinforcement educated nurse
|
No Intervention: Standard preparation instructions
The control arm will receive written instructions on preparing for a colonoscopy per standard of care at Keimyung University Dongsan Medical Center
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of bowel preparation
Time Frame: day 1
|
The primary outcome will be the endoscopist's assessment of the quality of preparation using Boston and Ottawa bowel preparation scale
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient compliance
Time Frame: baseline
|
Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire
|
baseline
|
Colonoscope insertion and withdrawal times
Time Frame: day 1
|
Time from insertion to cecum and time from cecum to anus
|
day 1
|
Patient's willingness to do bowel preparation next time
Time Frame: baseline
|
Patient's willingness to do bowel preparation next time self-reported on a pre-procedure questionnaire
|
baseline
|
Preparation associated side effects
Time Frame: baseline
|
Presence and severity of preparation associated side effects including: bloating, abdominal pain, and nausea/vomiting
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eun Soo Kim, Professor, Keimyung University Dongsan Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
July 22, 2013
First Submitted That Met QC Criteria
July 26, 2013
First Posted (Estimate)
July 30, 2013
Study Record Updates
Last Update Posted (Estimate)
December 30, 2014
Last Update Submitted That Met QC Criteria
December 25, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2013-05-049-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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