- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06794112
Optimal Bowel Preparation in Geriatric Patients With a Instructional Animation Video Before Colonoscopy
Study Overview
Status
Intervention / Treatment
Detailed Description
Colonoscopy is a critical screening method for early detection and prevention of colorectal cancer. However, the success of the procedure largely depends on the quality of bowel preparation. Inadequate bowel preparation may lead to repeated procedures, increased costs, potentially delayed diagnoses and associated poor prognosis. This problem is more prominent especially in the geriatric population over 60 years of age. With the animated video, the investigators aim to improve bowel cleansing before colonoscopy by providing visual and auditory training to participants and/or their carers. This project will both contribute to the improvement of colonoscopy preparation protocols for the geriatric population and potentially provide a model that can be adapted to other age groups.
Animation training video was created collaboratively by Mersin University Faculty of Medicine Department of General Surgery and Mersin University Graphic Arts Department.
The Boston Bowel Preparation Scale (BBPS) is a scoring system designed to assess bowel cleansing during colonoscopy. It provides a standardised, reliable measure to improve the quality and outcomes of colonoscopy procedures. While there are many different scales to measure bowel preparation, the BBPS was selected for use in the study as it is considered to be the most comprehensively validated bowel preparation scale. The BBPS is a 10-point scale that assesses bowel readiness. It assesses three segments of the colon (right, transverse and left) with scores ranging from 0 to 3 for each segment, leading to a total score of 0 to 9.
Using this scale, the investigators tried to determine whether there would be a difference in terms of bowel preparation between participants who watched an animated video and participants who were given standard instructions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hilmi Bozkurt
- Phone Number: 0905321780880
- Email: hilmibozkurt27@gmail.com
Study Contact Backup
- Name: Simge Tuna
Study Locations
-
-
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Mersin, Turkey (Türkiye), 33110
- Recruiting
- Mersin University Faculty of Medicine
-
Contact:
- Hilmi Bozkurt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 60 years of age or older
- Indication for colonoscopy
- Volunteering to participate in the study
- Preparing for colonoscopy for the first time
- No history of previous operations on the small intestine and colon
- No diagnosed bowel disease
- Language proficiency to watch the animation
- Full understanding of visual and auditory messages
Exclusion Criteria:
- Previous colonoscopy experience
- History of previous small bowel and colon surgery
- Diagnosis of inflammatory bowel disease
- Presence of toxic colon and/or megacolon
- The presence of a mass in the intestine that does not allow colonoscopy to pass
- Unwillingness to participate in the study
- Lack of language proficiency
- Lack of ability to understand visual and auditory messages
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Animation video group
Patients will receive standard written instructions and will additionally watch an animated training video
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Both arms will receive standard care (written instructions), with the experimental arm receiving an additional animated video intervention.
Standard written instructions for bowel preparation before colonoscopy
|
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Active Comparator: Written instructions only (Standard care) group
Patients will only receive standardised written instructions
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Standard written instructions for bowel preparation before colonoscopy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Bowel Preparation
Time Frame: During colonoscopy procedure
|
The primary outcome measure of this study is the quality of bowel preparation, which will be assessed using the Boston Bowel Preparation Scale (BBPS).
This validated scale will be used to evaluate the cleanliness of each colonic segment during colonoscopy.
The BBPS assigns a score of 0 to 3 for each of the three segments of the colon (right colon, transverse colon, and left colon), resulting in a total score ranging from 0 to 9. Adequate bowel preparation will be defined as a total BBPS score ≥ 6 with all segment scores ≥ 2. The assessment will be performed by endoscopists who are blinded to the patient's group allocation to minimize bias.
This standardized evaluation will provide an objective measure of the effectiveness of our video-based educational intervention compared to standard written instructions in achieving optimal bowel preparation in the geriatric population.
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During colonoscopy procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
colonoscopy completion rate
Time Frame: During colonoscopy procedure
|
This will be documented by the endoscopist during the procedure and recorded as a binary outcome
|
During colonoscopy procedure
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Simge Tuna, Mersin University
Publications and helpful links
General Publications
- Hayat U, Lee PJ, Lopez R, Vargo JJ, Rizk MK. Online Educational Video Improves Bowel Preparation and Reduces the Need for Repeat Colonoscopy Within Three Years. Am J Med. 2016 Nov;129(11):1219.e1-1219.e9. doi: 10.1016/j.amjmed.2016.06.011. Epub 2016 Jul 6.
- Ye Z, Chen J, Xuan Z, Gao M, Yang H. Educational video improves bowel preparation in patients undergoing colonoscopy: a systematic review and meta-analysis. Ann Palliat Med. 2020 May;9(3):671-680. doi: 10.21037/apm.2020.03.33. Epub 2020 Apr 13.
- Ho LH, Montealegre JR, Al-Arabi S, Jibaja-Weiss ML, Suarez MG. Impact of Colonoscopy Preparation Video on Boston Bowel Preparation Scale Score. Gastroenterol Nurs. 2019 May/Jun;42(3):251-258. doi: 10.1097/SGA.0000000000000391.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024/1269
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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