- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04728867
Comparison of Textbook Versus 3D Animation Versus Cadaveric Training Video in Teaching Laparoscopic Rectal Surgery
Comparison of Textbook Versus 3D Animation Versus Cadaveric Training Video in Teaching Laparoscopic Rectal Surgery: A Prospective Randomized Clinical Trial From Tertiary Care Center
Digital 3D animation and cadaveric videos have been increasingly used in surgical education and provide tremendous opportunity to develop new surgical educational tools, particularly during this Coronavirus-19 pandemic period.
This prospective, randomized, blinded study is designed to compare the educational effectiveness of various educational tools including the surgical textbook, animation, and cadaveric videos in laparoscopic rectal surgery among board-certificated surgeons. Initially, an electronic questionnaire assessing the knowledge about laparoscopic rectal surgery will be created and validated by the board-certificated colorectal surgeons. Exploratory and confirmatory factor analyses will be utilized to test the structure validity of the questionnaire. After the questionnaire will be sent to the graduates completing the general surgery residency program in Turkey, the volunteers will be then randomized into four groups based on the study material including a textbook, 3D animation, cadaveric video, and both 3D animation + cadaveric video. A step-by-step educational 3D animation and a cadaveric video will be prepared in order to teach the technical steps of laparoscopic rectal surgery. Volunteers in four groups were given 2 weeks to review their educational material. After the 2-weeks of the study period, the volunteers will be asked to answers the same electronic questionnaire imported in the edited live laparoscopic rectal surgery. Pre- and post-educational assessment of the questionnaire among the groups will be performed and compared.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mehmet Ayhan Kuzu, MD, PhD
- Phone Number: +09005307313770
- Email: Mehmet.Ayhan.Kuzu@ankara.edu.tr
Study Contact Backup
- Name: Cigdem Benlice
- Phone Number: +09005307313770
- Email: cigdembenlice@gmail.com
Study Locations
-
-
-
Ankara, Turkey
- Recruiting
- Ankara University
-
Contact:
- Mehmet Ayhan Kuzu, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- General surgeon who graduated at least 5 years ago from the residency
- General surgeon who is proficient to perform open rectal surgery
- General surgeon who was scrubbed in/assisted for laparoscopic rectal surgery
- General surgeon who is not able to perform laparoscopic rectal surgery by itself
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Surgical textbook
Volunteers in four groups were given 4 weeks to review their educational material at least two times.
For this group, this will be a textbook chapter explaining the details for laparoscopic rectal surgery.
|
This prospective, randomized, blinded study is designed to compare the educational effectiveness of various educational tools including the surgical textbook, animation, and cadaveric videos in laparoscopic rectal surgery among board-certificated surgeons.
|
Active Comparator: 3D animation
Volunteers in four groups were given 4 weeks to review their educational material at least two times.
For this group, this will be an educational animation video showing laparoscopic rectal surgery.
|
This prospective, randomized, blinded study is designed to compare the educational effectiveness of various educational tools including the surgical textbook, animation, and cadaveric videos in laparoscopic rectal surgery among board-certificated surgeons.
|
Active Comparator: Cadaveric video
Volunteers in four groups were given 4 weeks to review their educational material at least two times.
For this group, this will be an educational cadaveric dissection video showing laparoscopic rectal surgery.
|
This prospective, randomized, blinded study is designed to compare the educational effectiveness of various educational tools including the surgical textbook, animation, and cadaveric videos in laparoscopic rectal surgery among board-certificated surgeons.
|
Active Comparator: Both 3D animation + cadaveric video
Volunteers in four groups were given 4 weeks to review their educational material at least two times.
For this group, this will be both animation and educational cadaveric dissection video showing laparoscopic rectal surgery.
|
This prospective, randomized, blinded study is designed to compare the educational effectiveness of various educational tools including the surgical textbook, animation, and cadaveric videos in laparoscopic rectal surgery among board-certificated surgeons.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of rectal cancer assessment scores among the groups before and after the education
Time Frame: 3 months
|
Rectal cancer questionnaire that assesses the knowledge about laparoscopic rectal cancer surgery.
We are expecting to see improved post-educational scores (higher than 20- mean value) (rectal cancer educational questionnaire) compared to the pre-educational scores.
Higher than 20 is improved and better outcomes Range: 15-25
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Cigdem Benlice, Ankara University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- I3-73-19
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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