Comparison of Textbook Versus 3D Animation Versus Cadaveric Training Video in Teaching Laparoscopic Rectal Surgery

February 20, 2021 updated by: Mehmet Ayhan Kuzu, Ankara University

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

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Ankara, Turkey
        • Recruiting
        • Ankara University
        • Contact:
          • Mehmet Ayhan Kuzu, MD, PhD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Cigdem Benlice, Ankara University

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 (Actual)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

January 24, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 20, 2021

Last Verified

February 1, 2021

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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