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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04728867
Other study ID # I3-73-19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date June 1, 2021

Study information

Verified date February 2021
Source Ankara University
Contact Mehmet Ayhan Kuzu, MD, PhD
Phone +09005307313770
Email Mehmet.Ayhan.Kuzu@ankara.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
to compare the educational effectiveness of various educational tools
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.

Locations

Country Name City State
Turkey Ankara University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of rectal cancer assessment scores among the groups before and after the education 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
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