NCT04728867

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 18, 2021

Last Update Submit

February 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Surgical textbook

ACTIVE COMPARATOR

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.

Other: to compare the educational effectiveness of various educational tools

3D animation

ACTIVE COMPARATOR

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.

Other: to compare the educational effectiveness of various educational tools

Cadaveric video

ACTIVE COMPARATOR

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.

Other: to compare the educational effectiveness of various educational tools

Both 3D animation + cadaveric video

ACTIVE COMPARATOR

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.

Other: to compare the educational effectiveness of various educational tools

Interventions

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.

3D animationBoth 3D animation + cadaveric videoCadaveric videoSurgical textbook

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, Turkey (Türkiye)

RECRUITING

Study Officials

  • Cigdem Benlice

    Ankara University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: prospective, randomized, blinded study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 18, 2021

First Posted

January 28, 2021

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

February 23, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations