Educational ProblemsNCT04728867
Comparison of Textbook Versus 3D Animation Versus Cadaveric Training Video in Teaching Laparoscopic Rectal Surgery
A study testing to compare the educational effectiveness of various educational tools in people with Educational Problems, run by Ankara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Educational Problems
- What is being tested?
- to compare the educational effectiveness of various educational tools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University
Ankara
Mehmet Ayhan Kuzu, MD, PhD
About this study
Official title: 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.
- Conditions
- Educational Problems
- Being tested
- to compare the educational effectiveness of various educational tools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
to compare the educational effectiveness of various educational toolsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: to compare the educational effectiveness of various educational tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Jun 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- prospective, randomized, blinded study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ayhan Kuzu, Ankara University
- Investigators
- Cigdem Benlice, Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728867
- Sponsor's protocol ID
- I3-73-19
- Status last verified
- Feb 2021
- First submitted
- 18 Jan 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Textbook Versus 3D Animation Versus Cadaveric Training Video in Teaching Laparoscopic Rectal Surgery: A Prospective Randomized Clinical Trial From Tertiary Care Center
- ClinicalTrials.gov ID
- NCT04728867
- Acronym / sponsor ID
- I3-73-19
- Conditions
- Educational Problems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- prospective, randomized, blinded study
| Arm | Type | Receives |
|---|---|---|
| Surgical textbook | Active comparator | Other: to compare the educational effectiveness of various educational toolsVolunteers 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. |
| 3D animation | Active comparator | Other: to compare the educational effectiveness of various educational toolsVolunteers 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. |
| Cadaveric video | Active comparator | Other: to compare the educational effectiveness of various educational toolsVolunteers 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. |
| Both 3D animation + cadaveric video | Active comparator | Other: to compare the educational effectiveness of various educational toolsVolunteers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| to compare the educational effectiveness of various educational toolsThis 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. | Other | 3D animation, Both 3D animation + cadaveric video, Cadaveric video, Surgical textbook |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cigdem Benlice study director
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing to compare the educational effectiveness of various educational tools in people with Educational Problems, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Ayhan Kuzu, MD, PhD (+09005307313770, Mehmet.Ayhan.Kuzu@ankara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of rectal cancer assessment scores among the groups before and after the education (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.