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

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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