HerniaNCT01629485
Part vs Whole Task Mastery Training for Laparoscopic Hernia Repair
A study testing Online Video Curriculum, Whole Task Mastery Training and Part Task Mastery Training in people with Hernia, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators will perform a randomized controlled trial with a stratified-block design to compare the effect of the part versus whole task simulation training for TEP repairs. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hernia
- What is being tested?
- Online Video Curriculum, Whole Task Mastery Training and Part Task Mastery Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2012
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study Participants: Only residents who have achieved mastery of the TEP training curriculum (in either arm) will be eligible for OR assessment
- Patients: All patients deemed fit by the staff supervising surgeon to undergo a TEP repair will be considered for this study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Part vs Whole Task Mastery Simulation Training for Laparoscopic Hernia Repair: A Randomized Trial
The investigators will perform a randomized controlled trial with a stratified-block design to compare the effect of the part versus whole task simulation training for TEP repairs.
- Conditions
- Hernia
- Being tested
- Online Video Curriculum, Whole Task Mastery Training, Part Task Mastery Training
- Keywords
- Mastery Learning, Surgical Education, Laparoscopic Hernia Repair, Part vs Whole Task, Contextual Interference, laparoscopy, training, curriculum
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Video CurriculumBehavioural
A video curriculum has been designed for the purpose of educating general surgery residents in laparoscopic hernia repairs. The curriculum covers topics from basic anatomy, selection of patients, management, and operative technique.
Whole Task Mastery TrainingBehavioural
Trainees will undergo whole task mastery training in the TEP simulator. The benchmarks for mastery training in the setting of whole task tep repairs was established with performance measures of multiple staff surgeons previously.
Part Task Mastery TrainingBehavioural
Trainees will undergo part task mastery training in the TEP simulator. The benchmarks for mastery training in the setting of part task tep repairs was established with performance measures of multiple staff surgeons previously.
| Study group | Role | What they receive |
|---|---|---|
| Whole Task | Experimental | Trainees will undergo whole task mastery training in the TEP simulator after completing the video curriculum portion. Receives: Behavioral: Online Video Curriculum; Behavioral: Whole Task Mastery Training |
| Part Task | Experimental | Trainees will undergo a random part task mastery training in the TEP simulator after completing the video portion of the curriculum. Receives: Behavioral: Online Video Curriculum; Behavioral: Part Task Mastery Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Operative Time will be measured with a chronometer. Staff take overs and down time will be excluded from the trainee's time. Trainee time will be defined as when he/she has the instruments in his/her hands and is actively doing the case.
Measured: Measured in Seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David R. Farley, Mayo Clinic
- Investigators
- Roberto Hernandez-Irizarry, BS, Principal investigator, Mayo ClinicDavid Farley, MD, Principal investigator, Mayo ClinicBenjamin Zendejas, MD/MsC, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629485
- Sponsor's protocol ID
- 11-005712
- Status last verified
- Apr 2013
- First submitted
- 25 Jun 2012
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Part vs Whole Task Mastery Simulation Training for Laparoscopic Hernia Repair: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01629485
- Acronym / sponsor ID
- 11-005712
- Conditions
- Hernia
- Keywords
- Mastery Learning, Surgical Education, Laparoscopic Hernia Repair, Part vs Whole Task, Contextual Interference, laparoscopy, training, curriculum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 27 Jun 2012 (estimated)
- 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.
The investigators will perform a randomized controlled trial with a stratified-block design to compare the effect of the part versus whole task simulation training for TEP repairs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Task | Experimental | Behavioral: Online Video Curriculum, Behavioral: Whole Task Mastery TrainingTrainees will undergo whole task mastery training in the TEP simulator after completing the video curriculum portion. |
| Part Task | Experimental | Behavioral: Online Video Curriculum, Behavioral: Part Task Mastery TrainingTrainees will undergo a random part task mastery training in the TEP simulator after completing the video portion of the curriculum. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Study Participants: Only residents who have achieved mastery of the TEP training curriculum (in either arm) will be eligible for OR assessment
- Patients: All patients deemed fit by the staff supervising surgeon to undergo a TEP repair will be considered for this study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Online Video CurriculumA video curriculum has been designed for the purpose of educating general surgery residents in laparoscopic hernia repairs. The curriculum covers topics from basic anatomy, selection of patients, management, and operative technique. | Behavioural | Part Task, Whole Task |
| Whole Task Mastery TrainingTrainees will undergo whole task mastery training in the TEP simulator. The benchmarks for mastery training in the setting of whole task tep repairs was established with performance measures of multiple staff surgeons previously. | Behavioural | Whole Task |
| Part Task Mastery TrainingTrainees will undergo part task mastery training in the TEP simulator. The benchmarks for mastery training in the setting of part task tep repairs was established with performance measures of multiple staff surgeons previously. | Behavioural | Part Task |
Primary outcome
Operative Time
Time frame: Measured in Seconds
Operative Time will be measured with a chronometer. Staff take overs and down time will be excluded from the trainee's time. Trainee time will be defined as when he/she has the instruments in his/her hands and is actively doing the case.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
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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.
Roberto Hernandez-Irizarry, BS principal investigator
Mayo Clinic
David Farley, MD principal investigator
Mayo Clinic
Benjamin Zendejas, MD/MsC principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Video Curriculum, Whole Task Mastery Training and Part Task Mastery Training in people with Hernia, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 1 May 2013. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative Time (time frame: Measured in Seconds). 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 1 May 2013; AzTrials last refreshed its copy on 31 Oct 2026.