Inguinal HerniaNCT01085500
Mastery Learning Inguinal Hernia Repair
A study testing Mastery Learning TEP Curriculum and Current Practice in people with Inguinal Hernia, run by Mayo Clinic at 1 site in United States.
Trial summary
Abstract: Minimally invasive techniques are now ubiquitous in the management of surgical disease. Competence in laparoscopy requires specialized training and practice. With the decrease of resident work hours, training programs need to explore and adopt efficient strategies to teach and evaluate laparoscopic skills. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Mastery Learning TEP Curriculum and Current Practice
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- General surgery residents (male or female), regardless of age or previous laparoscopic experience, who are able to perform at least 2 TEP inguinal hernia repairs during the study period (January - December 2010)
- Postgraduate Year (PGY) 1 to PGY 5 general surgery residents.
- Have the procedure supervised by one of the following expert laparoscopic surgeons: Dr. David Farley, Dr. Bingener-Casey, Dr. Swain, Dr. Kendrick
Who cannot join
- PGY 1 designated preliminary residents (Urology, Orthopedics, Neurosurgery and Anesthesia) or PGY 1 non-designated preliminary residents who are applying to fields other than general surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mastery Learning Totally Extraperitoneal Inguinal Hernia Repair: Linking Surgical Simulation to Patient Level Outcomes
Abstract: Minimally invasive techniques are now ubiquitous in the management of surgical disease. Competence in laparoscopy requires specialized training and practice. With the decrease of resident work hours, training programs need to explore and adopt efficient strategies to teach and evaluate laparoscopic skills. For economic, ethical, and legal considerations, the operating room may no longer be the ideal environment for teaching these basic technical skills. There appears to be a role for simulation in response to this need. The transfer of laparoscopic skills learned in a simulated environment to the operating room has showed mixed results. Overall, it seems that surgical skills training outside the operating room is beneficial, but the best method(s) of designing, implementing and evaluating such skills curriculums have yet to be identified.
The laparoscopic totally extraperitoneal (TEP) inguinal hernia repair is an example of a procedure that is associated with a steep learning curve and requires mastery of basic laparoscopic skills. In addition, an increased recurrence and complication rates in the early learning curve of this procedure, underscores the importance of adequate training. The current practice of teaching the TEP repair in the operating room under an apprenticeship-based model is associated with increased operative time and costs. We propose that the training of surgical trainees outside the operating room with a structured, mastery oriented simulation-based curriculum will help reduce the learning curve of the TEP repair, improve operative performance, and decrease operative time and costs.
Read the detailed description
Specific Aims:
Inguinal hernias are a common ailment of the general population. Their surgical management through a laparoscopic totally extraperitoneal (TEP) approach has been shown to lead to less discomfort and faster recovery than do classic open repairs with equal effectiveness. Nonetheless, the TEP repair has not been adopted widely because of concerns regarding a substantial learning curve. In addition, the current practice of teaching the TEP procedure in the operating room under an apprenticeship-based model is associated with increased operative time and cost. The training of surgeons in laparoscopic skills outside the operating room with simulation-based strategies has emerged as an attractive alternative. Many studies have demonstrated that trainees who practice laparoscopic skills in a simulated environment show improvement of those skills when tested in that same environment. Few studies however, have been able to demonstrate a direct correlation between such simulation training and improved performance in the operating room. It appears from these studies that surgical skills training outside the operating room is beneficial, but the best methods have yet to be identified.
Our long-term research goal is to explore and adopt efficient simulation-based strategies to teach and evaluate surgical skills to surgical trainees. Our objective for this study is to design and evaluate a simulation-based curriculum based upon the concepts of mastery learning theory (achievement of pre-specified expert-derived benchmarks without time constraints) and to develop an objective mean of assessing operative performance that will both aid in shortening the learning curve of the TEP inguinal hernia repair for surgical trainees. Our central hypothesis is that the training of surgery residents outside the operative room with simulation-based strategies, such as the TEP mastery learning curriculum will improve operative performance and reduce operative time during the TEP repair. The rationale for this study is that the identification of effective strategies to shorten the learning curve of the TEP repair that translate into decreased operative time will not only increase the adoption of the TEP repair with its inherent benefits to more candidate patients, but will also lead to substantial cost-savings and perhaps improved patient outcomes. We are especially well prepared to complete this study as we are a part of an academic referral center that treats a myriad of inguinal hernias patients and educates hundreds of surgical residents on a continuous basis.
Specific Aim 1: To compare the TEP mastery learning curriculum with the apprenticeship-based model of learning the TEP repair in the operative room on operative time and operative performance of TEP inguinal hernia repairs performed by surgical trainees.
Hypothesis 1a: Surgical trainees who undergo the TEP mastery learning curriculum will achieve lesser mean operative times while performing a TEP inguinal hernia repair when compared to those who followed the apprenticeship-based model.
Hypothesis 1b: Surgical trainees who undergo the TEP mastery learning curriculum will achieve greater mean operative performance scores while performing a TEP inguinal hernia repair when compared to those who followed the apprenticeship-based model.
Secondary Aim:
Compare the rate of TEP inguinal hernia repair post-operative complications, specifically urinary retention for patients operated on by surgical residents who underwent the mastery learning curriculum versus those who underwent the apprenticeship-based model.
This research is innovative because it will challenge the current paradigm of teaching basic laparoscopic skills in the operative room and will strive to link surgical education methods to objective patient level outcomes such as operative time and cost. At the completion of this project, it is our expectation that we will be better prepared to continue our efforts of translating new educational modalities/technologies to improve the delivery of healthcare. Our anticipated findings will have a relevant impact in how we educate the surgeons of tomorrow.
- Conditions
- Inguinal Hernia
- Being tested
- Mastery Learning TEP Curriculum, Current Practice
- Keywords
- laparoscopic, totally extraperitoneal inguinal hernia repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mastery Learning TEP CurriculumBehavioural
Also called TEP Curriculum
A simulation-based educational curriculum
Current PracticeProcedure or surgery
The current practice of learning how to perform the TEP repair in the operating room is under direct supervision of the staff surgeon without any simulation pre-training.
| Study group | Role | What they receive |
|---|---|---|
| Simulation Curriculum | Experimental | General surgery residents will undergo a simulation-based educational curriculum (Mastery Learning TEP Curriculum) on TEP hernia repair Receives: Behavioral: Mastery Learning TEP Curriculum |
| Current Practice | Other | General surgery residents will undergo current practice of learning how to perform the TEP repair in the operating room under direct supervision of the staff surgeon without any simulation pre-training. Receives: Procedure: Current Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation-Corrected Operative Time
Operative time was recorded with a standard stopwatch, began at the start of the operative case and ended when procedure was terminated. We realized that the operative time for poorly performing trainees could be faster than the time for more skilled trainees because the supervising surgeon would perform a greater proportion of the procedure. We calculated participation-corrected time as raw total time + the time of staff involvement: time_corrected = time_raw + (1-participation) x time_raw.
Measured: at first TEP procedure post-randomization; Due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two
Secondary outcomes (2)
Operative Performance
The trained observer and the staff supervising surgeon graded operative performance independently using a global rating scale, Global Operative Assessment of Laparoscopic Skills (GOALS) immediately after each case, (1 rating per case if bilateral repair). The GOALS tool has been shown to be a valid and reliable tool to measure generic laparoscopic skills in the simulated environment and in the operating room, with good agreement between live and video-review ratings. The scores range from 6 to 30, a higher score indicates greater operative performance.
Measured: at first TEP procedure post-randomization; due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two
Number of Hernia Repair Subjects With Post-Operative Urinary Retention
Urinary retention is the inability to empty the bladder. This is an educational study for surgeons. The participants in the study are surgeons, and the participant flow, baseline characteristics and first two outcome measures are for the surgeons. During the part of the study reported for the third outcome measure, the first surgical procedure (TEP) after randomization, each surgeon had one subject. Therefore, this outcome measure is for the hernia patients or subjects.
Measured: at first TEP procedure post-randomization, subjects were followed for the duration of hospital stay, an average of 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, David R. Farley, Mayo Clinic
- Investigators
- David R Farley, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085500
- Sponsor's protocol ID
- 09-008118
- Other IDs
- 1UL1RR024150
- Status last verified
- Sep 2016
- First submitted
- 10 Mar 2010
- Last updated
- 28 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zendejas B, Cook DA, Bingener J, Huebner M, Dunn WF, Sarr MG, Farley DR. Simulation-based mastery learning improves patient outcomes in laparoscopic inguinal hernia repair: a randomized controlled trial. Ann Surg. 2011 Sep;254(3):502-9; discussion 509-11. doi: 10.1097/SLA.0b013e31822c6994.
PubMed 21865947
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastery Learning Totally Extraperitoneal Inguinal Hernia Repair: Linking Surgical Simulation to Patient Level Outcomes
- ClinicalTrials.gov ID
- NCT01085500
- Acronym / sponsor ID
- 09-008118
- Conditions
- Inguinal Hernia
- Keywords
- laparoscopic, totally extraperitoneal inguinal hernia repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Feb 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Posted 10 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Abstract: Minimally invasive techniques are now ubiquitous in the management of surgical disease. Competence in laparoscopy requires specialized training and practice. With the decrease of resident work hours, training programs need to explore and adopt efficient strategies to teach and evaluate laparoscopic skills. For economic, ethical, and legal considerations, the operating room may no longer be the ideal environment for teaching these basic technical skills. There appears to be a role for simulation in response to this need. The transfer of laparoscopic skills learned in a simulated environment to the operating room has showed mixed results. Overall, it seems that surgical skills training outside the operating room is beneficial, but the best method(s) of designing, implementing and evaluating such skills curriculums have yet to be identified.
The laparoscopic totally extraperitoneal (TEP) inguinal hernia repair is an example of a procedure that is associated with a steep learning curve and requires mastery of basic laparoscopic skills. In addition, an increased recurrence and complication rates in the early learning curve of this procedure, underscores the importance of adequate training. The current practice of teaching the TEP repair in the operating room under an apprenticeship-based model is associated with increased operative time and costs. We propose that the training of surgical trainees outside the operating room with a structured, mastery oriented simulation-based curriculum will help reduce the learning curve of the TEP repair, improve operative performance, and decrease operative time and costs.
Detailed description
Specific Aims:
Inguinal hernias are a common ailment of the general population. Their surgical management through a laparoscopic totally extraperitoneal (TEP) approach has been shown to lead to less discomfort and faster recovery than do classic open repairs with equal effectiveness. Nonetheless, the TEP repair has not been adopted widely because of concerns regarding a substantial learning curve. In addition, the current practice of teaching the TEP procedure in the operating room under an apprenticeship-based model is associated with increased operative time and cost. The training of surgeons in laparoscopic skills outside the operating room with simulation-based strategies has emerged as an attractive alternative. Many studies have demonstrated that trainees who practice laparoscopic skills in a simulated environment show improvement of those skills when tested in that same environment. Few studies however, have been able to demonstrate a direct correlation between such simulation training and improved performance in the operating room. It appears from these studies that surgical skills training outside the operating room is beneficial, but the best methods have yet to be identified.
Our long-term research goal is to explore and adopt efficient simulation-based strategies to teach and evaluate surgical skills to surgical trainees. Our objective for this study is to design and evaluate a simulation-based curriculum based upon the concepts of mastery learning theory (achievement of pre-specified expert-derived benchmarks without time constraints) and to develop an objective mean of assessing operative performance that will both aid in shortening the learning curve of the TEP inguinal hernia repair for surgical trainees. Our central hypothesis is that the training of surgery residents outside the operative room with simulation-based strategies, such as the TEP mastery learning curriculum will improve operative performance and reduce operative time during the TEP repair. The rationale for this study is that the identification of effective strategies to shorten the learning curve of the TEP repair that translate into decreased operative time will not only increase the adoption of the TEP repair with its inherent benefits to more candidate patients, but will also lead to substantial cost-savings and perhaps improved patient outcomes. We are especially well prepared to complete this study as we are a part of an academic referral center that treats a myriad of inguinal hernias patients and educates hundreds of surgical residents on a continuous basis.
Specific Aim 1: To compare the TEP mastery learning curriculum with the apprenticeship-based model of learning the TEP repair in the operative room on operative time and operative performance of TEP inguinal hernia repairs performed by surgical trainees.
Hypothesis 1a: Surgical trainees who undergo the TEP mastery learning curriculum will achieve lesser mean operative times while performing a TEP inguinal hernia repair when compared to those who followed the apprenticeship-based model.
Hypothesis 1b: Surgical trainees who undergo the TEP mastery learning curriculum will achieve greater mean operative performance scores while performing a TEP inguinal hernia repair when compared to those who followed the apprenticeship-based model.
Secondary Aim:
Compare the rate of TEP inguinal hernia repair post-operative complications, specifically urinary retention for patients operated on by surgical residents who underwent the mastery learning curriculum versus those who underwent the apprenticeship-based model.
This research is innovative because it will challenge the current paradigm of teaching basic laparoscopic skills in the operative room and will strive to link surgical education methods to objective patient level outcomes such as operative time and cost. At the completion of this project, it is our expectation that we will be better prepared to continue our efforts of translating new educational modalities/technologies to improve the delivery of healthcare. Our anticipated findings will have a relevant impact in how we educate the surgeons of tomorrow.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation Curriculum | Experimental | Behavioral: Mastery Learning TEP CurriculumGeneral surgery residents will undergo a simulation-based educational curriculum (Mastery Learning TEP Curriculum) on TEP hernia repair |
| Current Practice | Other | Procedure: Current PracticeGeneral surgery residents will undergo current practice of learning how to perform the TEP repair in the operating room under direct supervision of the staff surgeon without any simulation pre-training. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- General surgery residents (male or female), regardless of age or previous laparoscopic experience, who are able to perform at least 2 TEP inguinal hernia repairs during the study period (January - December 2010)
- Postgraduate Year (PGY) 1 to PGY 5 general surgery residents.
- Have the procedure supervised by one of the following expert laparoscopic surgeons: Dr. David Farley, Dr. Bingener-Casey, Dr. Swain, Dr. Kendrick
Key exclusion criteria (1 listed)
- PGY 1 designated preliminary residents (Urology, Orthopedics, Neurosurgery and Anesthesia) or PGY 1 non-designated preliminary residents who are applying to fields other than general surgery.
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 |
|---|---|---|
| Mastery Learning TEP CurriculumAlso: TEP CurriculumA simulation-based educational curriculum | Behavioural | Simulation Curriculum |
| Current PracticeThe current practice of learning how to perform the TEP repair in the operating room is under direct supervision of the staff surgeon without any simulation pre-training. | Procedure or surgery | Current Practice |
Primary outcome
Participation-Corrected Operative Time
Time frame: at first TEP procedure post-randomization; Due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two
Operative time was recorded with a standard stopwatch, began at the start of the operative case and ended when procedure was terminated. We realized that the operative time for poorly performing trainees could be faster than the time for more skilled trainees because the supervising surgeon would perform a greater proportion of the procedure. We calculated participation-corrected time as raw total time + the time of staff involvement: time_corrected = time_raw + (1-participation) x time_raw.
2 secondary outcomes
Operative Performance
Time frame: at first TEP procedure post-randomization; due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two
Number of Hernia Repair Subjects With Post-Operative Urinary Retention
Time frame: at first TEP procedure post-randomization, subjects were followed for the duration of hospital stay, an average of 1 night
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21865947Zendejas B, Cook DA, Bingener J, Huebner M, Dunn WF, Sarr MG, Farley DR. Simulation-based mastery learning improves patient outcomes in laparoscopic inguinal hernia repair: a randomized controlled trial. Ann Surg. 2011 Sep;254(3):502-9; discussion 509-11. doi: 10.1097/SLA.0b013e31822c6994.
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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.
David R Farley, MD 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 Mastery Learning TEP Curriculum and Current Practice in people with Inguinal 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 3 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: finished, as of the sponsor's last update on 28 Oct 2016. 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?
Yes. Results are posted in the registry (first posted 10 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participation-Corrected Operative Time (time frame: at first TEP procedure post-randomization; Due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01085500, which also lists 1 linked publication.
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 28 Oct 2016.