Mastery Learning Inguinal Hernia Repair
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|ClinicalTrials.gov Identifier: NCT01085500|
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : June 10, 2011
Last Update Posted : October 28, 2016
|First Submitted Date ICMJE||March 10, 2010|
|First Posted Date ICMJE||March 12, 2010|
|Results First Submitted Date||May 16, 2011|
|Results First Posted Date||June 10, 2011|
|Last Update Posted Date||October 28, 2016|
|Start Date ICMJE||February 2010|
|Primary Completion Date||January 2011 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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.
|Original Primary Outcome Measures ICMJE
||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.
|Change History||Complete list of historical versions of study NCT01085500 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Mastery Learning Inguinal Hernia Repair|
|Official Title ICMJE||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.
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.
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 Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
|Condition ICMJE||Inguinal Hernia|
|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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||May 2011|
|Primary Completion Date||January 2011 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
- 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.
|Ages||18 Years to 50 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01085500|
|Other Study ID Numbers ICMJE||09-008118
1UL1RR024150 ( U.S. NIH Grant/Contract )
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||David R. Farley, Mayo Clinic|
|Study Sponsor ICMJE||Mayo Clinic|
|Collaborators ICMJE||National Center for Research Resources (NCRR)|
|PRS Account||Mayo Clinic|
|Verification Date||September 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP