Clinical trial NCT01085500: Mastery Learning Inguinal Hernia Repair
Official title: Mastery Learning Totally Extraperitoneal Inguinal Hernia Repair: Linking Surgical Simulation to Patient Level Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: laparoscopic
totally extraperitoneal inguinal hernia repair
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2010-03-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- 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.

Primary outcomes:
measure: Participation-Corrected Operative Time
timeFrame: 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:
measure: Operative Performance
timeFrame: 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
measure: Number of Hernia Repair Subjects With Post-Operative Urinary Retention
timeFrame: at first TEP procedure post-randomization, subjects were followed for the duration of hospital stay, an average of 1 night
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David R Farley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.