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
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.
|Condition or disease||Intervention/treatment||Phase|
|Inguinal Hernia||Behavioral: Mastery Learning TEP Curriculum Procedure: Current Practice||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Mastery Learning Totally Extraperitoneal Inguinal Hernia Repair: Linking Surgical Simulation to Patient Level Outcomes|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||May 2011|
Experimental: Simulation Curriculum
General surgery residents will undergo a simulation-based educational curriculum (Mastery Learning TEP Curriculum) on TEP hernia repair
Behavioral: Mastery Learning TEP Curriculum
A simulation-based educational curriculum
Other Name: TEP Curriculum
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.
Procedure: Current Practice
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.
- 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.
- 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 ]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.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085500
|United States, Minnesota|
|Rochester, Minnesota, United States, 55902|
|Principal Investigator:||David R Farley, MD||Mayo Clinic|