Mastery Learning Inguinal Hernia Repair

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01085500
First received: March 10, 2010
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

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 Intervention
Inguinal Hernia
Behavioral: Mastery Learning TEP Curriculum
Procedure: Current Practice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Mastery Learning Totally Extraperitoneal Inguinal Hernia Repair: Linking Surgical Simulation to Patient Level Outcomes

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: February 2010
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simulation Curriculum
General surgery residents will undergo a simulation-based educational curriculum on TEP hernia repair
Behavioral: Mastery Learning TEP Curriculum
A simulation-based educational curriculum
Other Name: TEP Curriculum
No Intervention: Current Practice
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.

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  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085500

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David R Farley, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: David R. Farley, MD, Mayo Clinic, Rochester, MN
ClinicalTrials.gov Identifier: NCT01085500     History of Changes
Other Study ID Numbers: 09-008118, 1UL1RR024150
Study First Received: March 10, 2010
Results First Received: May 16, 2011
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
laparoscopic
totally extraperitoneal inguinal hernia repair

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on September 22, 2014