Mastery Learning Inguinal Hernia Repair

NCT01085500 | Completed Results

• 2 other identifiers: 09-0081181UL1RR024150
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Keywords

laparoscopic; totally extraperitoneal inguinal hernia repair

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  at first TEP procedure post-randomization, subjects were followed for the duration of hospital stay, an average of 1 night

Study Arms (2)

Simulation Curriculum

EXPERIMENTAL

General surgery residents will undergo a simulation-based educational curriculum (Mastery Learning TEP Curriculum) on TEP hernia repair

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.

Procedure: Current Practice

Interventions

Mastery Learning TEP Curriculum BEHAVIORAL

A simulation-based educational curriculum

Also known as: TEP Curriculum

Simulation Curriculum

Current Practice PROCEDURE

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.

Current Practice

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Publications (1)

• 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.

  PMID: 21865947 RESULT

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Benjamin Zendejas, MD
• Organization: Mayo Clinic

zendejas.benjamin@mayo.edu

507-538-5413

Study Officials

• David R Farley, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 12, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 28, 2016
• Results First Posted: June 10, 2011

Record last verified: 2016-09

Locations

US (1)