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Gainesville, Florida 32610


Purpose:

A large body of evidence suggests that a well-structured curriculum, which incorporates simulated laparoscopic surgical training, improves performance in both the animate and human operating rooms. The majority of these studies have evaluated commercially available laparoscopic simulators, but very few have assessed subjects trained on a virtual-reality trainer as compared with those trained with a traditional box trainer over a specified time period. The investigator proposes to determine if training with a laparoscopic computer simulator versus collapsible box trainers leads to improved performance of laparoscopic skills in the operating room environment during a 12 months interval.


Study summary:

The exponential growth of minimally invasive surgery has challenged conventional systems for surgical training and establishment of competency. The longstanding dogma of "see one, do one, teach one," is being increasingly challenged by legal and ethical concerns for patient safety issues, malpractice concerns, operating room efficiency and surgeon efficiency. Perhaps most importantly, it is further hampered by work-hour restrictions that limit resident availability for educational endeavors. The rapid explosion of minimally invasive surgical techniques being applied to ever more complex operations additionally compounds this issue. Hence, a conundrum of how best to teach technical skills to our residents complexes and challenges the current surgical training system. A large body of evidence suggests that a well-structured curriculum, which incorporates simulated laparoscopic surgical training, improves performance in both the animate and human operating rooms. The majority of these studies have evaluated commercially available laparoscopic simulators, but very few have assessed subjects trained on a virtual-reality trainer as compared with those trained with a traditional box trainer over a specified time period. I propose to determine if training with a laparoscopic computer simulator versus collapsible box trainers leads to improved performance of laparoscopic skills in the operating room environment during a 12 months interval. I aim to accomplish this with a prospective, randomized, blinded, controlled, trial that will enroll our surgical residents to a scheduled training session in a laparoscopic computer simulator laboratory or to a control group of laparoscopic collapsible box training group. Training sessions in the two groups will cover similar skills with the same mandatory number of training repetitions. Subjects randomized will be trained and assessed on appropriate laparoscopic camera skills, instrument handling, object positioning, dissection, ligation, suturing, and knot tying at times 0, 3, 6 and every 12 months from the start of the study. All subjects will complete the same series of laparoscopic exercises in a live porcine model, and two blinded expert reviewers will assess their performance independently at each specified time interval. The porcine model is chosen as it closely recapitulates the human operating room environment and allows utilization of the same laparoscopic instrumentation and equipment used in our hospital, thereby creating a very realistic intraoperative environment. I plan to illustrate that a well-structured, timed curriculum that incorporates simulated laparoscopic surgical training that is easily accessible to the trainee will improve surgical performance and resident education. Additionally, I hope to demonstrate that on-going routine practice with the collapsible laparoscopic trainers leads to better performance and surgical outcome. Lastly, I aim to decipher if a laparoscopic computer simulator or usage of a collapsible box trainer leads to better intraoperative laparoscopic skills and a better module for resident education.


Criteria:

Inclusion Criteria: - All first and second year general surgery residents Exclusion Criteria: - anyone not a first or second year general surgery residents.


NCT ID:

NCT01191047


Primary Contact:

Principal Investigator
Kfir Ben-David, MD
University of Florida


Backup Contact:

N/A


Location Contact:

Gainesville, Florida 32610
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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