title: The Effect of Product Safety Courses on the Adoption and Outcomes of LESS Surgery.
abstract: OBJECTIVE
  As technology in surgery evolves, the medical instrument industry is inevitability involved in promoting the use and appropriate (ie, effective and safe) application of its products. This study was undertaken to evaluate industry-supported product safety courses in laparoendoscopic single-site (LESS) surgery, by using the metrics of surgeons' adoption of the technique, safety of the procedure, and surgeons' perception of the surgery.
  
  
  METHODS
  LESS surgery courses that involved didactic lectures, operative videos, operation observation, collaborative learning, and simulation, were attended by 226 surgeons. With Florida Hospital Tampa Institutional Review Board approval, the surgeons were queried before and immediately after the course, to assess their attitudes toward LESS surgery. Then, well after the course, the surgeons were contacted, repeatedly if necessary, to complete questionnaires.
  
  
  RESULTS
  Before the course, 82% of the surgeons undertook more than 10 laparoscopic operations per month. Immediately after the course, 86% were confident that they were prepared to perform LESS surgery. Months after the course, 77% of the respondents had adopted LESS surgery, primarily cholecystectomy; 59% had added 1 or more trocars in 0-20% of their procedures; and 73% held the opinion that operating room observation was the most helpful learning experience. Complications with LESS surgery were noted 12% of the time. Advantages of the technique were better cosmesis (58%) and patient satisfaction (38%). Disadvantages included risk of complications (37%) and higher technical demand (25%). Seventy-eight percent viewed LESS surgery as an advancement in surgical technique.
  
  
  CONCLUSIONS
  In multifaceted product safety courses, operating room observation is thought to provide the most helpful instruction for those wanting to undertake LESS surgery. The procedure has been safely adopted by surgeons who frequently perform laparoscopies. The tradeoff is in performing a more difficult technique to obtain better cosmesis for the patient. We must continue to conduct critical evaluations of product safety courses for the introduction of new technology in surgery.
authors.affiliation: Florida Hospital Tampa, Tampa, Florida.
authors.forename: Paul G
authors.initials: PG
authors.lastname: Toomey
authors.affiliation: Florida Hospital Tampa, Tampa, Florida.
authors.forename: Sharona B
authors.initials: SB
authors.lastname: Ross
authors.affiliation: Florida Hospital Tampa, Tampa, Florida.
authors.forename: Edward
authors.initials: E
authors.lastname: Choung
authors.affiliation: Florida Hospital Tampa, Tampa, Florida.
authors.forename: Natalie
authors.initials: N
authors.lastname: Donn
authors.affiliation: Florida Hospital Tampa, Tampa, Florida.
authors.forename: Michelle
authors.initials: M
authors.lastname: Vice
authors.affiliation: Florida Hospital Tampa, Tampa, Florida.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Luberice
authors.affiliation: Florida Hospital Tampa, Tampa, Florida.
authors.forename: Michael
authors.initials: M
authors.lastname: Albrink
authors.affiliation: Florida Hospital Tampa, Tampa, Florida.
authors.forename: Alexander S
authors.initials: AS
authors.lastname: Rosemurgy
mesh_terms: D001291:Attitude of Health Personnel; D004502:Education, Medical, Continuing; D006801:Humans; D010535:Laparoscopy / Q000193:education* / Q000379:methods*; D012449:Safety; D066231:Surgeons
keywords: Laparoendoscopic single-site surgery; Product safety courses; Single-incision laparoscopic surgery