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Sroka G , Feldman LS, Vassiliou MC, Kaneva P, Fayez R, Fried GM Steinberg- Bernstein Centre for Minimally Invasive Surg

FLS Simulator Training to Proficiency Improves Laparoscopic Performance in the Operating Room – a Randomized Controlled Trial. Sroka G , Feldman LS, Vassiliou MC, Kaneva P, Fayez R, Fried GM Steinberg- Bernstein Centre for Minimally Invasive Surgery & Innovation

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Sroka G , Feldman LS, Vassiliou MC, Kaneva P, Fayez R, Fried GM Steinberg- Bernstein Centre for Minimally Invasive Surg

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  1. FLS Simulator Training to Proficiency Improves Laparoscopic Performance in the Operating Room – a Randomized Controlled Trial Sroka G, Feldman LS, Vassiliou MC, Kaneva P, Fayez R, Fried GM Steinberg- Bernstein Centre for Minimally Invasive Surgery & Innovation McGill University, Montreal, Canada

  2. Disclosure • This study was funded by an educational grant from the Royal College of Physicians and Surgeons of Canada and an unrestricted educational grant from Covidien Canada. • Dr Sroka received fellowship funding from Covidien Canada and the American Physician Fellowship.

  3. Background • Teaching laparoscopy in the OR is inefficient and frustrating for the student and the teacher. • There is growing interest in the use of simulation for surgical skills training. • No consensus regarding: • type of simulator/ tasks • method of training • skills transferability

  4. Previous Work There is evidence for transferability of skills acquired in the simulator to OR performance in laparoscopic cholecystectomy. A Systematic Review of Skills Transfer After Surgical Simulation Training. Sturm LP et al. Ann Surg 248;2.Aug 2008 Limitations of previous work: • Simulator Tasks - not validated or modified • OR Performance - Large variations in assessment methods: • not validated • not specific for Laparoscopy.

  5. Objectives • To assess whether training to a proficiency level on the FLS simulator improves operating room laparoscopic performance in junior surgical residents.

  6. Study Design • Junior Surgical Residents (PGY 1-3) • Baseline Evaluations: • Simulator Performance (FLS) • OR Performance (GOALS) • Randomization (1:1) to Training or Control • Final Evaluations: • Simulator Performance (FLS) • OR Performance (GOALS)

  7. The 5 FLS Tasks Proving the Value of Simulation in Laparoscopic Surgery GM Fried, LS Feldman et al, Annals of Surgery 240 (3) 2004.

  8. Assessment of OR Performance - GOALS • Dissection of Gallbladder from liver bed. • Scoring: 1 (worst) to 5 (best) for each domain, Max score 25 • Valid, reliable, generalizable A global assessment tool for evaluation of intraoperative laparoscopic skills M Vassiliou, Feldman LS et al;The American Journal of Surgery 190 (2005)

  9. G O A L S S c o r e FLS Score 2 5 ( G B D i s s e c t i o n f r o m l i v e r b e d ) 100 2 0 80 1 5 60 1 0 40 5 20 0 0 PGY 1-2 PGY 3-4 PGY 5+ P G Y 1 - 2 P G Y 3 - 4 P G Y 5 + Measuring performance Simulator Operating Room From: Database (76 residents); Mean (95%CI); p<0.001

  10. Simulator Training • Design of a Proficiency-Based Skills Training Curriculum for the Fundamentals of Laparoscopic Surgery EM Ritter & DJ Scott . Surgical Innovation / Vol. 14, No. 2, June 2007

  11. Sample size calculation • Outcome Measure - GOALS Score • Meaningful Difference of 5 (SD = 3) in GOALS (between junior & intermediate) • Power - 80% ; =0.05 • N=7 per group

  12. Junior Residents N=19 Baseline Evaluations: Simulator - FLS OR - GOALS 2 excluded GOALS > 15 N=17, Randomization 1:1 Training Group Control Group N=9 N=8 Regular Residency + Regular Residency FLS Simulator Proficiency Training alone Based Trai ning 1 lost to follow up Final Evaluations: N=16 Simulator - FLS OR - GOALS Results: Flow of participants through the study

  13. Simulator Training N=8 No Simulator Training N=8 P value PGY 1 / 2 / 3 5 / 2 / 1 6 / 2 / 0 0.58 Age 27 (26.5-28.5) 27 (27-28) 0.85 Gender (M/F) 6 / 2 3 / 5 0.13 Time between evaluations (days) 162 (100-256) 113 (40-167) 0.13 GB Primary 4.5 (3-7) 3.5 (2-5) 0.21 GB Assistant 4.5 (3.5-8) 4.5 (4-6) 0.92 Other Lap 2.5 (1-3.5) 2.5 (2-3.5) 0.75 Group Characteristics Median (IQR)

  14. FLS Score 120 100 95.1 80 60.5 60 49.1 40 39.5 20 Training Non Training 0 Baseline Final Results - Simulator p<0.0001 p=0.004 p=0.002 mean±SD; Student’s t test

  15. GOALS Score 25 20 17.4 15 13.8 12.0 10 11.3 5 Training Non Training 0 Baseline Final Results - OR Performance p=0.0001 p=0.0005 p=0.04 mean±SD; Student’s t test

  16. GOALS difference 8 7 6.1 6 5 4 3 1.8 2 1 0 -1 Control Training Improvement in OR Performance p=0.0003 mean±SD; Student’s t test

  17. In summary • Residents who trained to proficiency on the FLS simulator improved their OR performance significantly more than controls • The magnitude of the improvement - from a junior to intermediate level resident (2 years!) • Achieved by only 7.5 hours of Simulator Training (1/3 supervised)

  18. Conclusions • The results demonstrate skill transfer from simulator to OR. • FLS is an extremely efficient way to acquire technical skills for junior residents • FLS should become part of the curriculum.

  19. Thank you!

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