Benjamin Zendejas, MD, MSc1, James W Jakub, MD1, Travis E Grotz, MD1, Alicia M Terando, MD2, Amod Sarnaik, MD3, Charlotte E Ariyan, MD4, Mark B Faries, MD5, Sabino Zani Jr., MD6, Heather B Neuman, MD, MS7, Nabil Wasif, MD8, Jeffrey M Farma, MD9, Bruce J Averbook, MD10, Karl Y Bilimoria, MD, MS11, Douglas Tyler, MD12, Mary S Brady, MD4, Jeffrey D Wayne, MD11, Todd A Kellogg, MD1, David R Farley, MD1. 1Mayo Clinic – Rochester, 2Ohio State University, 3H. Lee Moffitt Cancer Center, 4Memorial Sloan Kettering Cancer Center, 5John Wayne Cancer Institute, 6Duke University, 7University of Wisconsin – Madison, 8Mayo Clinic – Arizona, 9Fox Chase Cancer Center, 10Metrohealth Medical Center, Cleveland, 11Northwestern University, 12University of Texas, Galveston
Introduction: Outcomes of surgical trials hinge on surgeon selection and their underlying expertise. How to best document surgeons' expertise prior to enrollment in a surgical trial is not known. We investigated whether surgeons' performance measured by the fundamentals of laparoscopic surgery (FLS) assessment program could predict their performance in a surgical trial.
Methods: As part of a prospective multi-institutional study of minimally invasive inguinal lymph node dissection (MILND) for melanoma, surgical oncologists experienced in open inguinal dissection, but no prior MILND experience, participated in a one-day MILND training course (didactics, video review, and cadaver training). All participants underwent pre-course assessments on the 5 FLS tasks. Subsequently, each surgeon submitted videos of each MILND case performed in the surgical trial. Videos were scored with the global operative assessment of laparoscopic skills (GOALS) tool by two independent raters. Associations between baseline FLS scores and participant’s trial performance metrics were assessed.
Results: Twelve surgeons enrolled patients; their median total baseline FLS score was 332 (range 275-380, max possible 500, passing >270). Participants enrolled 87 patients in the study (median 6 per surgeon, range 1-24), of which 72 (83%) videos were adequate for scoring. Baseline median MILND operative performance (GOALS) score was 17.1 (range 9.6-21.2, max possible score 30). Inter-rater reliability was excellent (ICC=0.85). Greater baseline FLS scores correlated with improved baseline GOALS scores (r=0.34, p=0.05) and with shorter operative times (r=-0.24, p=0.02). No associations were found with the degree of patient recruitment (r=0.02, p=0.7), lymph node count (r=0.01, p=0.07), conversion rate (r=-0.06, p=0.38) or major complications(r=-0.14, p=0.6).
Conclusion: FLS skill assessment of surgeons prior to their enrollment in a surgical trial is feasible. Although better FLS scores predicted improved operative performance and operative time, other outcome measures showed no difference by FLS performance. Our findings have implications for the recruitment and documentation of laparoscopic expertise of surgeons and potential success of surgical clinical trials.