title: Laparoscopic skill assessment of practicing surgeons prior to enrollment in a surgical trial of a new laparoscopic procedure.
abstract: Outcomes of surgical trials hinge on surgeon selection and their underlying expertise. Assessment of expertise is paramount. We investigated whether surgeons' performance measured by the fundamentals of laparoscopic surgery (FLS) assessment program could predict their performance in a surgical trial.
  
  
  
  As part of a prospective multi-institutional study of minimally invasive inguinal lymphadenectomy (MILND) for melanoma, surgical oncologists with no prior MILND experience underwent pre-trial FLS assessment. Surgeons completed MILND training, began enrolling patients, and submitted videos of each MILND case performed. Videos were scored with the global operative assessment of laparoscopic skills (GOALS) tool. Associations between baseline FLS scores and participant's trial performance metrics were assessed.
  
  
  
  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 GOALS score was 17.1 (range 9.6-21.2, max possible score 30). Inter-rater reliability was excellent (ICC = 0.85). FLS scores correlated with improved GOALS scores (r = 0.57, p = 0.05) and with decreased operative time (r = -0.6, 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).
  
  
  
  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 trial outcome measures showed no difference. Our findings have implications for the documentation of laparoscopic expertise of surgeons in practice and may allow more appropriate selection of surgeons to participate in clinical trials.
authors.affiliation: Department of Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Zendejas
authors.affiliation: Department of Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. jakub.james@mayo.edu.
authors.forename: James W
authors.initials: JW
authors.lastname: Jakub
authors.affiliation: Department of Surgery, Ohio State University Medical Center, Columbus, OH, USA.
authors.forename: Alicia M
authors.initials: AM
authors.lastname: Terando
authors.affiliation: Department of Surgery, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
authors.forename: Amod
authors.initials: A
authors.lastname: Sarnaik
authors.affiliation: Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
authors.forename: Charlotte E
authors.initials: CE
authors.lastname: Ariyan
authors.affiliation: Department of Surgical Oncology, John Wayne Cancer Institute, Santa Monica, CA, USA.
authors.forename: Mark B
authors.initials: MB
authors.lastname: Faries
authors.affiliation: Department of Surgery, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Sabino
authors.initials: S
authors.lastname: Zani
authors.affiliation: Division of General Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
authors.forename: Heather B
authors.initials: HB
authors.lastname: Neuman
authors.affiliation: Department of Surgery, Mayo Clinic, Phoenix, AZ, USA.
authors.forename: Nabil
authors.initials: N
authors.lastname: Wasif
authors.affiliation: Department of Surgery, Fox Chase Cancer Center, Philadelphia, PA, USA.
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Farma
authors.affiliation: Department of Surgery, MetroHealth Medical Center, Cleveland, OH, USA.
authors.forename: Bruce J
authors.initials: BJ
authors.lastname: Averbook
authors.affiliation: Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
authors.forename: Karl Y
authors.initials: KY
authors.lastname: Bilimoria
authors.affiliation: Department of Surgery, University of Texas Medical Branch, Galveston, TX, USA.
authors.forename: Douglas
authors.initials: D
authors.lastname: Tyler
authors.affiliation: Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.|Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
authors.forename: Mary Sue
authors.initials: MS
authors.lastname: Brady
authors.affiliation: Department of Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
authors.forename: David R
authors.initials: DR
authors.lastname: Farley
mesh_terms: D002983:Clinical Competence; D005260:Female; D006119:Groin / Q000601:surgery; D006801:Humans; D010535:Laparoscopy / Q000193:education* / Q000592:standards; D008197:Lymph Node Excision / Q000379:methods* / Q000592:standards; D008198:Lymph Nodes / Q000473:pathology; D008297:Male; D008545:Melanoma / Q000601:surgery*; D019060:Minimally Invasive Surgical Procedures / Q000193:education / Q000592:standards; D061646:Operative Time; D011183:Postoperative Complications; D015397:Program Evaluation; D011446:Prospective Studies; D015203:Reproducibility of Results
keywords: Assessment; Clinical trial; Groin dissection; Inguinal; Laparoscopy; Learning curve; Melanoma; Minimally invasive; Simulation; Videoscopic