학술논문

Laparoscopic skill assessment of practicing surgeons prior to enrollment in a surgical trial of a new laparoscopic procedure
Document Type
Original Paper
Source
Surgical Endoscopy: And Other Interventional TechniquesOfficial Journal of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and European Association for Endoscopic Surgery (EAES). August 2017 31(8):3313-3319
Subject
Assessment
Laparoscopy
Clinical trial
Simulation
Melanoma
Groin dissection
Minimally invasive
Videoscopic
Inguinal
Learning curve
Language
English
ISSN
0930-2794
1432-2218
Abstract
Background: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.Methods: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.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 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).Conclusions: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.