Laparoscopic skill assessment of practicing surgeons prior to enrollment in a surgical trial of a new laparoscopic procedure

Benjamin Zendejas, James W Jakub, Alicia M. Terando, Amod Sarnaik, Charlotte E. Ariyan, Mark B. Faries, Sabino Zani, Heather B. Neuman, Nabil Wasif, Jeffrey M. Farma, Bruce J. Averbook, Karl Y. Bilimoria, Douglas Tyler, Mary Sue Brady, David R. Farley

Research output: Contribution to journalArticle

5 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1-7
Number of pages7
JournalSurgical Endoscopy and Other Interventional Techniques
DOIs
StateAccepted/In press - Dec 7 2016

Fingerprint

Laparoscopy
Operative Time
Surgeons
Groin
Lymph Node Excision
Documentation
Patient Selection
Melanoma
Lymph Nodes
Outcome Assessment (Health Care)
Clinical Trials

Keywords

  • Assessment
  • Clinical trial
  • Groin dissection
  • Inguinal
  • Laparoscopy
  • Learning curve
  • Melanoma
  • Minimally invasive
  • Simulation
  • Videoscopic

ASJC Scopus subject areas

  • Surgery

Cite this

Laparoscopic skill assessment of practicing surgeons prior to enrollment in a surgical trial of a new laparoscopic procedure. / Zendejas, Benjamin; Jakub, James W; Terando, Alicia M.; Sarnaik, Amod; Ariyan, Charlotte E.; Faries, Mark B.; Zani, Sabino; Neuman, Heather B.; Wasif, Nabil; Farma, Jeffrey M.; Averbook, Bruce J.; Bilimoria, Karl Y.; Tyler, Douglas; Brady, Mary Sue; Farley, David R.

In: Surgical Endoscopy and Other Interventional Techniques, 07.12.2016, p. 1-7.

Research output: Contribution to journalArticle

Zendejas, B, Jakub, JW, Terando, AM, Sarnaik, A, Ariyan, CE, Faries, MB, Zani, S, Neuman, HB, Wasif, N, Farma, JM, Averbook, BJ, Bilimoria, KY, Tyler, D, Brady, MS & Farley, DR 2016, 'Laparoscopic skill assessment of practicing surgeons prior to enrollment in a surgical trial of a new laparoscopic procedure', Surgical Endoscopy and Other Interventional Techniques, pp. 1-7. https://doi.org/10.1007/s00464-016-5364-1
Zendejas, Benjamin ; Jakub, James W ; Terando, Alicia M. ; Sarnaik, Amod ; Ariyan, Charlotte E. ; Faries, Mark B. ; Zani, Sabino ; Neuman, Heather B. ; Wasif, Nabil ; Farma, Jeffrey M. ; Averbook, Bruce J. ; Bilimoria, Karl Y. ; Tyler, Douglas ; Brady, Mary Sue ; Farley, David R. / Laparoscopic skill assessment of practicing surgeons prior to enrollment in a surgical trial of a new laparoscopic procedure. In: Surgical Endoscopy and Other Interventional Techniques. 2016 ; pp. 1-7.
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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.",
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AU - Zendejas, Benjamin

AU - Jakub, James W

AU - Terando, Alicia M.

AU - Sarnaik, Amod

AU - Ariyan, Charlotte E.

AU - Faries, Mark B.

AU - Zani, Sabino

AU - Neuman, Heather B.

AU - Wasif, Nabil

AU - Farma, Jeffrey M.

AU - Averbook, Bruce J.

AU - Bilimoria, Karl Y.

AU - Tyler, Douglas

AU - Brady, Mary Sue

AU - Farley, David R.

PY - 2016/12/7

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N2 - 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.

AB - 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.

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KW - Groin dissection

KW - Inguinal

KW - Laparoscopy

KW - Learning curve

KW - Melanoma

KW - Minimally invasive

KW - Simulation

KW - Videoscopic

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