Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma (SAFE-MILND)

Jakub, James W.; Terando, Alicia M.; Sarnaik, Amod A.; Ariyan, Charlotte E.; Faries, Mark B.; Zani, Sabino; Neuman, Heather B.; Wasif, Nabil; Farma, Jeffrey M.; Averbook, Bruce J.; Bilimoria, Karl Y.; Grotz, Travis E.; Allred, Jacob B.; Suman, Vera J.; Brady, Mary S.; Tyler, Douglas S.; Wayne, Jeffrey D.

doi:10.1097/sla.0000000000001670

Cited by 43 publications

(33 citation statements)

References 33 publications

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“…Replacement of the large inguinal incision by three smaller incisions away from the inguinal skinfold might offer a solution via a minimally invasive technique, namely, videoscopic inguinofemoral lymphadenectomy. This procedure is accompanied by a lower complication rate in other centers and has a comparable oncologic outcome 25–27. Because all other adjustments in perioperative care and management have failed, this procedure might be a promising method for reducing wound complications after ILNDs.…”

Section: Discussionmentioning

confidence: 99%

Morbidity After Inguinal Lymph Node Dissections: It Is Time for a Change

et al. 2016

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BackgroundInguinal lymph node dissection (ILND) for stage 3 melanoma is accompanied by high wound complication rates. During the past decades, several changes in perioperative care have been instituted to decrease the incidence of these complications. This study aimed to evaluate the effect of these different care protocols on wound complications after ILND.MethodsA retrospective analysis of prospectively collected data was performed with 240 patients who underwent an ILND in the University Medical Center Groningen between 1989 and 2014. Four groups with different treatment protocols were analyzed: A (≥10 days of bed rest with a Bohler Braun splint), B (10 days of bed rest without a splint), C (5 days of bed rest), and D (1 day of bed rest). The effect of early mobilization, abolishment of the Bohler Braun splint and postural restrictions, and the introduction of prophylactic antibiotics were analyzed.ResultsOne or more wound complications occurred in 51.2 % of the patients including wound infection (29.8 %), seroma (21.5 %), wound necrosis (13.6 %), and hematoma (5 %). In consecutive periods, respectively 44.4, 60.3, 44.9 and 55.2 % of the patients experienced wound complications. None of the instituted changes in protocols led to a decrease in wound complications.ConclusionChanges in perioperative care protocols did not affect the rate of wound complications. Perhaps a change in the surgical procedure itself can lead to the necessary reduction of wound complications after ILND.

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Section: Discussionmentioning

confidence: 99%

Morbidity After Inguinal Lymph Node Dissections: It Is Time for a Change

et al. 2016

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“…The Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection trial (SAFE-MILND, NCT01500304) is a prospective, multicenter, phase I/II clinical trial in which established melanoma surgeons were trained in a novel procedure, specifically the minimally invasive technique to perform an inguinal lymphadenectomy (MILND) [9, 10]. The primary aim of the trial was to evaluate the safety and feasibility of the MILND in the treatment of melanoma and have been previously published [9, 10].…”

Section: Methodsmentioning

confidence: 99%

“…The primary aim of the trial was to evaluate the safety and feasibility of the MILND in the treatment of melanoma and have been previously published [9, 10]. For this manuscript, we focus on the pre-trial FLS assessment and the relationship of such with certain trial metrics as described below.…”

Section: Methodsmentioning

confidence: 99%

“…Training sessions were standardized and occurred on two separate dates at Mayo Clinic, Rochester, Minnesota. Complete details of the training intervention have been previously published [9, 10]. Prior to any educational intervention, participants underwent baseline assessment of their basic laparoscopic skills with the FLS assessment program [6].…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2016

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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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“…The lnrr can also serve as an entry criterion for patients enrolling in randomized controlled trials for adjuvant therapy. Furthermore, as novel surgical approaches such as minimally invasive inguinal lymph node dissection are incorporated into surgical care, reviewing the lnrr of those procedures for comparison with our published lnrrs in a conventional open approach can be used to quickly validate the completeness of the new techniques 14 .…”

Section: Discussionmentioning

confidence: 99%