Annals of surgical oncology · 2017
A Minimally Invasive Approach for Inguinal Lymphadenectomy in Melanoma and Genitourinary Malignancy: Long-Term Outcomes in an Attempted Randomized Control Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Postlewait Lauren M, Farley Clara R, Diller Maggie L, Martin Benjamin, Hart Squires M, Russell Maria C, Rizzo Monica, Ogan Kenneth, Master Viraj, Delman Keith
Аннотация
BACKGROUND: Open inguinal lymphadenectomy (OIL) has a high incidence of complications. The authors adapted and reported a minimally invasive technique [videoscopic inguinal lymphadenectomy (VIL)] for use with melanoma, subsequently pursuing a randomized, prospective trial comparing open and minimally invasive approaches in an attempt to confirm retrospective findings illustrating reduced complications with the minimally invasive approach.
METHODS: A randomized, prospective trial (NCT01526486) was designed to compare outcomes for patients undergoing VIL versus OIL. Patients with a diagnosis of malignancies requiring inguinal lymphadenectomy at Emory University were enrolled in the study, and informed consent was obtained. Failure to accrue sufficient patients resulted in suspension of the randomization process. Clinicopathologic, procedural, and outcomes data on VILs were prospectively collected. The primary outcome was wound complications, and the secondary outcome was recurrence-free survival.
RESULTS: The results are limited to VILs. In this study, 102 patients underwent 137 procedures. Most of the complications were Clavien-Dindo 1 or 2, accounting for 89.7% of all postoperative issues. The wound infection rate was 47.4%. Skin necrosis or wound dehiscence occurred after 13 of the procedures (9.5%). For the patients with melanoma, the median overall survival was 68.8 months, and the recurrence-free survival was 18.5 months. The median inguinal recurrence-free survival was not reached. The median stage-specific recurrence-free survival was not reached for stage IIIA, was 22.8 months for stage IIIB, and was 8.8 months for stage IIIC disease (p < 0.001).
CONCLUSIONS: The long-term findings presented in this report expand on and confirm previously published results demonstrating decreased morbidity and oncologic noninferiority of VIL, further validating the technique for patients requiring lymphadenectomy.
METHODS: A randomized, prospective trial (NCT01526486) was designed to compare outcomes for patients undergoing VIL versus OIL. Patients with a diagnosis of malignancies requiring inguinal lymphadenectomy at Emory University were enrolled in the study, and informed consent was obtained. Failure to accrue sufficient patients resulted in suspension of the randomization process. Clinicopathologic, procedural, and outcomes data on VILs were prospectively collected. The primary outcome was wound complications, and the secondary outcome was recurrence-free survival.
RESULTS: The results are limited to VILs. In this study, 102 patients underwent 137 procedures. Most of the complications were Clavien-Dindo 1 or 2, accounting for 89.7% of all postoperative issues. The wound infection rate was 47.4%. Skin necrosis or wound dehiscence occurred after 13 of the procedures (9.5%). For the patients with melanoma, the median overall survival was 68.8 months, and the recurrence-free survival was 18.5 months. The median inguinal recurrence-free survival was not reached. The median stage-specific recurrence-free survival was not reached for stage IIIA, was 22.8 months for stage IIIB, and was 8.8 months for stage IIIC disease (p < 0.001).
CONCLUSIONS: The long-term findings presented in this report expand on and confirm previously published results demonstrating decreased morbidity and oncologic noninferiority of VIL, further validating the technique for patients requiring lymphadenectomy.