Robot-assisted laparoscopy versus laparotomy for infrarenal paraaortic lymphadenectomy in women with high-risk endometrial cancer: A randomised controlled trial

Eur J Cancer. 2017 Jul;79:81-89. doi: 10.1016/j.ejca.2017.03.038. Epub 2017 Apr 29.

Abstract

Purpose: To investigate if robot-assisted laparoscopic surgery (RALS) was non-inferior to laparotomy (LT) in harvesting infrarenal paraaortic lymph nodes in patients with presumed stage I-II high-risk endometrial cancer.

Patients and methods: Patients with histologically proven endometrial cancer, presumed stage I-II with high-risk tumour features, were randomised to hysterectomy, bilateral salpingo-oophorectomy, pelvic and paraaortic lymphadenectomy by either RALS or LT. Primary outcome was paraaortic lymph node count. Secondary outcomes were perioperative events, postoperative complications and total health care cost.

Results: Overall 120 patients were randomised and 96 patients were included in the per protocol analysis. Demographic, clinical and tumour characteristics were evenly distributed between groups. Mean (±SD) paraaortic lymph node count was 20.9 (±9.6) for RALS and 22 (±11, p = 0.45) for LT. The difference of means was within the non-inferiority margin (-1.6, 95% CI -5.78, 2.57). Mean pelvic node count was lower after RALS (28 ± 10 versus 22 ± 8, p < 0.001). There was no difference in perioperative complications or readmissions between the groups. Operation time was longer (p < 0.001) but total blood loss less (<0.001) and hospital stay shorter (<0.001) in RALS group than LT group. Health care costs for RALS was significantly lower (mean difference $1568 USD/€1225 Euro, p < 0.05).

Conclusion: Our results demonstrate non-inferiority in paraaortic lymph node count, comparable complication rates, shorter hospital length and lower total cost for RALS over laparotomy. Generalisability of the latter finding requires a high-volume setting and high surgical proficiency. In women with high-risk endometrial cancer confined to the uterus, RALS is a valid treatment modality.

Clinical trials registrations: ClinicalTrials.govNCT01847703.

Keywords: Endometrial cancer; Laparotomy; Lymph node count; Paraaortic lymphadenectomy; Robotic surgery.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Blood Loss, Surgical / statistics & numerical data
  • Endometrial Neoplasms / surgery*
  • Female
  • Humans
  • Hysterectomy / methods
  • Laparoscopy / methods*
  • Length of Stay
  • Lymph Node Excision / methods*
  • Lymphatic Metastasis
  • Middle Aged
  • Operative Time
  • Ovariectomy / methods
  • Robotic Surgical Procedures / methods*
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT01847703
  • ClinicalTrials.gov/NCT01847703