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

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.