Sahar Salehi1, Elisabeth Åvall-Lundqvist2, Berit Legerstam3, Joseph W Carlson4, Henrik Falconer5. 1. Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden; Division of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden. Electronic address: sahar.salehi@sll.se. 2. Department of Oncology, Linköping University, Linköping, Sweden; Department of Clinical Experimental Medicine, Linköping University, Linköping, Sweden; Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden. 3. Division of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden. 4. Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden; Department of Pathology and Cytology, Karolinska University Hospital, Stockholm, Sweden. 5. Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden; Division of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden.
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.
RCT Entities:
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.
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