STELLA-2 Randomized Trial
Description
Randomized trial on minimally-invasive (transperitoneal or extraperitoneal) paraaortic lymphadenectomy. The study objective was to evaluate if extraperitoneal paraaortic lymphadenectomy using a robotic-assisted approach was associated with fewer complications when compared to all other approaches (conventional laparoscopic transperitoneal or extraperitoneal and robotic-assisted transperitoneal) without compromising lymph node yield, operative time or length of stay. Design: Exploratory analysis of the prospective randomized open-label multicenter trial (STELLA-2) Setting: Three academic reference hospitals. Patients: Two-hundred and three eligible patients from STELLA-2 trial were included. Interventions: Patients were randomized to extraperitoneal or transperitoneal PALND using a minimally invasive approach (either laparoscopy or robotic-assisted) for surgical staging of endometrial or ovarian cancer. Measurements and Main Results: Primary endpoint was evaluated through a composite variable which included at least one of the following events: bleeding during PALND ≥ 500 mL, any intraoperative complication related to PALND, severe postoperative complication (Dindo ≥ IIIA), impossibility to complete the procedure or conversion to laparotomy). Of the 203 patients analyzed, 68 patients were assigned to the extraperitoneal laparoscopic group (X-L), 62 to the transperitoneal laparoscopic group (T-L), 35 to the extraperitoneal robotic group (X-R), and 38 to the transperitoneal robotic group (T-R). A reduced trend in complications was observed in the extraperitoneal robotic-assisted arm when considering the primary endpoint (X-L: 25.0%, T-L:24.2%, X-R: 5.7%; T-R: 28.9%, p=0.073). In a multivariable analysis, age (OR: 1.05, 95% CI: 1.00-1.09), body mass index (OR: 1.09, 95% CI: 1.03-1.16), and waist-hip ratio (OR: 1.66, 95% CI: 1.12-2.47) were found to independently increase the risk of PALND complications, while extraperitoneal robotic approach (OR: 0.13, 95% CI 0.02-0.64) was an independent protective factor for complication occurrence.
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Steps to reproduce
Data is introduced at: dbstella_data_export_2019.09.06.xlsx Variable codes are described at: dbstella_catlist_export_2019.07.23.xlsx