Long-term oncological outcomes of the ROMANHY trial: impact of intrauterine manipulator during minimally invasive surgery for early-stage endometrial cancer.

STUDY OBJECTIVE: The ROMANHY trial (NCT02762214) was a multicenter randomized study originally designed to assess the impact of intrauterine manipulator (IUM) use on lymphovascular space invasion (LVSI) during minimally invasive staging surgery for presumed early-stage endometrial cancer (EC). This extended follow-up analysis evaluated whether IUM use was associated with long-term oncologic outcomes. DESIGN: Multicenter randomized controlled trial with long-term follow-up. SETTING: Five tertiary referral centers in Italy. PATIENTS: A total of 154 patients with presumed FIGO 2009 stage I, endometrioid low-grade (G1-G2) EC undergoing minimally invasive surgery between October 2015 and December 2017. INTERVENTIONS: Patients were randomized 1:1 to minimally invasive hysterectomy performed with or without a Clermont-Ferrand intrauterine manipulator. MEASUREMENTS AND MAIN RESULTS: After a median follow-up of 96.8 months (95% CI 94.3-98.5), 16 recurrences and 9 deaths occurred, including 5 cancer-specific deaths. No differences were observed between groups in LVSI (p=0.501), disease-free survival (p=0.910), overall survival (p=0.837), or cancer-specific survival (p=0.566). On multivariable analysis, only FIGO stage independently predicted disease-free survival (HR2009 6.93, p=0.001; HR2023 12.53, p<0.0001), whereas IUM use did not (HR 1.08, p=0.876). CONCLUSION: In this randomized trial, IUM use during minimally invasive staging for presumed early-stage low-grade EC was not associated with worse oncologic outcomes after extended follow-up (median 96.8 months) in this selected low-risk population. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02762214, registered May 2 2016. https://clinicaltrials.gov/study/NCT02762214.