Journal of minimally invasive gynecology · 2026
Long-term Oncological Outcomes of the ROMANHY Trial: Impact of Intrauterine Manipulator During Minimally Invasive Surgery for Early-Stage Endometrial Cancer.
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Perrone Emanuele, Parisi Giuseppe, Pasciuto Tina, Gueli Alletti Salvatore, Giuliano Maria Consiglia, Capasso Ilaria, Palmieri Emilia, Aprea Dario, Tarantino Vincenzo, Pirrelli Fulvia, Esposito Giovanni, Fossatelli Alessia, Fanfani Francesco
Аннотация
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 = .501), disease-free survival (p = .910), overall survival (p = .837), or cancer-specific survival (p = .566). On multivariable analysis, only FIGO stage independently predicted disease-free survival (HR2009 6.93, p = .001; HR2023 12.53, p <.001), whereas IUM use did not (HR 1.08, p = .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 a selected low-risk population.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT02762214, registered May 2, 2016. https://clinicaltrials.gov/study/NCT02762214.
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 = .501), disease-free survival (p = .910), overall survival (p = .837), or cancer-specific survival (p = .566). On multivariable analysis, only FIGO stage independently predicted disease-free survival (HR2009 6.93, p = .001; HR2023 12.53, p <.001), whereas IUM use did not (HR 1.08, p = .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 a selected low-risk population.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT02762214, registered May 2, 2016. https://clinicaltrials.gov/study/NCT02762214.