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

Authors

Emanuele Perrone, Giuseppe Parisi, Tina Pasciuto, Salvatore Gueli Alletti, Maria Consiglia Giuliano, Ilaria Capasso, Emilia Palmieri, Dario Aprea, Vincenzo Tarantino, Fulvia Pirrelli, Giovanni Esposito, Alessia Fossatelli, Francesco Fanfani

Published in

Journal of minimally invasive gynecology. Aug 12, 2026. Epub Aug 12, 2026.

Abstract

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.
Multicenter randomized controlled trial with long-term follow-up.
Five tertiary referral centers in Italy.
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.
Patients were randomized 1:1 to minimally invasive hysterectomy performed with or without a Clermont-Ferrand intrauterine manipulator.
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).
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.
ClinicalTrials.gov, NCT02762214, registered May 2 2016. https://clinicaltrials.gov/study/NCT02762214.

PMID:
42586310
Bibliographic data and abstract were imported from PubMed on 13 Aug 2026.

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