Clinical trial · Interventional
Role of Uterine Manipulator in Hysterectomy - Ro.Man.HY
Role Of Uterine Manipulator in Hysterectomy for Early Stage Endometrial Cancer
NCT02762214CI-TRIAL-00022010RoManHyunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective multicentric randomized trial to evaluate the role of uterine manipulator on laparoscopic/robotic total hysterectomy for the treatment of early stage G1 - G2 endometrial cancer (International Federation of Gynecology and Obstetrics - FIGO stages IA-IB).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clermont-Ferrand Uterine Manipulator | Device | — | UNRESOLVED |
| No uterine Manipulator | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- With Uterine Manipulator
- description
- 77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer using uterine manipulator.
- interventionNames
- Device: Clermont-Ferrand Uterine Manipulator
- type
- EXPERIMENTAL
- label
- Without Uterine Manipulator
- description
- 77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer without support of uterine manipulator.
- interventionNames
- Other: No uterine Manipulator
Primary outcomes (1)
- measure
- Upstaging rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: For patients * Age \> 18 \< 80 years * Patient's informed consent * American Society of Anesthesiologists: \< class III or IV * No actual pregnancies * Body Mass Index (BMI) ≤ 35 For diseases * Early stage endometrial cancer (IA-IB) * Endometrioid histotype (G1-G2) Exclusion Criteria: For patients * Age \> 18 \< 80 * Actual pregnancies * Previous gynecological cancer For disease * Type II endometrial cancer histotype * Grade 3 endometrial cancer * Advanced stage endometrial cancer (II - IV) * Previous radiotherapy on the pelvic field * Uterine size larger than conform 12 weeks gestation or 9 cm in horizontal * Necessity of laparotomic procedures
References
Publications (1)
- DERIVEDPerrone E, Parisi G, Pasciuto T, Alletti SG, Giuliano MC, Capasso I, Palmieri E, Aprea D, Tarantino V, Pirrelli F, Esposito G, Fossatelli A, Fanfani F. Long-term oncological outcomes of the ROMANHY trial: impact of intrauterine manipulator during minimally invasive surgery for early-stage endometrial cancer. J Minim Invasive Gynecol. 2026 Aug 12:S1553-4650(26)00443-7. doi: 10.1016/j.jmig.2026.08.006. Online ahead of print. PMID 42586310