Endometrial CancerPhase 3RoManHyNCT02762214
Role of Uterine Manipulator in Hysterectomy - Ro.Man.HY
A Phase 3 study testing Clermont-Ferrand Uterine Manipulator and No uterine Manipulator in people with Endometrial Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Clermont-Ferrand Uterine Manipulator and No uterine Manipulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2015to Oct 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- For diseases
- Early stage endometrial cancer (IA-IB)
- Endometrioid histotype (G1-G2)
Who cannot join
- For patients
- Age > 18 < 80
- Actual pregnancies
- Previous gynecological cancer
- For disease
- Type II endometrial cancer histotype
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Division of Oncologic Gynecology, Fondazione Policlinico Gemelli
Rome, Rome, 00168
Salvatore Gueli Alletti, +390630158545, salvatore.guelialletti@policlinicogemelli.it
Giovanni Scambia, Prof
About this study
Official title: Role Of Uterine Manipulator in Hysterectomy for Early Stage Endometrial Cancer
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).
Read the detailed description
This multicentric prospective randomized Phase III trial is aimed to verify if the use of uterine manipulator for laparoscopic/robotic treatment of early stage endometrial cancer can influence the impact of peritoneal cytology and lymph vascular space invasion (LVSI) and the outcomes in terms of perioperative and oncological (disease free survival - DFS, overall survival - OS) outcomes.
- Conditions
- Endometrial Cancer
- Being tested
- Clermont-Ferrand Uterine Manipulator, No uterine Manipulator
- Keywords
- Uterin manipulator, Endometrial Cancer, Laparoscopy, Robotic
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clermont-Ferrand Uterine ManipulatorDevice
Pelvic cytology is obtained before starting surgical procedures (washing number 1).
After tubal coagulation, Clermont-Ferrand Uterine Manipulator is installed inside the uterus. At the end of the hysterectomy, after colporrhaphy, a second cytology is obtained (washing number 2)
No uterine ManipulatorOther
Pelvic cytology is obtained before starting surgical procedures (washing number 1). None uterine manipulator is used and the cervix is closed with a cross stitch.
Tubal coagulation, At the end of the hysterectomy, after colporrhaphy, a second cytology is obtained (washing number 2)
| Study group | Role | What they receive |
|---|---|---|
| With Uterine Manipulator | Active comparator | 77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer using uterine manipulator. Receives: Device: Clermont-Ferrand Uterine Manipulator |
| Without Uterine Manipulator | Experimental | 77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer without support of uterine manipulator. Receives: Other: No uterine Manipulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upstaging rate
Evaluation of Lymphovascular space invasion and pre- / post-Hysterectomy pelvic cytology in order to investigate if the use of uterine manipulator has a role in upstaging of early-stage endometrial cancer
Measured: 30 days
Secondary outcomes (6)
Complications
To measure intra- and postoperative complication rate in order to investigate the specific role of uterine manipulator in complication occurred during hysterectomy or within 30 days after.
Measured: within 30 days from surgery
Blood Loss
To measure intraoperative estimated blood loss (EBL) in order to investigate the specific role of uterine manipulator in hemostatic control during Hysterectomy safety of laparoscopic hysterectomy
Measured: Intraoperative
Impact of surgical procedure
To measure the specific role of uterine manipulator in impact on surgery. More in dept operative time (OT), ileus, discharge time will be respectively measured in minutes, hours and days.
Measured: Perioperative
Role of uterine manipulator in Obesity
To determine the specific correlations between the use or not of uterine manipulator and Body Mass Index (BMI measured in kg/m2). To investigate if even this issue could influence the intraoperative safety
Measured: Intraoperative
Impact on postoperative pain
To investigate if the use or not of uterine manipulator could have a role in postoperative pain. Visual Analog Score (VAS) will be used to evaluate it.
Measured: Postoperative
Oncological Outcomes: Rate of local relapses
To investigate if the use or not of uterine manipulator could determine an higher rate of local relapses
Measured: 1 years - 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Giovanni Scambia, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762214
- Sponsor's protocol ID
- RoManHy
- Acronym
- RoManHy
- Status last verified
- May 2016
- First submitted
- 16 Apr 2016
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Perrone 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.
PubMed 42586310
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Uterine Manipulator in Hysterectomy for Early Stage Endometrial Cancer
- ClinicalTrials.gov ID
- NCT02762214
- Acronym / sponsor ID
- RoManHy / RoManHy
- Conditions
- Endometrial Cancer
- Keywords
- Uterin manipulator, Endometrial Cancer, Laparoscopy, Robotic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This multicentric prospective randomized Phase III trial is aimed to verify if the use of uterine manipulator for laparoscopic/robotic treatment of early stage endometrial cancer can influence the impact of peritoneal cytology and lymph vascular space invasion (LVSI) and the outcomes in terms of perioperative and oncological (disease free survival - DFS, overall survival - OS) outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Uterine Manipulator | Active comparator | Device: Clermont-Ferrand Uterine Manipulator77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer using uterine manipulator. |
| Without Uterine Manipulator | Experimental | Other: No uterine Manipulator77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer without support of uterine manipulator. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- For patients
- Age > 18 < 80 years
- Patient's informed consent
- American Society of Anesthesiologists: < class III or IV
- No actual pregnancies
Key exclusion criteria (11 listed)
- For patients
- Age > 18 < 80
- Actual pregnancies
- Previous gynecological cancer
- For disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clermont-Ferrand Uterine ManipulatorPelvic cytology is obtained before starting surgical procedures (washing number 1). After tubal coagulation, Clermont-Ferrand Uterine Manipulator is installed inside the uterus. At the end of the hysterectomy, after colporrhaphy, a second cytology is obtained (washing number 2) | Device | With Uterine Manipulator |
| No uterine ManipulatorPelvic cytology is obtained before starting surgical procedures (washing number 1). None uterine manipulator is used and the cervix is closed with a cross stitch. Tubal coagulation, At the end of the hysterectomy, after colporrhaphy, a second cytology is obtained (washing number 2) | Other | Without Uterine Manipulator |
Primary outcome
Upstaging rate
Time frame: 30 days
Evaluation of Lymphovascular space invasion and pre- / post-Hysterectomy pelvic cytology in order to investigate if the use of uterine manipulator has a role in upstaging of early-stage endometrial cancer
6 secondary outcomes
Complications
Time frame: within 30 days from surgery
Blood Loss
Time frame: Intraoperative
Impact of surgical procedure
Time frame: Perioperative
Role of uterine manipulator in Obesity
Time frame: Intraoperative
Impact on postoperative pain
Time frame: Postoperative
Oncological Outcomes: Rate of local relapses
Time frame: 1 years - 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Derived from this study: PubMed 42586310Perrone 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Division of Oncologic Gynecology, Fondazione Policlinico Gemelli
Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clermont-Ferrand Uterine Manipulator and No uterine Manipulator in people with Endometrial Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upstaging rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02762214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.