Role of Uterine Manipulator in Hysterectomy - Ro.Man.HY (RoManHy)

May 2, 2016 updated by: Prof. Giovanni Scambia, Catholic University of the Sacred Heart

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

154

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Recruiting
        • Division of Oncologic Gynecology, Fondazione Policlinico Gemelli
        • Contact:
        • Principal Investigator:
          • Giovanni Scambia, Prof
        • Sub-Investigator:
          • Francesco Fanfani, Prof
        • Sub-Investigator:
          • Stefano Cianci, MD
        • Sub-Investigator:
          • Gian Franco Zannoni, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: With Uterine Manipulator
77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer using uterine manipulator.
Device: Clermont-Ferrand Uterine Manipulator

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)
EXPERIMENTAL: Without Uterine Manipulator
77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer without support of uterine manipulator.
Other: No uterine Manipulator

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: within 30 days from surgery
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.
within 30 days from surgery
Blood Loss
Time Frame: Intraoperative
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
Intraoperative
Impact of surgical procedure
Time Frame: Perioperative
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.
Perioperative
Role of uterine manipulator in Obesity
Time Frame: Intraoperative
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
Intraoperative
Impact on postoperative pain
Time Frame: Postoperative
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.
Postoperative
Oncological Outcomes: Rate of local relapses
Time Frame: 1 years - 5 years
To investigate if the use or not of uterine manipulator could determine an higher rate of local relapses
1 years - 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

October 1, 2016

Study Completion (ANTICIPATED)

October 1, 2017

Study Registration Dates

First Submitted

April 16, 2016

First Submitted That Met QC Criteria

May 2, 2016

First Posted (ESTIMATE)

May 4, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 4, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RoManHy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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