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

Primary Purpose

Endometrial Cancer

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Clermont-Ferrand Uterine Manipulator
No uterine Manipulator
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring Uterin manipulator, Endometrial Cancer, Laparoscopy, Robotic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Oncologic Gynecology, Fondazione Policlinico GemelliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

With Uterine Manipulator

Without Uterine Manipulator

Arm Description

77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer using uterine manipulator.

77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer without support of uterine manipulator.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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.
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
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.
Oncological Outcomes: Rate of local relapses
To investigate if the use or not of uterine manipulator could determine an higher rate of local relapses

Full Information

First Posted
April 16, 2016
Last Updated
May 2, 2016
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT02762214
Brief Title
Role of Uterine Manipulator in Hysterectomy - Ro.Man.HY
Acronym
RoManHy
Official Title
Role Of Uterine Manipulator in Hysterectomy for Early Stage Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Uterin manipulator, Endometrial Cancer, Laparoscopy, Robotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
With Uterine Manipulator
Arm Type
Active Comparator
Arm Description
77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer using uterine manipulator.
Arm Title
Without Uterine Manipulator
Arm Type
Experimental
Arm Description
77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer without support of uterine manipulator.
Intervention Type
Device
Intervention Name(s)
Clermont-Ferrand Uterine Manipulator
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
No uterine Manipulator
Intervention Description
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)
Primary Outcome Measure Information:
Title
Upstaging rate
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Complications
Description
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.
Time Frame
within 30 days from surgery
Title
Blood Loss
Description
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
Time Frame
Intraoperative
Title
Impact of surgical procedure
Description
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.
Time Frame
Perioperative
Title
Role of uterine manipulator in Obesity
Description
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
Time Frame
Intraoperative
Title
Impact on postoperative pain
Description
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.
Time Frame
Postoperative
Title
Oncological Outcomes: Rate of local relapses
Description
To investigate if the use or not of uterine manipulator could determine an higher rate of local relapses
Time Frame
1 years - 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Oncologic Gynecology, Fondazione Policlinico Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatore Gueli Alletti
Phone
+390630158545
Email
salvatore.guelialletti@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Giovanni Scambia, Prof
First Name & Middle Initial & Last Name & Degree
Salvatore Gueli Alletti, MD
First Name & Middle Initial & Last Name & Degree
Anna Fagotti, PhD
First Name & Middle Initial & Last Name & Degree
Francesco Fanfani, Prof
First Name & Middle Initial & Last Name & Degree
Stefano Cianci, MD
First Name & Middle Initial & Last Name & Degree
Gian Franco Zannoni, Prof

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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