Role of Uterine Manipulator in Hysterectomy - Ro.Man.HY

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role Of Uterine Manipulator in Hysterectomy for Early Stage Endometrial Cancer

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Device: Clermont-Ferrand Uterine Manipulator
* Other: No uterine Manipulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: With Uterine Manipulator<br>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<br>* 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)<br>|
| Experimental: Without Uterine Manipulator<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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 | 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. | 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 | 1 years - 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterin manipulator, Endometrial Cancer, Laparoscopy, Robotic