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

Phase 3

• Conditions: Endometrial Cancer
• Interventions: Device: Clermont-Ferrand Uterine Manipulator; Other: No uterine Manipulator

• Registration Number: NCT02762214
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-04-16
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-02
• Last Update Submitted: 2016-05-02
• Study First Posted: 2016-05-04
• Last Update Posted: 2016-05-04
• Primary Completion: 2016-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With Uterine Manipulator	Clermont-Ferrand Uterine Manipulator	77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer using uterine manipulator.
Without Uterine Manipulator	No uterine Manipulator	77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer without support of uterine manipulator.

Primary Outcome Measures

Name	Time	Method
Upstaging rate	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

Secondary Outcome Measures

Name	Time	Method
Blood Loss	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
Complications	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.
Impact on postoperative pain	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.
Impact of surgical procedure	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.
Role of uterine manipulator in Obesity	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
Oncological Outcomes: Rate of local relapses	1 years - 5 years	To investigate if the use or not of uterine manipulator could determine an higher rate of local relapses

Trial Locations

Locations (1)

Division of Oncologic Gynecology, Fondazione Policlinico Gemelli; 🇮🇹 Rome, Italy