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

Endometrial Cancer Clinical Trial

— RoManHy  

Official title:

Role Of Uterine Manipulator in Hysterectomy for Early Stage Endometrial Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02762214
• Other study ID #: RoManHy
• Status: Recruiting
• Phase: Phase 3
• First received: April 16, 2016
• Last updated: May 2, 2016
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: May 2016
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer

Intervention

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)

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)

Locations

Country	Name	City	State
Italy	Division of Oncologic Gynecology, Fondazione Policlinico Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes