NCT02762214

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

Role Of Uterine Manipulator in Hysterectomy for Early Stage Endometrial Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-10-01
• Completion: 2017-10-01
• First posted: 2016-05-04
• Last updated: 2016-05-04

Locations

1 site across 1 country: Italy