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

Catholic University of the Sacred Heart

Status and phase: Unknown; Phase 3

Conditions: Endometrial Cancer

Treatments: Device: Clermont-Ferrand Uterine Manipulator; Other: No uterine Manipulator

Study type: Interventional

Funder types: Other

Identifiers

NCT02762214

RoManHy

Details and patient eligibility

About

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).

Full 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.

Enrollment: 154 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

With Uterine Manipulator

Active Comparator group

Description:

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

Treatment:

Device: Clermont-Ferrand Uterine Manipulator

Without Uterine Manipulator

Experimental group

Description:

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

Treatment:

Other: No uterine Manipulator