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

Role Of Uterine Manipulator in Hysterectomy for Early Stage Endometrial Cancer

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).

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.

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