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

C

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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