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

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Brief Title

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

Official Title

Role Of Uterine Manipulator in Hysterectomy for Early Stage Endometrial Cancer

Brief 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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Upstaging rate

Secondary Outcome

 Complications

Condition

Endometrial Cancer

Intervention

Clermont-Ferrand Uterine Manipulator

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

154

Start Date

October 2015

Completion Date

October 2017

Primary Completion Date

October 2016

Eligibility Criteria

        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

Gender

Female

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Italy

Location Countries

Italy

Administrative Informations

NCT ID

NCT02762214

Organization ID

RoManHy

Responsible Party

Principal Investigator

Study Sponsor

Catholic University of the Sacred Heart

Study Sponsor

, ,

Verification Date

May 2016