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