Endometrial Cancer
Conditions
Keywords
Uterin manipulator, Endometrial Cancer, Laparoscopy, Robotic
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.
Interventions
DEVICEClermont-Ferrand Uterine Manipulator
Pelvic cytology is obtained before starting surgical procedures (washing number 1). After tubal coagulation, Clermont-Ferrand Uterine Manipulator is installed inside the uterus. At the end of the hysterectomy, after colporrhaphy, a second cytology is obtained (washing number 2)
OTHERNo uterine Manipulator
Pelvic cytology is obtained before starting surgical procedures (washing number 1). None uterine manipulator is used and the cervix is closed with a cross stitch. Tubal coagulation, At the end of the hysterectomy, after colporrhaphy, a second cytology is obtained (washing number 2)
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upstaging rate | 30 days | Evaluation of Lymphovascular space invasion and pre- / post-Hysterectomy pelvic cytology in order to investigate if the use of uterine manipulator has a role in upstaging of early-stage endometrial cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | within 30 days from surgery | To measure intra- and postoperative complication rate in order to investigate the specific role of uterine manipulator in complication occurred during hysterectomy or within 30 days after. |
| Blood Loss | Intraoperative | To measure intraoperative estimated blood loss (EBL) in order to investigate the specific role of uterine manipulator in hemostatic control during Hysterectomy safety of laparoscopic hysterectomy |
| Impact of surgical procedure | Perioperative | To measure the specific role of uterine manipulator in impact on surgery. More in dept operative time (OT), ileus, discharge time will be respectively measured in minutes, hours and days. |
| Impact on postoperative pain | Postoperative | To investigate if the use or not of uterine manipulator could have a role in postoperative pain. Visual Analog Score (VAS) will be used to evaluate it. |
| Oncological Outcomes: Rate of local relapses | 1 years - 5 years | To investigate if the use or not of uterine manipulator could determine an higher rate of local relapses |
| Role of uterine manipulator in Obesity | Intraoperative | To determine the specific correlations between the use or not of uterine manipulator and Body Mass Index (BMI measured in kg/m2). To investigate if even this issue could influence the intraoperative safety |
Countries
Italy
Outcome results
None listed