A Phase 3 interventional study of Clermont-Ferrand Uterine Manipulator and No uterine Manipulator in Endometrial Cancer, sponsored by Catholic University of the Sacred Heart. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-05-04.
Sponsored by Catholic University of the Sacred Heart · Phase 3, Interventional, and Treatment
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.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's planned enrollment of 154 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Catholic University of the Sacred Heart is the lead sponsor of 227 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
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77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer using uterine manipulator.
Device: Clermont-Ferrand Uterine Manipulator
77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer without support of uterine manipulator.
Other: No 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)
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)
Upstaging rate
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
Time frame: 30 days
Complications
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.
Time frame: within 30 days from surgery
Blood Loss
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
Time frame: Intraoperative
Impact of surgical procedure
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.
Time frame: Perioperative
Role of uterine manipulator in Obesity
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
Time frame: Intraoperative
Impact on postoperative pain
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.
Time frame: Postoperative
Oncological Outcomes: Rate of local relapses
To investigate if the use or not of uterine manipulator could determine an higher rate of local relapses
Time frame: 1 years - 5 years
Plan to share: Undecided
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This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Catholic University of the Sacred Heart