Role of Uterine Manipulator in Hysterectomy - Ro.Man.HY
NCT ID: NCT02762214
Last Updated: 2016-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
154 participants
INTERVENTIONAL
2015-10-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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With Uterine Manipulator
77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer using uterine manipulator.
Clermont-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)
Without Uterine Manipulator
77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer without support of uterine manipulator.
No 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)
Interventions
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Clermont-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)
No 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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
FEMALE
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Responsible Party
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Prof. Giovanni Scambia
Professor
Locations
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Division of Oncologic Gynecology, Fondazione Policlinico Gemelli
Rome, Rome, Italy
Countries
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Facility Contacts
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Other Identifiers
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RoManHy
Identifier Type: -
Identifier Source: org_study_id
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