Status:
NOT_YET_RECRUITING
Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Pelvic Organ Prolapse
Gynecologic Disorders
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Randomized prospective monocentric interventional study to compare learning curves for traditional vaginal hysterectomy and vaginal hysterectomy performed by bipolar coagulation comparing short-term o...
Detailed Description
This is a prospective, randomized, spontaneous monocentric interventional study on a procedure in which 60 female patients will be enrolled with a diagnosis of pelvic organs prolapse which are eligibl...
Eligibility Criteria
Inclusion
- Women aged \>18 years
- Genital prolapse \> II degree in accordance with the "POP-Q System" eligible for vaginal hysterectomy
- Understanding and signing of informed consent for surgical procedure
Exclusion
- Need for simultaneous bilateral adnexectomy
- Previous cesarian section
- Patients with abdominal laparoscopic or laparotomy history
- Patients with malignant pathology and/or adnexal pathology
- Confirmed or presumed pregnancy
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06220253
Start Date
June 1 2024
End Date
March 1 2025
Last Update
May 21 2024
Active Locations (1)
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1
Arianna Casiraghi
Milan, Italy, 20159