Status:
COMPLETED
Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy
Lead Sponsor:
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18-85 years
Brief Summary
Utero-vaginal prolapse is a common, often disabling, condition experienced by women of varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes vaginal hysterectomy a...
Detailed Description
Utero-vaginal prolapse is a common, often disabling, condition experienced by women of varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes vaginal hysterectomy a...
Eligibility Criteria
Inclusion
- patients who are over 35 years of age with no desire to preserve fertility. (Subjects had completed childbearing or were practicing reliable contraception)
- have a normal size uterus (\<10 cm) on examination or ultrasound
- who agree to participate in principle will be given further information about the trial and consent will be obtained either in an outpatient clinic or at the next visit for preoperative assessment.
Exclusion
- cervical elongation (surgeon discretion),
- prior mesh prolapse repair,
- current foreign-body complications,
- increased risk or recent history of cervical dysplasia, chronic pelvic pain, significant uterine abnormalities, and abnormal menstruation.
- postmenopausal bleeding in the past 12 months
- women with a significantly enlarged fibroid uterus
- concomitant medical problems precluding general anesthesia or the use of a steep trendelenberg position
Key Trial Info
Start Date :
February 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03436147
Start Date
February 1 2018
End Date
February 1 2020
Last Update
September 25 2020
Active Locations (1)
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1
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Turkey (Türkiye), 34147