Status:
COMPLETED
Surgical Success After Laparoscopic vs Abdominal Hysterectomy
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Metrorrhagia
Menorrhagia
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety, and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to abdominal hysterecto...
Detailed Description
The overall hypothesis is that neither mode of hysterectomy will be consistently superior to the other with respect to each of the three domains of complications, cost, and patient-centered outcomes. ...
Eligibility Criteria
Inclusion
- Women undergoing hysterectomy for benign indications within 8 weeks of enrollment
- Women \>18 years of age
- Non-emergent surgery
- Non-pregnant
Exclusion
- Candidate for vaginal hysterectomy
- Uterine size \>14 weeks by clinical exam OR \>300 mL by ultrasound measurement
- History of cancer of reproductive tract
- Requires concomitant pelvic organ prolapse (POP) surgery
- Requires surgery for urinary incontinence
- Has acute angle glaucoma
- Has severe cardiac/respiratory disease
- Desires supracervical hysterectomy
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01793584
Start Date
February 1 2013
End Date
December 31 2016
Last Update
October 26 2017
Active Locations (1)
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1
Parkland Hospital
Dallas, Texas, United States, 75235