Status:
COMPLETED
Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Abnormal Uterine Bleeding
Uterine Bleeding
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
The purpose of the study is to investigate differences in perioperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in participants under...
Detailed Description
The purpose of the proposed study is to investigate differences in intraoperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in subjects...
Eligibility Criteria
Inclusion
- All benign total laparoscopic hysterectomy and/or robotic-assisted hysterectomy, +/- unilateral salpingo-oophorectomy or bilateral salpingo-oophorectomy
- Adnexectomy, cystectomy, tubal procedures at time of hysterectomy
- Age \>18 years old
- Uterus \>12 weeks, or \>250 grams (based on imaging), or requiring morcellation based on clinical judgment at time of pre-operative enrollment
- English and Spanish speaking
Exclusion
- Pre-malignant conditions (i.e. endometrial intraepithelial neoplasia, high-grade cervical intraepithelial neoplasia), known gynecologic malignancy, and any contraindications to abdominal or vaginal morcellation
- Planned concurrent procedures (i.e. hernia repair, bowel resections, anti-incontinence procedures, prolapse repair, and mastectomy)
- Appendectomy for endometriosis is not excluded
- No chronic pain disorders requiring medical management (endometriosis can be included)
- Planned abdominal hysterectomy or vaginal hysterectomy candidates
- Conversion to laparotomy or inability to complete morcellation
- Contraindications to laparoscopy
Key Trial Info
Start Date :
January 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04434066
Start Date
January 8 2020
End Date
November 5 2024
Last Update
November 8 2024
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75229