Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy (NCT04434066) | Clinical Trial Compass
CompletedNot Applicable
Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy
United States46 participantsStarted 2020-01-08
Plain-language 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 undergoing laparoscopic total hysterectomies in a randomized controlled trial.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Mean difference in total operating room time
Timeframe: intraoperative
Trial details
NCT IDNCT04434066
SponsorUniversity of Texas Southwestern Medical Center