NCT04434066Completed
Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy
A Comparison of Perioperative and Patient-Centered Outcomes with Abdominal Versus Vaginal Morcellation: a Randomized-Controlled Trial
Source: ClinicalTrials.gov · Last updated 8 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 12 Jun 2020
- Start date
- 8 Jan 2020
- Primary completion date
- 19 Jul 2022
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Endometriosis
- NCT number
- NCT04434066
What you commit to
- Study type: Interventional
- Participants enrolled: 46
- From 8 Jan 2020 to the primary completion date, 19 Jul 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned concurrent procedures (i.e. hernia repair, bowel resections, anti-incontinence procedures, prolapse repair, and mastectomy)
Other illness
- Pre-malignant conditions (i.e. endometrial intraepithelial neoplasia, high-grade cervical intraepithelial neoplasia), known gynecologic malignancy, and any contraindications to abdominal or vaginal morcellation
- No chronic pain disorders requiring medical management (endometriosis can be included)
Other
- Appendectomy for endometriosis is not excluded
- Planned abdominal hysterectomy or vaginal hysterectomy candidates
- Conversion to laparotomy or inability to complete morcellation
- Contraindications to laparoscopy
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.