Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy

The University of Texas System (UT)

Status: Completed

Conditions: Uterine Bleeding; Fibroid Uterus; Surgery; Abnormal Uterine Bleeding

Treatments: Procedure: Total Laparoscopic Hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04434066

STU-2019-1402

Details and patient eligibility

About

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.

Full 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 undergoing laparoscopic total hysterectomies in a randomized surgical trial.

Objectives:

1. To evaluate differences in total operating time between subjects undergoing AM compared to VM.
2. To evaluate differences in morcellation time between AM and VM.
3. To evaluate differences in the amount of total narcotic use during hospital admission between AM and VM through morphine milligram equivalents (MME).
4. To evaluate differences in the patient's subjective pain assessment via Visual Analogue Scale (VAS) before surgery, at 2-weeks, and at 6 week post-operative visits in both AM and VM groups.
5. To evaluate differences in the patient's pain medication usage as reported by the patient verbally at 24-hours post-operatively and 2-weeks post surgery between AM and VM groups.
6. To evaluate differences in body image survey (BIS) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
7. To evaluate differences in overall Quality of Life (QoL) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
8. To evaluate differences in Quality of Recovery (QoR) scores at enrollment and at 24-hours post-operatively, and then 2-weeks post surgery between AM and VM group.

Enrollment: 46 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Abdominal Morcellation

Experimental group

Description:

Abdominal morcellation will occur following completion of the hysterectomy. Route of incision will be either suprapubic or umbilical incision - based on surgeon preferences. All steps and instruments have been standardized for abdominal morcellation.

Treatment:

Procedure: Total Laparoscopic Hysterectomy

Vaginal Morcellation

Experimental group

Description:

Vaginal morcellation will occur following completion of the hysterectomy. All steps and instruments have been standardized for vaginal morcellation.

Treatment:

Procedure: Total Laparoscopic Hysterectomy