NCT04434066

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Abnormal Uterine Bleeding
• Uterine Bleeding
• Fibroid Uterus
• Surgery

Interventions

Type	Name	Description
PROCEDURE	Total Laparoscopic Hysterectomy	Participants will be randomized into either abdominal or vaginal morcellation at time of total laparoscopic hysterectomy

Timeline

• Start date: 2020-01-08
• Primary completion: 2022-07-19
• Completion: 2024-11-05
• First posted: 2020-06-16
• Last updated: 2024-11-08

Locations

1 site across 1 country: United States