Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy

Not Applicable

Completed

• Conditions: Fibroid Uterus; Abnormal Uterine Bleeding; Uterine Bleeding; Surgery
• Interventions: Procedure: Total Laparoscopic Hysterectomy

• Registration Number: NCT04434066
• Lead Sponsor: University of Texas Southwestern Medical Center

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 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.

Study Timeline

• Study Start: 2020-01-08
• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Primary Completion: 2022-07-19
• Status Verified: 2024-11
• Study Completion: 2024-11-05
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abdominal Morcellation	Total Laparoscopic Hysterectomy	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.
Vaginal Morcellation	Total Laparoscopic Hysterectomy	Vaginal morcellation will occur following completion of the hysterectomy. All steps and instruments have been standardized for vaginal morcellation.

Primary Outcome Measures

Name	Time	Method
Mean difference in total operating room time	intraoperative	Total operating room time is defined as skin incision to skin closure

Secondary Outcome Measures

Name	Time	Method
Mean difference from baseline in Body Image Scale Score to 6-weeks post-operatively	through study completion up to 6-weeks post-operatively	Body Image Scale will be collected at baseline, and 6-weeks post-operatively. Body Image Scale will be scored from 10 to 40 points maximum, with higher scores referring to being "very dissatisfied" with overall body image
Rates of Post-Operative Complications	through study completion up to 6-weeks post-operatively	Post-operative complications will be collected including: readmission to the hospital or emergency room, number of visits seen in the clinic, diagnoses of infection, bleeding, blood transfusions, surgery-related injuries, reoperations, and overall mortality
Mean difference from baseline in Pain Visual Analogue Scale to 6-weeks post-operatively	through study completion up to 6-weeks post-operatively	Pain Visual Analogue Scale will be collected at baseline, and 6-weeks post-operatively. VAS scale will be measured from 0 to 10mm, with higher scores referring to more pain experienced
Mean difference from baseline in Quality of Life Score to 6-weeks post-operatively	through study completion up to 6-weeks post-operatively	Quality of Life Scores will be collected at baseline, and 6-weeks post-operatively. The Quality of Life Score will be scored from 11 to 44, with higher scores referring to better quality of life
Morcellation Time	intraoperative	Defined as specimen bag introduction to specimen bag removal
Mean difference from baseline in Quality of Recovery Score to 2-weeks post-operatively	through study completion up to 6-weeks post-operatively	Quality of Recovery will be collected at baseline, 24-hours, and 2-weeks post-operatively. Quality of Recovery will be scored from 10 to 100, with higher scores referring to better quality of recovery
Mean difference in the dosages of morphine milligram equivalent (MME) for post-operative pain between abdominal and vaginal morcellation	after surgery to 2-weeks post-operatively	The type and dosages of various narcotics will be recorded between both groups following surgery until 2-weeks post-operatively

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States