Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy

November 5, 2024 updated by: Kimberly Kho, University of Texas Southwestern Medical Center

A Comparison of Perioperative and Patient-Centered Outcomes with Abdominal Versus Vaginal Morcellation: a Randomized-Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75229
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abdominal Morcellation
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.
Procedure: Total Laparoscopic Hysterectomy
Participants will be randomized into either abdominal or vaginal morcellation at time of total laparoscopic hysterectomy
Experimental: Vaginal Morcellation
Vaginal morcellation will occur following completion of the hysterectomy. All steps and instruments have been standardized for vaginal morcellation.
Procedure: Total Laparoscopic Hysterectomy
Participants will be randomized into either abdominal or vaginal morcellation at time of total laparoscopic hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference in total operating room time
Time Frame: intraoperative
Total operating room time is defined as skin incision to skin closure
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference from baseline in Body Image Scale Score to 6-weeks post-operatively
Time Frame: 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
through study completion up to 6-weeks post-operatively
Mean difference from baseline in Pain Visual Analogue Scale to 6-weeks post-operatively
Time Frame: 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
through study completion up to 6-weeks post-operatively
Mean difference from baseline in Quality of Recovery Score to 2-weeks post-operatively
Time Frame: 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
through study completion up to 6-weeks post-operatively
Mean difference from baseline in Quality of Life Score to 6-weeks post-operatively
Time Frame: 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
through study completion up to 6-weeks post-operatively
Morcellation Time
Time Frame: intraoperative
Defined as specimen bag introduction to specimen bag removal
intraoperative
Rates of Post-Operative Complications
Time Frame: 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
through study completion up to 6-weeks post-operatively
Mean difference in the dosages of morphine milligram equivalent (MME) for post-operative pain between abdominal and vaginal morcellation
Time Frame: 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
after surgery to 2-weeks post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Kimberly A Kho, MD, UT Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2020

Primary Completion (Actual)

July 19, 2022

Study Completion (Actual)

November 5, 2024

Study Registration Dates

First Submitted

June 12, 2020

First Submitted That Met QC Criteria

June 12, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2019-1402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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