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Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy

Primary Purpose

Abnormal Uterine Bleeding, Uterine Bleeding, Fibroid Uterus

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Laparoscopic Hysterectomy
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abnormal Uterine Bleeding focused on measuring hysterectomy, abnormal uterine bleeding, morcellation, abdominal, vaginal, surgery, laparoscopic, laparoscopy, total hysterectomy, pelvic pain, endometriosis

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts 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

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Abdominal Morcellation

Vaginal Morcellation

Arm 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.

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

Outcomes

Primary Outcome Measures

Mean difference in total operating room time
Total operating room time is defined as skin incision to skin closure

Secondary Outcome Measures

Mean difference from baseline in Body Image Scale Score 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
Mean difference from baseline in Pain Visual Analogue Scale 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 Recovery Score to 2-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 from baseline in Quality of Life Score 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
Defined as specimen bag introduction to specimen bag removal
Rates of Post-Operative Complications
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 in the dosages of morphine milligram equivalent (MME) for post-operative pain between abdominal and vaginal morcellation
The type and dosages of various narcotics will be recorded between both groups following surgery until 2-weeks post-operatively

Full Information

First Posted
June 12, 2020
Last Updated
September 29, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04434066
Brief Title
Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy
Official Title
A Comparison of Perioperative and Patient-Centered Outcomes With Abdominal Versus Vaginal Morcellation: A Randomized-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
July 19, 2022 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: To evaluate differences in total operating time between subjects undergoing AM compared to VM. To evaluate differences in morcellation time between AM and VM. To evaluate differences in the amount of total narcotic use during hospital admission between AM and VM through morphine milligram equivalents (MME). 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. 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. To evaluate differences in body image survey (BIS) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Uterine Bleeding, Uterine Bleeding, Fibroid Uterus, Surgery
Keywords
hysterectomy, abnormal uterine bleeding, morcellation, abdominal, vaginal, surgery, laparoscopic, laparoscopy, total hysterectomy, pelvic pain, endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abdominal Morcellation
Arm Type
Experimental
Arm 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.
Arm Title
Vaginal Morcellation
Arm Type
Experimental
Arm Description
Vaginal morcellation will occur following completion of the hysterectomy. All steps and instruments have been standardized for vaginal morcellation.
Intervention Type
Procedure
Intervention Name(s)
Total Laparoscopic Hysterectomy
Intervention Description
Participants will be randomized into either abdominal or vaginal morcellation at time of total laparoscopic hysterectomy
Primary Outcome Measure Information:
Title
Mean difference in total operating room time
Description
Total operating room time is defined as skin incision to skin closure
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Mean difference from baseline in Body Image Scale Score to 6-weeks post-operatively
Description
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
Time Frame
through study completion up to 6-weeks post-operatively
Title
Mean difference from baseline in Pain Visual Analogue Scale to 6-weeks post-operatively
Description
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
Time Frame
through study completion up to 6-weeks post-operatively
Title
Mean difference from baseline in Quality of Recovery Score to 2-weeks post-operatively
Description
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
Time Frame
through study completion up to 6-weeks post-operatively
Title
Mean difference from baseline in Quality of Life Score to 6-weeks post-operatively
Description
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
Time Frame
through study completion up to 6-weeks post-operatively
Title
Morcellation Time
Description
Defined as specimen bag introduction to specimen bag removal
Time Frame
intraoperative
Title
Rates of Post-Operative Complications
Description
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
Time Frame
through study completion up to 6-weeks post-operatively
Title
Mean difference in the dosages of morphine milligram equivalent (MME) for post-operative pain between abdominal and vaginal morcellation
Description
The type and dosages of various narcotics will be recorded between both groups following surgery until 2-weeks post-operatively
Time Frame
after surgery to 2-weeks post-operatively

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly A Kho, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
US Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)
Results Reference
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US Food and Drug Administration. Updated Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)
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Results Reference
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Cohen SL, Einarsson JI, Wang KC, Brown D, Boruta D, Scheib SA, Fader AN, Shibley T. Contained power morcellation within an insufflated isolation bag. Obstet Gynecol. 2014 Sep;124(3):491-497. doi: 10.1097/AOG.0000000000000421.
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Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy

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