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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Participants will be randomized into either abdominal or vaginal morcellation at time of total laparoscopic hysterectomy
UT Southwestern Medical Center
Dallas, Texas, United States
Mean difference in total operating room time
Total operating room time is defined as skin incision to skin closure
Time frame: intraoperative
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
Time frame: through study completion up to 6-weeks post-operatively
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
Time frame: through study completion up to 6-weeks post-operatively
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
Time frame: through study completion up to 6-weeks post-operatively
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
Time frame: through study completion up to 6-weeks post-operatively
Morcellation Time
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Defined as specimen bag introduction to specimen bag removal
Time frame: intraoperative
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
Time frame: 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
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