Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparison of Perioperative and Patient-Centered Outcomes With Abdominal Versus Vaginal Morcellation: A Randomized-Controlled Trial

Conditions
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Abnormal Uterine Bleeding, Uterine Bleeding, Fibroid Uterus, Surgery

Intervention / Treatment
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* Procedure: Total Laparoscopic Hysterectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in total operating room time | 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 | 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 | 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 | 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 | 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 | Defined as specimen bag introduction to specimen bag removal | 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 | 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 | after surgery to 2-weeks post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysterectomy, abnormal uterine bleeding, morcellation, abdominal, vaginal, surgery, laparoscopic, laparoscopy, total hysterectomy, pelvic pain, endometriosis