Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Laparoscopy will be performed in the standard multi-port technique. The specimen will be morcellated in the EcoSac400 ECO-T bag.

EcoSac 400 ECO-T

Charles Miller, MD

The purpose of this study is to determine the safety and efficacy of insufflated bags for electromechanical power morcellation during laparoscopic hysterectomy and myomectomy for tissue removal and to observe the integrity of the bags throughout and after insufflation and power morcellation.

The hypothesis is the bags will remain in tact without leakage from the bags during and after power morcellation using the described contained system, confirming the safety and efficacy of the systems.

Uterine leiomyoma (fibroids) are non-cancerous smooth muscle tumors that can cause heavy menstrual bleeding, pain, and pressure. Common surgical treatment modalities are hysterectomy (removal of the uterus) or myomectomy (removal of the fibroid). Minimally invasive surgical techniques (laparoscopy) are generally recommended due to improved recovery time, decrease infection risk, decreased bleeding risk and overall decreased morbidity and mortality risks.

In order to remove a large uterus or large fibroids laparoscopically, a power morcellator is often used to cut the specimen into smaller pieces that can be removed through small incisions. Due to the concern regarding spread of small amounts of tissue during power morcellation, many surgeons are advocating contained power morcellation, i.e. morcellation inside a specimen bag.

This study will be evaluating the efficacy of contained morcellation using a specific specimen bag. Morcellation will be performed in the designated bag. The bag will then be removed evaluated for any egg albumin leakage. If there is no leakage, it can be inferred that there is no tissue is spread during the contained morcellation process using this bag.

Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy

Safety and Efficacy of Contained Electromechanical Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy

Leakage of egg albumin from the EcoSac bags after isolated bag morcellation or apparent leakage of specimen from the EcoSac bags during isolated bag morcellation. After morcellation is complete, the bag will be removed from the patient and tested in a separate room. 100 milliliters of egg albumin combined with methylene blue will be placed into the bag and the bag will be insufflated. Visual inspection will be used to assess leakage from the bag with outcome measures of "yes" or "no."

Time (in minutes) from insertion of the bag to removal of the bag

Espiner Medical LTD

Charles Miller

Obstetrician Gynecologist Surgeon

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Hemorrhage

Pain

Pelvic Pain

Endometriosis

Uterine Hemorrhage

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Connective Tissue

Connective Tissue Diseases

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.

Participants will be randomized into either abdominal or vaginal morcellation at time of total laparoscopic hysterectomy

Total Laparoscopic Hysterectomy

Kimberly A Kho, MD

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.

Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy

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

Total operating room time is defined as skin incision to skin closure

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

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

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

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

Defined as specimen bag introduction to specimen bag removal

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

The type and dosages of various narcotics will be recorded between both groups following surgery until 2-weeks post-operatively

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy	NCT02777203	Leiomyoma	EcoSac 400 ECO-...	18 Years -	Advocate Health Care
Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy	NCT04434066	Abnormal Uterin... Uterine Bleedin... Fibroid Uterus Surgery	Total Laparosco...	18 Years - 50 Years	University of Texas Southwestern Medical Center
Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy	NCT02777203	Leiomyoma	EcoSac 400 ECO-...	18 Years -	Advocate Health Care

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