Hysterectomy
Conditions
Keywords
Hysterectomy, Pelvic washings, Myometrial cell spillage, Fibroids
Brief summary
The Aim of the study is to determine endometrial/myometrial spillage during total laparoscopic hysterectomy with manual morcellation.
Detailed description
This will be a single institution prospective analysis study. The study will include 50 women who are undergoing minimally invasive hysterectomy. Surgery will be done from 08/01/2023 to 08/01/2024, for benign conditions with uterus that is \> 10 cm that requires contained bag morcellation such as (Fibroids, Adenomyosis, Endometriosis, abnormal uterine bleeding, pelvic organ prolapse). Three Samples of peritoneal washings will be collected and send to pathology. First washing will be collected after entering the abdominal cavity, second washing will be done after completion of hysterectomy and containment of the uterus in the bag, and the third washing after scalpel morcellation of the uterus in the containment bag and extraction within the bag. Extraction of the specimen will be done either through the vagina or through a mini laparotomy incision (2-3 cm).
Interventions
DIAGNOSTIC_TESTPeritoneal washings
Peritoneal washing will be done at designated point in the surgical procedure. one hundred cc of normal saline, will be used to irrigate the peritoneal cavity. Samples of the fluid will be collected, with the goal to collect as much fluid as possible for the study, with minimum of 60 cc should be collected. Samples will be sent to the pathology lab. 1. First washing will be collected after obtaining entry into the peritoneal cavity with placement of the first laparoscopic trocar, before any manipulation of the uterus. 2. Second washing will be done after the hysterectomy and containment of the uterus in the bag. 3. Third washing will be collected after scalpel morcellation of the uterus in the containment bag, extraction and closure of the vaginal cuff.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women undergoing minimally invasive Laparoscopic / Robotic hysterectomy for presumably benign conditions such as (fibroids, adenomyosis, endometriosis, pelvic organ prolapse, abnormal uterine bleeding) 2. Large size uterus measuring more than 10 cm on US requiring cold knife morcellation within the Alexis containment bag, surgery will be done by designated surgeon at UTMB from 08/01/2023 to 08/01/2024. 3. Women 18 years and older 4. Subjects must be able to provide consents. 5. Normal endometrial biopsy. 6. Normal cervical cancer screening
Exclusion criteria
1. Known Gynecological malignancy. 2. Endometrial biopsy with endometrial intraepithelial hyperplasia. 3. History of exposure to pelvic radiation 4. Post-menopausal patients 5. Emergency hysterectomy 6. TDC patients 7. Patient less than 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of myometrial cell spillage in peritoneal washing | Pelvic washing samples will be sent the pathology lab to be examined within 2 days of the surgery. | To evaluate potential cell spillage from morcellated tissue, the 3 peritoneal washings collected will be sent to cytology lab to be examined for the presence of smooth muscle cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timing of myometrial cell spillage during hysterectomy | Pelvic washing samples will be sent the pathology lab to be examined within 2 days of the surgery. | To determine at what stage myometrial cell spillage happens during a minimally invasive hysterectomy surgery (before, after completion of the hysterectomy or after morcellation and tissue extraction) |
Countries
United States
Outcome results
None listed