Clinical trial NCT05955651: Prospective Analysis to Detect Myometrial Cells in Peritoneal Washing in Patients Undergoing Minimally Invasive Hysterectomy Using Containment Bag at University of Texas Medical Branch
Official title: Prospective Analysis to Detect Myometrial Cells in Peritoneal Washing in Patients Undergoing Minimally Invasive Hysterectomy Using Containment Bag at University of Texas Medical Branch
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hysterectomy
Keywords: Hysterectomy
Pelvic washings
Myometrial cell spillage
Fibroids
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women needing minimally invasive hysterectomy for benign conditions, 18 years and older.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Detection of myometrial cell spillage in peritoneal washing
timeFrame: Pelvic washing samples will be sent the pathology lab to be examined within 2 days of the surgery.
Secondary outcomes:
measure: Timing of myometrial cell spillage during hysterectomy
timeFrame: Pelvic washing samples will be sent the pathology lab to be examined within 2 days of the surgery.
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical branch
state: Texas
Study officials:
References: