Prospective Analysis to Detect Myometrial Cells in Peritoneal Washing in Patients Undergoing Minimally Invasive Hysterectomy Using Containment Bag at University of Texas Medical Branch

Hysterectomy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05955651
• Other study ID #: 22-0269
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: August 1, 2028

Study information

• Verified date: August 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: Mostafa F Eyada, MD
• Phone: 409-747-4952
• Email: mfeyada[@]utmb.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Aim of the study is to determine endometrial/myometrial spillage during total laparoscopic hysterectomy with manual morcellation.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2028
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Diagnostic Test:
• Peritoneal 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. 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. Second washing will be done after the hysterectomy and containment of the uterus in the bag. Third washing will be collected after scalpel morcellation of the uterus in the containment bag, extraction and closure of the vaginal cuff.

Locations

Country	Name	City	State
United States	University of Texas Medical branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of myometrial cell spillage in peritoneal washing	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	Pelvic washing samples will be sent the pathology lab to be examined within 2 days of the surgery.
Secondary	Timing of myometrial cell spillage during hysterectomy	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)	Pelvic washing samples will be sent the pathology lab to be examined within 2 days of the surgery.