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

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

Study Overview

• Status: Completed
• Conditions: Hysterectomy
• Intervention / Treatment: Diagnostic test: Peritoneal washings

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).

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women needing minimally invasive hysterectomy for benign conditions, 18 years and older.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pelvic washings; Three Samples of peritoneal washings will be collected and send to pathology. looking for myometrial cell spillage at three designated points in surgery. 1st before hysterectomy, 2nd after hysterectomy, and 3rd after morcellation and extraction of the uterus out of the abdominal cavity.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): June 10, 2025
• Study Completion (Actual): June 10, 2025

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Hysterectomy; Fibroids; Pelvic washings; Myometrial cell spillage
• Other Study ID Numbers: 22-0269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No