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

NCT05955651 | Completed

• 1 other identifier: 22-0269
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hysterectomy

Keywords

Hysterectomy; Pelvic washings; Myometrial cell spillage; Fibroids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

Peritoneal washings DIAGNOSTIC_TEST

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.

Pelvic washings

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Women undergoing minimally invasive Laparoscopic / Robotic hysterectomy for presumably benign conditions such as (fibroids, adenomyosis, endometriosis, pelvic organ prolapse, abnormal uterine bleeding)
• 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.
• Women 18 years and older
• Subjects must be able to provide consents.
• Normal endometrial biopsy.
• Normal cervical cancer screening

You may not qualify if:

• Known Gynecological malignancy.
• Endometrial biopsy with endometrial intraepithelial hyperplasia.
• History of exposure to pelvic radiation
• Post-menopausal patients
• Emergency hysterectomy
• TDC patients
• Patient less than 18 years old

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: August 1, 2023
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)