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

Recruiting

• Conditions: Hysterectomy
• Interventions: Diagnostic Test: Peritoneal washings

• Registration Number: NCT05955651
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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).

Study Timeline

• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-21
• Study Start: 2023-08-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-07-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pelvic washings	Peritoneal 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Texas Medical branch; 🇺🇸 Galveston, Texas, United States