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

Last updated: December 6, 2024
Sponsor: The University of Texas Medical Branch, Galveston
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Peritoneal washings

Clinical Study ID

NCT05955651
22-0269
  • Ages > 18
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Women undergoing minimally invasive Laparoscopic / Robotic hysterectomy forpresumably benign conditions such as (fibroids, adenomyosis, endometriosis, pelvicorgan prolapse, abnormal uterine bleeding)

  2. Large size uterus measuring more than 10 cm on US requiring cold knife morcellationwithin the Alexis containment bag, surgery will be done by designated surgeon atUTMB 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

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

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Peritoneal washings
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
August 01, 2028

Study 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).

Connect with a study center

  • University of Texas Medical branch

    Galveston, Texas 77555
    United States

    Active - Recruiting

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