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OpenTrials
Completed

NCT Number: NCT05955651

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Texas Medical branch

Galveston, Texas, 77555, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

  • 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.

Primary outcomes

  1. Detection of myometrial cell spillage in peritoneal washing

    Time frame: 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 outcomes

  1. Timing of myometrial cell spillage during hysterectomy

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 21, 2023
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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