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

Launched by THE UNIVERSITY OF TEXAS MEDICAL BRANCH, GALVESTON · Jul 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well a special method called "containment bag" works during a minimally invasive surgery known as laparoscopic hysterectomy. The goal is to see if any cells from the uterus spill into the abdominal area during the procedure, which could potentially affect recovery or health outcomes. The study is open to women between 18 and 74 years old who are having surgery for conditions like fibroids or endometriosis and have a uterus larger than 10 cm.

If you or someone you know is considering participating, eligible individuals will undergo this surgery at the University of Texas Medical Branch between August 2023 and August 2024. Participants should be in good health, with normal tests for uterine and cervical cancer, and must be able to give consent. This trial aims to improve surgical techniques and patient safety, so it could be an important step for women undergoing similar surgeries in the future.

Gender

FEMALE

Eligibility criteria

• 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