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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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
    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.

Recruiting Locations

University of Texas Medical branch
Galveston, Texas 77555
Contact:
Mostafa F Eyada, MD
409-747-4952
mfeyada@utmb.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Mostafa F Eyada, MD
409-747-4952
mfeyada@utmb.edu

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.