Analyzing Myometrial Cell Spillage During Minimally Invasive Hysterectomy
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 University of Texas Medical Branch, Galveston · NCT05955651
This study is trying to see if there is any spillage of uterine cells during a minimally invasive surgery for women with large uteri.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The University of Texas Medical Branch, Galveston (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT05955651 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the spillage of endometrial and myometrial cells during total laparoscopic hysterectomy with manual morcellation in women with large uteri. It will involve 50 participants undergoing minimally invasive hysterectomy for benign conditions, with surgeries conducted between August 2023 and August 2024. Three samples of peritoneal washings will be collected at different stages of the procedure to evaluate cell spillage and sent for pathological analysis. The study is being conducted at the University of Texas Medical Branch.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older undergoing minimally invasive hysterectomy for benign conditions with a uterus larger than 10 cm.
Not a fit: Patients with known gynecological malignancies or those requiring emergency hysterectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical techniques and reduce the risk of cell spillage during hysterectomy procedures.
How similar studies have performed: While similar studies have explored cell spillage during hysterectomy, this specific approach using containment bags is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Galveston, Texas
- University of Texas Medical branch — Galveston, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Mostafa F Eyada, MD
- Email: mfeyada@utmb.edu
- Phone: 409-747-4952
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hysterectomy, Pelvic washings, Myometrial cell spillage, Fibroids