Clinical trial · Observational
Prospective Analysis to Detect Myometrial Cells in Peritoneal Washing in Patients Undergoing Minimally Invasive Hysterectomy Using Containment Bag at University of Texas Medical Branch
NCT05955651CI-TRIAL-00093103completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Aim of the study is to determine endometrial/myometrial spillage during total laparoscopic hysterectomy with manual morcellation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hysterectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peritoneal washings | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pelvic washings
- description
- 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.
- interventionNames
- Diagnostic Test: Peritoneal washings
Primary outcomes (1)
- measure
- Detection of myometrial cell spillage in peritoneal washing
- timeFrame
- Pelvic washing samples will be sent the pathology lab to be examined within 2 days of the surgery.
- description
- 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)
- measure
- Timing of myometrial cell spillage during hysterectomy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.