Prospective Analysis to Detect Myometrial Cells in Peritoneal Washing in Patients Undergoing Minimally Invasive Hysterectomy Using Containment Bag at University of Texas Medical Branch
MF
TN
Overseen ByTruong Nguyen, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: The University of Texas Medical Branch, Galveston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
The Aim of the study is to determine endometrial/myometrial spillage during total laparoscopic hysterectomy with manual morcellation.
Eligibility Criteria
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.
Subjects must be able to provide consents.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgery
Participants undergo minimally invasive hysterectomy with containment bag morcellation
1 day
1 visit (in-person)
Sample Collection
Three samples of peritoneal washings are collected at designated points during surgery
1 day
Follow-up
Participants are monitored for safety and effectiveness after surgery
4 weeks
Treatment Details
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Pelvic washingsExperimental Treatment1 Intervention
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.
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Who Is Running the Clinical Trial?
The University of Texas Medical Branch, Galveston
Lead Sponsor
Trials
263
Recruited
55,400+
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