Prospective Analysis to Detect Myometrial Cells in Peritoneal Washing in Patients Undergoing Minimally Invasive Hysterectomy Using Containment Bag at University of Texas Medical Branch
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Detection of myometrial cell spillage in peritoneal washing
研究概览
简要总结
The Aim of the study is to determine endometrial/myometrial spillage during total laparoscopic hysterectomy with manual morcellation.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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/
- •Women 18 years and older
- •Subjects must be able to provide consents.
- •Normal endometrial biopsy.
- •Normal cervical cancer screening
排除标准
- •Known Gynecological malignancy.
- •Endometrial biopsy with endometrial intraepithelial hyperplasia.
- •History of exposure to pelvic radiation
- •Post-menopausal patients
- •Emergency hysterectomy
- •TDC patients
- •Patient less than 18 years old
结局指标
主要结局
Detection of myometrial cell spillage in peritoneal washing
时间窗: Pelvic washing samples will be sent the pathology lab to be examined within 2 days of the surgery.
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
次要结局
- Timing of myometrial cell spillage during hysterectomy(Pelvic washing samples will be sent the pathology lab to be examined within 2 days of the surgery.)