The Effect of Intraoperative Contact Sonography on Quality of Life Following Laparoscopic or Robotic Myomectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change in Quality of Life
研究概览
简要总结
This study evaluates whether use of intraoperative ultrasound during laparoscopic or robotic myomectomy impacts quality of life. Half of participants will undergo laparoscopic or robotic myomectomy with use of the intraoperative ultrasound and half will undergo traditional laparoscopic or robotic myomectomy.
详细描述
In full acknowledgement of the correlation between complete leiomyoma exeresis and symptom relief, the investigators hypothesize that use of contact ultrasonography at the time of laparoscopic or robotic myomectomy will enable improved identification and extraction of uterine fibroids which will, in turn, lead to a greater improvement in quality of life among those women who receive intraoperative ultrasound compared to those who do not. In this blinded randomized controlled trial, the investigators will augment traditional laparoscopic and robotic myomectomy with intraoperative ultrasound in half the symptomatic patients enrolled in the study. The other half will be randomized to undergo laparoscopic or robotic myomectomy without use of intra-operative ultrasound. Both groups will complete Uterine Fibroid Symptom and Quality of Life (UFS- QOL) questionnaires before and after surgery (6 months post procedure) to determine whether use of laparoscopic contact ultrasonography has a positive impact on patients' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal and nonpregnant
- •Advised to undergo laparoscopic or robotic myomectomy by their provider
- •Documented imaging with transvaginal ultrasound or pelvic MRI within the past year, which accurately and within reason documents the location and number of leiomyomas present within the uterus
- •If deemed necessary by the provider, must have a pelvic MRI prior to surgery that states there are no concerning findings for malignancy
- •Must be eligible to undergo laparoscopic surgery and willing to present for clinic and imaging follow up during the 6 months following myomectomy
- •Must understand and voluntarily sign an informed consent form.
排除标准
- •Appearance of uterus concerning for malignancy on pelvic MRI
- •Current pregnancy
- •Any contraindication to laparoscopic or robotic surgery
- •Treatment with gonadotropin-releasing hormone (GnRH) analogs in the past 36 months
研究组 & 干预措施
Without Ultrasound
Laparoscopic or robotic myomectomy will be performed without aid of intraoperative contact ultrasonography
With Ultrasound
Laparoscopic or robotic myomectomy will be performed with aid of intraoperative contact ultrasonography
干预措施: Intraoperative contact ultrasonography (Procedure)
结局指标
主要结局
Change in Quality of Life
时间窗: Measured at baseline (before surgery) and 6 months post-surgery
Symptom and health-related quality of life will be measured by The Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire administered to all study participants before myomectomy and 6 months post-myomectomy.
次要结局
- Operating Time(Measured at surgery)
- Blood Loss(Measured at surgery)
- Weight of Excised Myomas(Measured at the time of Pathology evaluation.)
研究者
Katherine Smith
Clinical fellow
The Cleveland Clinic