Intraoperative Ultrasound in Laparoscopic or Robotic Myomectomy Patients

Stopped early · Not applicable

Conditions studied: Fibroid Uterus, Quality of Life

In brief

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.

Key facts

Study ID

NCT02879058

Run by

The Cleveland Clinic

People needed

140

Starts

2016-06-01

Expected to finish

2018-12-01

Last updated by the study team

2019-03-04

Who can join

Age: 21 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic Florida — Weston, Florida, United States

Full record on ClinicalTrials.gov

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