Intraoperative Ultrasound in Laparoscopic or Robotic Myomectomy Patients

NeuroTherapia, Inc.

Status: Terminated

Conditions: Fibroid Uterus; Quality of Life

Treatments: Procedure: Intraoperative contact ultrasonography

Study type: Interventional

Funder types: Other

Identifiers

NCT02879058

FLA- 16-031

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Premenopausal and nonpregnant
2. Advised to undergo laparoscopic or robotic myomectomy by their provider
3. 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
4. If deemed necessary by the provider, must have a pelvic MRI prior to surgery that states there are no concerning findings for malignancy
5. Must be eligible to undergo laparoscopic surgery and willing to present for clinic and imaging follow up during the 6 months following myomectomy
6. Must understand and voluntarily sign an informed consent form.

Exclusion criteria

1. Appearance of uterus concerning for malignancy on pelvic MRI
2. Current pregnancy
3. Any contraindication to laparoscopic or robotic surgery
4. Treatment with gonadotropin-releasing hormone (GnRH) analogs in the past 36 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Without Ultrasound

No Intervention group

Description:

Laparoscopic or robotic myomectomy will be performed without aid of intraoperative contact ultrasonography

With Ultrasound

Experimental group

Description:

Laparoscopic or robotic myomectomy will be performed with aid of intraoperative contact ultrasonography

Treatment:

Procedure: Intraoperative contact ultrasonography