Clinical trial NCT02879058: Intraoperative Ultrasound in Laparoscopic or Robotic Myomectomy Patients
Official title: The Effect of Intraoperative Contact Sonography on Quality of Life Following Laparoscopic or Robotic Myomectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fibroid Uterus
Quality of Life
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 140
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Quality of Life
timeFrame: Measured at baseline (before surgery) and 6 months post-surgery
Secondary outcomes:
measure: Operating Time
timeFrame: Measured at surgery
measure: Blood Loss
timeFrame: Measured at surgery
measure: Weight of Excised Myomas
timeFrame: Measured at the time of Pathology evaluation.
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: Stephen E Zimberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinic Florida
name: Katherine A Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
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