Fibroid Uterus, Quality of Life
Conditions
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.
Interventions
PROCEDUREIntraoperative contact ultrasonography
In patients randomized to myomectomy with contact ultrasonography, the laparoscopic or robotic ultrasound probe will be advanced through an existing port site into the pelvis after traditional myomectomy has been performed. The face of the ultrasound transducer will be guided over the uterus (including open hysterotomy sites) in systematic strokes, taking special care to note locations of myomas that may have been missed by the preceding excision. Additional hysterotomy sites will be made as necessary in order to remove persistent myomas. Any number of additional ultrasound passes and excisions may be performed in order to achieve the most comprehensive removal of myomas.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating Time | Measured at surgery | Operating time is defined as the total period of time from when the procedure starts until the procedure is deemed complete. |
| Blood Loss | Measured at surgery | Blood loss (in mL) will be estimated for all procedures by the primary surgeon and gleaned from the anesthesia operative flowsheet. |
| Weight of Excised Myomas | Measured at the time of Pathology evaluation. | After extraction, all myomas will be submitted to pathology. Their cumulative weight will be measured by the Pathologist and gleaned by the research team from the final pathology report. |
Countries
United States
Outcome results
None listed