An interventional study of Intraoperative contact ultrasonography in Fibroid Uterus and Quality of Life, sponsored by The Cleveland Clinic. Terminated at 1 site in United States. Open to female participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-04.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
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.
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's planned enrollment of 140 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
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Exclusion Criteria:
Laparoscopic or robotic myomectomy will be performed without aid of intraoperative contact ultrasonography
Laparoscopic or robotic myomectomy will be performed with aid of intraoperative contact ultrasonography
Procedure: Intraoperative 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.
Change in Quality of Life
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.
Time frame: Measured at baseline (before surgery) and 6 months post-surgery
Operating Time
Operating time is defined as the total period of time from when the procedure starts until the procedure is deemed complete.
Time frame: Measured at surgery
Blood Loss
Blood loss (in mL) will be estimated for all procedures by the primary surgeon and gleaned from the anesthesia operative flowsheet.
Time frame: Measured at surgery
Weight of Excised Myomas
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.
Time frame: Measured at the time of Pathology evaluation.
Plan to share: Yes — Selected de-identified ultrasound images and surgical data will be shared with BK Ultrasound, the manufacturer of the ultrasound device.
This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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