NCT02879058

Intraoperative Ultrasound in Laparoscopic or Robotic Myomectomy Patients

The Effect of Intraoperative Contact Sonography on Quality of Life Following Laparoscopic or Robotic Myomectomy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fibroid Uterus
• Quality of Life

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-08-25
• Last updated: 2019-03-04

Locations

1 site across 1 country: United States