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Spots Global Cancer Trial Database for Intraoperative Ultrasound in Laparoscopic or Robotic Myomectomy Patients

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: 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 ID: NCT02879058

Study Description

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.

Keywords

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Cleveland Clinic Florida, Weston, Florida, United States

Contact Details

Name: Stephen E Zimberg, MD

Affiliation: Cleveland Clinic Florida

Role: PRINCIPAL_INVESTIGATOR

Name: Katherine A Smith, MD

Affiliation: Cleveland Clinic Florida

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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