Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids
1 other identifier
observational
150
1 country
1
Brief Summary
This is a retrospective, case-control study of 75 patients having undergone a robotic-assisted laparoscopic myomectomy were compared to patients having undergone myomectomy via laparotomy. Both groups had 3 or fewer fibroids confirmed by pre-operative MRI or on final pathology report. Charts were reviewed for surgical and post-operative variables
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2005
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 28, 2009
CompletedFirst Posted
Study publicly available on registry
May 29, 2009
CompletedMay 29, 2009
May 1, 2009
3 years
May 28, 2009
May 28, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative variables, including estimated blood loss, length of stay, days to a regular diet and febrile morbidity
1 day
Study Arms (2)
Robot Assisted Laparoscopic Myomectomy
Myomectomy via Laparotomy
Interventions
Robot-assisted Laparoscopic myomectomy
Eligibility Criteria
Women with fibroid uterus desiring surgical management
You may qualify if:
- uterus less than or equal to 20 weeks in size by office exam and no greater than three intramural fibroids on pre-operative MRI.
You may not qualify if:
- significant medical problems limiting their ability to undergo a prolonged laparoscopic procedure and could not have had previous uterine surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount SInai School of Medicine
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Ascher-Walsh, MD, MPH
Mt Sinai School of Medicine, Dept Obstetrics and Gynecology
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDIV
Study Record Dates
First Submitted
May 28, 2009
First Posted
May 29, 2009
Study Start
July 1, 2005
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
May 29, 2009
Record last verified: 2009-05