NCT00910468CompletedNot Applicable
Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids
Ascher-Walsh, Charles, M.D.1 site in 1 country150 target enrollmentStarted: July 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Post-operative variables, including estimated blood loss, length of stay, days to a regular diet and febrile morbidity
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •uterus less than or equal to 20 weeks in size by office exam and no greater than three intramural fibroids on pre-operative MRI.
Exclusion Criteria
- •significant medical problems limiting their ability to undergo a prolonged laparoscopic procedure and could not have had previous uterine surgery.
Outcomes
Primary Outcomes
Post-operative variables, including estimated blood loss, length of stay, days to a regular diet and febrile morbidity
Time Frame: 1 day
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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