Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids
Sponsor
Ascher-Walsh, Charles, M.D. (Other)
Overall Status
Completed
CT.gov ID
NCT00910468
Collaborator
(none)
150
1
36
4.2
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
150 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids
Study Start Date
:
Jul 1, 2005
Actual Primary Completion Date
:
Jul 1, 2008
Actual Study Completion Date
:
Jul 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Robot Assisted Laparoscopic Myomectomy
|
Procedure: Robot-assisted Laparoscopic myomectomy
Robot-assisted Laparoscopic myomectomy
|
| Myomectomy via Laparotomy
|
Outcome Measures
Primary Outcome Measures
- Post-operative variables, including estimated blood loss, length of stay, days to a regular diet and febrile morbidity [1 day]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mount SInai School of Medicine | New York | New York | United States | 10029 |
Sponsors and Collaborators
- Ascher-Walsh, Charles, M.D.
Investigators
- Principal Investigator: Charles Ascher-Walsh, MD, MPH, Mt Sinai School of Medicine, Dept Obstetrics and Gynecology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00910468
Other Study ID Numbers:
- HSD08-00631
First Posted:
May 29, 2009
Last Update Posted:
May 29, 2009
Last Verified:
May 1, 2009