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NCT00910468 Clinical Trial

Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids

Fibroid Uterus Clinical Trial

Official title:
Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00910468
Other study ID # HSD08-00631
Secondary ID
Status Completed
Phase N/A
First received May 28, 2009
Last updated May 28, 2009
Start date July 2005
Est. completion date July 2008

Study information
Verified date May 2009
Source Ascher-Walsh, Charles, M.D.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Robot-assisted Laparoscopic myomectomy
Robot-assisted Laparoscopic myomectomy

Locations
Country Name City State
United States Mount SInai School of Medicine New York New York

Sponsors (1)
Lead Sponsor Collaborator
Ascher-Walsh, Charles, M.D.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post-operative variables, including estimated blood loss, length of stay, days to a regular diet and febrile morbidity 1 day No
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