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

This study has been completed.
Sponsor:
Information provided by:
Ascher-Walsh, Charles, M.D.
ClinicalTrials.gov Identifier:
NCT00910468
First received: May 28, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention
Fibroid Uterus
Procedure: Robot-assisted Laparoscopic myomectomy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ascher-Walsh, Charles, M.D.:

Primary Outcome Measures:
  • Post-operative variables, including estimated blood loss, length of stay, days to a regular diet and febrile morbidity [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: July 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Robot Assisted Laparoscopic Myomectomy Procedure: Robot-assisted Laparoscopic myomectomy
Robot-assisted Laparoscopic myomectomy
Myomectomy via Laparotomy

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women with fibroid uterus desiring surgical management

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910468

Locations
United States, New York
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
  More Information

No publications provided

Responsible Party: Char;es Ascher-Walsh, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00910468     History of Changes
Other Study ID Numbers: HSD08-00631
Study First Received: May 28, 2009
Last Updated: May 28, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on April 17, 2014