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

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ClinicalTrials.gov Identifier: NCT00910468
Recruitment Status : Completed
First Posted : May 29, 2009
Last Update Posted : May 29, 2009
Sponsor:
Information provided by:
Ascher-Walsh, Charles, M.D.

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
Fibroid Uterus Procedure: Robot-assisted Laparoscopic myomectomy

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 : July 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids
U.S. FDA Resources

Group/Cohort Intervention/treatment
Robot Assisted Laparoscopic Myomectomy Procedure: Robot-assisted Laparoscopic myomectomy
Robot-assisted Laparoscopic myomectomy
Myomectomy via Laparotomy



Primary Outcome Measures :
  1. Post-operative variables, including estimated blood loss, length of stay, days to a regular diet and febrile morbidity [ Time Frame: 1 day ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Char;es Ascher-Walsh, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00910468     History of Changes
Other Study ID Numbers: HSD08-00631
First Posted: May 29, 2009    Key Record Dates
Last Update Posted: May 29, 2009
Last Verified: May 2009

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