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

NCT ID: NCT00910468

Last Updated: 2009-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Fibroid Uterus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Robot Assisted Laparoscopic Myomectomy

Robot-assisted Laparoscopic myomectomy

Intervention Type PROCEDURE

Robot-assisted Laparoscopic myomectomy

Myomectomy via Laparotomy

No interventions assigned to this group

Interventions

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Robot-assisted Laparoscopic myomectomy

Robot-assisted Laparoscopic myomectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ascher-Walsh, Charles, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Mount Sinai School of Medicine

Principal Investigators

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Charles Ascher-Walsh, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mt Sinai School of Medicine, Dept Obstetrics and Gynecology

Locations

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Mount SInai School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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HSD08-00631

Identifier Type: -

Identifier Source: org_study_id