Laparoscopic Hysterectomy With and Without Robotic Assistance and Adverse Outcomes

    Basic Details
    Date Posted
    Tuesday, June 21, 2016
    Status
    Complete
    Medical Product
    laparoscopic hysterectomy
    Health Outcome(s)
    intraoperative complication
    medical complication
    surgical site complication
    Description

    Modular program-based one-time assessment of laparoscopic hysterectomy with and without robotic assistance and several outcomes (intraoperative complications, surgical site complications, and medical complications). The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of October 1, 2008 to May 31, 2013. Modular programs are adaptable standardized programs. Results were generated using Modular Program 6; click here for more information. This report includes data from 18 Data Partners.
     
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    Additional Details
    FDA Center
    CDER
    Time Period
    October 1, 2008 - May 31, 2013
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)