Laparoscopic Hysterectomy With and Without Robotic Assistance and Adverse Outcomes

Project Title Laparoscopic Hysterectomy With and Without Robotic Assistance and Adverse Outcomes
Date Posted
Tuesday, June 21, 2016
Status
Complete
Deliverables
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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Medical Product
laparoscopic hysterectomy
Health Outcome
intraoperative complication
medical complication
surgical site complication
Population / Cohort
All individuals
Time Period
October 1, 2008 - May 31, 2013
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER