Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00757484
Recruitment Status : Completed
First Posted : September 23, 2008
Results First Posted : December 17, 2015
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
Erin Duecy, University of Rochester

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to establish normal postoperative changes in blood pressure in women undergoing scheduled gynecologic surgery requiring inpatient postoperative care. Also, to establish if there is a difference in normal postoperative blood pressure changes between elderly and non-elderly women undergoing scheduled gynecologic surgery requiring inpatient postoperative care.

Condition or disease
Urogynecology

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 528 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery
Study Start Date : September 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of Participants Who Underwent Gynecologic Surgery [ Time Frame: January 2007 to January 2008 ]
    491 women were included in analysis. Measure is categorized by the type of surgery.


Secondary Outcome Measures :
  1. Percentage of Women With Asymptomatic Hypotension [ Time Frame: 1 year ]
    % women with asymptomatic hypotension

  2. Percentage of Participants Undergoing Different Types of Anesthesia [ Time Frame: January 2007 to January 2008 ]
    Patients were given either general, regional or local-modified anesthesia care (LO-MAC). Some of the patients ended up getting both general and regional anesthesia (sometimes anesthesia team decides to add regional for postop pain control).

  3. Surgical Time [ Time Frame: January 2007 to January 2008 ]
    Length of surgery


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Gynecologic patients
Criteria

Inclusion Criteria:

  • Women who underwent scheduled gynecologic surgery requiring inpatient postoperative care between January 2007 - January 2008

Exclusion Criteria:

  • Women who experienced myocardial infarction, cardiac arrest or failure, pulmonary embolism, infection requiring intravenous antibiotics, intra- or postoperative hemorrhage requiring blood transfusion, renal failure
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00757484


Locations
Layout table for location information
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Layout table for investigator information
Principal Investigator: Erin Duecy, MD University of Rochester
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Erin Duecy, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00757484    
Other Study ID Numbers: 25003
First Posted: September 23, 2008    Key Record Dates
Results First Posted: December 17, 2015
Last Update Posted: December 17, 2015
Last Verified: May 2015