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Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00757484
First Posted: September 23, 2008
Last Update Posted: December 17, 2015
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.
Information provided by (Responsible Party):
Erin Duecy, University of Rochester
  Purpose
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
Urogynecology

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery

Further study details as provided by Erin Duecy, University of Rochester:

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

  • 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).

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


Enrollment: 528
Study Start Date: September 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Erin Duecy, MD University of Rochester
  More Information

Responsible Party: Erin Duecy, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00757484     History of Changes
Other Study ID Numbers: 25003
First Submitted: September 19, 2008
First Posted: September 23, 2008
Results First Submitted: May 27, 2015
Results First Posted: December 17, 2015
Last Update Posted: December 17, 2015
Last Verified: May 2015