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Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erin Duecy, University of Rochester
ClinicalTrials.gov Identifier:
NCT00757484
First received: September 19, 2008
Last updated: December 15, 2015
Last verified: May 2015
  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 University of Rochester:

Primary Outcome Measures:
  • Percentage of Participants Who Underwent Gynecologic Surgery [ Time Frame: January 2007 to January 2008 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    % women with asymptomatic hypotension

  • Percentage of Participants Undergoing Different Types of Anesthesia [ Time Frame: January 2007 to January 2008 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: September 19, 2008
Results First Received: May 27, 2015
Last Updated: December 15, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 27, 2016