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The Incidence of Pelvic Hematoma Following Hysterectomy (Hematoma)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01498315
First Posted: December 23, 2011
Last Update Posted: May 16, 2014
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):
Ron Auslender, Carmel Medical Center
  Purpose
Hysterectomy is one of the common operations in gynecology. With population aging in modern society, the incidence of these surgeries is expected to increase even more. One of the major complications of pelvic surgery is symptomatic pelvic hematoma, which can present with pain, fever, and foul smelling discharge. The incidence of pelvic hematoma is 40%, and varies according to the type of hysterectomy and the diagnostic procedure. Those hematoma increase the risk for infection. Diagnosis usually is not a clinical one unless symptoms occur, and then the diagnosis is made by CT or ultrasound. Number of interventions are mentioned in the literature to try and decrease post operative complications and infections, none have suggested effective enough. This is a prospective study which objective is to characterize the incidence of pelvic hematoma following hysterectomy using ultrasound. The investigators will also try to identify preoperative, intraoperative and postoperative risk factors for infection of this hematomas. This identification might decrease the incidence of postoperative hematoma and infection.

Condition Intervention
Hematoma Other: Ultrasound examination

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Incidence of Pelvic Hematoma Following Hysterectomy

Resource links provided by NLM:


Further study details as provided by Ron Auslender, Carmel Medical Center:

Primary Outcome Measures:
  • Inspection by Ultraspund of hematona [ Time Frame: after hysterectomy ]
    Inspection by Ultraspund of hematona


Enrollment: 39
Study Start Date: March 2012
Study Completion Date: May 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women following hysterecomy Other: Ultrasound examination
Ultrasound examination following hysterectomy

Detailed Description:
aging in modern society, the incidence of these surgeries is expected to increase even more. One of the major complications of pelvic surgery is symptomatic pelvic hematoma, which can present with pain, fever, and foul smelling discharge. The incidence of pelvic hematoma is 40%, and varies according to the type of hysterectomy and the diagnostic procedure. Those hematoma increase the risk for infection. Diagnosis usually is not a clinical one unless symptoms occur, and then the diagnosis is made by CT or ultrasound. Number of interventions are mentioned in the literature to try and decrease post operative complications and infections, none have suggested effective enough. This is a prospective study which objective is to characterize the incidence of pelvic hematoma following hysterectomy using ultrasound. The investigators will also try to identify preoperative, intraoperative and postoperative risk factors for infection of this hematomas. This identification might decrease the incidence of postoperative hematoma and infection.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women following hysterectomy
Criteria

Inclusion Criteria:Women following Hysterectomy in the gynecologic division Carmel Medical Center

Exclusion Criteria:

  • not relevant
  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): NCT01498315


Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Ron Auslender, Dr Carmel Medical Center
  More Information

Responsible Party: Ron Auslender, Head of Obstetric and Gynecology, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01498315     History of Changes
Other Study ID Numbers: CMC-11-0073-CTIL
First Submitted: December 21, 2011
First Posted: December 23, 2011
Last Update Posted: May 16, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Hematoma
Hemorrhage
Pathologic Processes