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The Incidence of Pelvic Hematoma Following Hysterectomy (Hematoma)

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ClinicalTrials.gov Identifier: NCT01498315
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Ron Auslender, Carmel Medical Center

Brief Summary:
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 or disease Intervention/treatment
Hematoma Other: Ultrasound examination

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.

Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Incidence of Pelvic Hematoma Following Hysterectomy
Study Start Date : March 2012
Primary Completion Date : November 2013
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Group/Cohort Intervention/treatment
Women following hysterecomy Other: Ultrasound examination
Ultrasound examination following hysterectomy



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



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

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

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 Posted: December 23, 2011    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Hematoma
Hemorrhage
Pathologic Processes