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The Incidence of Pelvic Hematoma Following Hysterectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ron Auslender, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01498315
First received: December 21, 2011
Last updated: May 15, 2014
Last verified: May 2014
  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 Carmel Medical Center:

Primary Outcome Measures:
  • Inspection by Ultraspund of hematona [ Time Frame: after hysterectomy ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
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: NCT01498315

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

No publications provided

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
Study First Received: December 21, 2011
Last Updated: May 15, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hematoma
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014