The Incidence of Pelvic Hematoma Following Hysterectomy (Hematoma)

May 15, 2014 updated by: Ron Auslender, Carmel Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

39

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women following hysterectomy

Description

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

Exclusion Criteria:

  • not relevant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inspection by Ultraspund of hematona
Time Frame: after hysterectomy
Inspection by Ultraspund of hematona
after hysterectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Investigators

  • Principal Investigator: Ron Auslender, Dr, Carmel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

December 21, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimate)

December 23, 2011

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 15, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-11-0073-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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