The Incidence of Pelvic Hematoma Following Hysterectomy
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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 |
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 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 |
Women following hysterectomy
Inclusion Criteria:Women following Hysterectomy in the gynecologic division Carmel Medical Center
Exclusion Criteria:
- not relevant
Contacts and Locations| Contact: Ron Auslender, Dr | 972-4-8250637 | ronmd@clalit.org.il |
| Contact: yakir segev, Dr | 972-4-8250637 | yakirse@clalit.org.il |
| 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: | 0073-11-CMC |
| Study First Received: | December 21, 2011 |
| Last Updated: | December 25, 2011 |
| Health Authority: | Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Hematoma Hemorrhage Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013