The Incidence of Pelvic Hematoma Following Hysterectomy

NCT ID: NCT01498315

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-05-31

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.

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.

Conditions

Hematoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Women following hysterecomy

Ultrasound examination

Intervention Type: OTHER

Ultrasound examination following hysterectomy

Interventions

Ultrasound examination

Ultrasound examination following hysterectomy

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

• not relevant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ron Auslender

Head of Obstetric and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ron Auslender, Dr

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Other Identifiers

CMC-11-0073-CTIL

Identifier Type: -

Identifier Source: org_study_id