The Incidence of Pelvic Hematoma Following Hysterectomy

NCT01498315 | Completed

• 1 other identifier: CMC-11-0073-CTIL
• Study Type: observational
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hematoma

Outcome Measures

Primary Outcomes (1)

• Inspection by Ultraspund of hematona

  Inspection by Ultraspund of hematona

  after hysterectomy

Study Arms (1)

Women following hysterecomy

Other: Ultrasound examination

Interventions

Ultrasound examination OTHER

Ultrasound examination following hysterectomy

Women following hysterecomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women following hysterectomy

You may not qualify if:

• not relevant

Sponsors & Collaborators

• Carmel Medical Center: lead

MeSH Terms

Conditions

Hematoma

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ron Auslender, Dr

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Obstetric and Gynecology

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 23, 2011
• Study Start: March 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: May 1, 2014
• Last Updated: May 16, 2014

Record last verified: 2014-05