ADnexal TOrsion Markers Study

NCT ID: NCT01659489

Last Updated: 2016-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Brief Summary

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Adnexal torsion , is a severe, though uncommon gynecological emergency, with a prevalence of 2.7-3%. The need for prompt diagnosis and treatment in order to save ovarian tissue has been realized a long time ago. A marker that will aid in the diagnosis of torsion and prevent missed diagnosis and unecessary loss of ovarian tissue, while not increasing the rate of unecessary laparoscopic interventions is much needed. To our knowledge, such marker has not been found. The purpose of this study is to find a marker using blood/serum from patients undergoing laparoscopy for suspected ovarian torsion

Detailed Description

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Adnexal torsion, is a severe, though uncommon gynecological emergency, with a prevalence of 2.7-3% (Taskin 1998; Hibbard1985;Burnett 1988). Torsion commonly occurs in children and women of childbearing age (Haskins 1986).

The need for prompt diagnosis and treatment in order to save ovarian tissue has been realized a long time ago (Ben-Arie 1995). The accuracy of clinical diagnosis is low, with a false negative rate of up to 56% (Cohen 2001, Bar-On 2010,Mashiach 2010). Doppler ultrasound tests, do not "necessarily exclude an ovarian torsion; in fact, "the diagnosis of" torsion is missed in 60% of cases, and time to diagnosis in these cases is delayed" (Pena 2001).

Therefore there is a need for a marker that will aid in the diagnosis of torsion and prevent missed diagnosis and unecessary loss of ovarian tissue, while not increasing the rate of unecessary laparoscopic interventions, which are often performed in an emergency setup, by unqualified personnel.

To our knowledge, such marker has not been found. The purpose of this study is to find a marker, or marker combination, using blood/serum from patients undergoing laparoscopy for suspected ovarian torsion study type: a prospective, controlled, blind study study population: 200 women undergoing laparoscopy for ovarian torsion

Conditions

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Adnexal Torsion Laparoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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women undergoing laproscopy fo rsuspected adnexal torsion

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* women undergoing laparoscopy for suspected ovarian torsion

Exclusion Criteria

* elevated liver enzymes
* suspected ovarian malignancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Roy Mashiach, M.D.

Senior Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The chaim sheba medical center,Tel Hashomer

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Roy Mashiach, MD

Role: primary

+97236130077

Other Identifiers

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SHEBA-12-9605-RM-CTIL

Identifier Type: -

Identifier Source: org_study_id

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