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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01659489
Other study ID # SHEBA-12-9605-RM-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received July 31, 2012
Last updated April 19, 2016
Start date August 2012

Study information

Verified date April 2016
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- women undergoing laparoscopy for suspected ovarian torsion

Exclusion Criteria:

- elevated liver enzymes

- suspected ovarian malignancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel The chaim sheba medical center,Tel Hashomer Ramat Gan

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum level of blood proteins (complete list available by direct contact)will be measured before and after ovarian detorsion, and will be compared to those taken from patients who were underwent diagnostic laparoscopy for suspected ovarian torsion. Blood will be withrawed before and within 12 hourse after the surgery. The results will be analysed after recruitment and blood withrawal is finished. not later than three years after the begining of the trial No
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