Clinical trial NCT01659489: ADnexal TOrsion Markers Study
Official title: Blood and Serum Markers in Patients Operated for Suspected Ovarian Torsion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adnexal Torsion
Laparoscopy
Keywords: adnexal torsion
laparoscopy
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-08-07
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 women undergoing laparoscopy for suspected ovarian torsion in a tertiary referral center

Brief 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

Detailed 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

Eligibility criteria: Inclusion Criteria:

* women undergoing laparoscopy for suspected ovarian torsion

Exclusion Criteria:

* elevated liver enzymes
* suspected ovarian malignancy

Primary outcomes:
measure: 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.
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: The chaim sheba medical center,Tel Hashomer
Study officials:
References: