ADnexal TOrsion Markers Study (ATOMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Roy Mashiach, M.D., Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01659489
First received: July 31, 2012
Last updated: August 4, 2012
Last verified: August 2012
  Purpose

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


Condition
Adnexal Torsion
Laparoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood and Serum Markers in Patients Operated for Suspected Ovarian Torsion

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum will be frozen for evaluation


Estimated Enrollment: 200
Study Start Date: August 2012
Groups/Cohorts
women undergoing laproscopy fo rsuspected adnexal 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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

200 women undergoing laparoscopy for suspected ovarian torsion in a tertiary referral center

Criteria

Inclusion Criteria:

  • women undergoing laparoscopy for suspected ovarian torsion

Exclusion Criteria:

  • elevated liver enzymes
  • suspected ovarian malignancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Roy Mashiach, M.D., Senior Physician, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01659489     History of Changes
Other Study ID Numbers: SHEBA-12-9605-RM-CTIL
Study First Received: July 31, 2012
Last Updated: August 4, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
adnexal torsion
laparoscopy

Additional relevant MeSH terms:
Torsion Abnormality
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014