Adnexal TorsionATOMSNCT01659489
ADnexal TOrsion Markers Study
An observational study of Adnexal Torsion and Laparoscopy, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Adnexal Torsion, Laparoscopy
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2012to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: 200 women undergoing laparoscopy for suspected ovarian torsion in a tertiary referral center
Who may be able to join
- women undergoing laparoscopy for suspected ovarian torsion
Who cannot join
- elevated liver enzymes
- suspected ovarian malignancy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The chaim sheba medical center,Tel Hashomer
Ramat Gan, 52503
Roy Mashiach, MD, +97236130077, rmashiach@013.net.il
About this study
Official title: Blood and Serum Markers in Patients Operated for Suspected Ovarian Torsion
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
Read the 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
- Conditions
- Adnexal Torsion, Laparoscopy
- Keywords
- adnexal torsion, laparoscopy
- Medical subject headings
- Ovarian Torsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women undergoing laproscopy fo rsuspected adnexal torsion | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adnexal TorsionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Roy Mashiach, M.D., Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659489
- Sponsor's protocol ID
- SHEBA-12-9605-RM-CTIL
- Acronym
- ATOMS
- Status last verified
- Apr 2016
- First submitted
- 31 Jul 2012
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood and Serum Markers in Patients Operated for Suspected Ovarian Torsion
- ClinicalTrials.gov ID
- NCT01659489
- Acronym / sponsor ID
- ATOMS / SHEBA-12-9605-RM-CTIL
- Conditions
- Adnexal Torsion, Laparoscopy
- Keywords
- adnexal torsion, laparoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2012
- Primary completion
- Dec 2016 (estimated)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women undergoing laproscopy fo rsuspected adnexal torsion | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 200 women undergoing laparoscopy for suspected ovarian torsion in a tertiary referral center
Key inclusion criteria (1 listed)
- women undergoing laparoscopy for suspected ovarian torsion
Key exclusion criteria (2 listed)
- elevated liver enzymes
- suspected ovarian malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adnexal Torsion and Laparoscopy, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.