Ovarian TorsionNCT01880905
The Length of Uteroovarian Ligament and the Risk of Ovarian Torsion
A study testing Measure of uteroovarian ligament length during gynecological surgery in people with Ovarian Torsion, run by Meir Medical Center at 1 site in Israel.
Trial summary
Ovarian torsion is one of the gynecological emergency. This complication requires high clinical suspicion and early detection, to prevent permanent loss of ovarian function. The long uterine ovarian ligament could be a risk factor for ovarian torsion. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Ovarian Torsion
- What is being tested?
- Measure of uteroovarian ligament length during gynecological surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2013to Jul 2014
- Phase
- Interventional
- 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 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Indication for gynecological operation
- hemodynamically stable
Who cannot join
- Ovarian torsion in the past
- History of pelvic inflammatory disease (PID)
Trial locations and contacts
1 site in 1 country.
Rina Tamir, MD contact
Israel1 site
Meir Medical Center
Kfar Saba
Amir Wiser, 97297472227, amir.wiser@gmail.com
Amir Wiser, MD
About this study
Ovarian torsion is one of the gynecological emergency. This complication requires high clinical suspicion and early detection, to prevent permanent loss of ovarian function. The long uterine ovarian ligament could be a risk factor for ovarian torsion. We want to measure the uterine ovarian ligament length during routine laparoscopy/laparotomy and to compare the length between the torsion group and other non torsion patients
Read the detailed description
Female patient who are going to undergo laparoscopy/laparotomy for any gynecological reason will ask to participate. During the operation the uteroovarian ligament length will be measure by sterile ruler (calibrated plastic device 1 mm in diameter).
The length of uteroovarian ligament will compared between the patient who will diagnose with ovarian torsion (study group) and the other women (control group)
- Conditions
- Ovarian Torsion
- Being tested
- Measure of uteroovarian ligament length during gynecological surgery
- Keywords
- the length of uterine ovarian ligament
- Medical subject headings
- Ovarian Torsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of uteroovarian ligament length during gynecological surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| female undergoing gynecological surgery | Experimental | Not described Receives: Procedure: Measure of uteroovarian ligament length during gynecological surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
uteroovarian ligament length
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Wiser, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880905
- Sponsor's protocol ID
- 0031-13-MMC
- Status last verified
- Apr 2013
- First submitted
- 11 Jun 2013
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Length of Uteroovarian Ligament and the Risk of Ovarian Torsion
- ClinicalTrials.gov ID
- NCT01880905
- Acronym / sponsor ID
- 0031-13-MMC
- Conditions
- Ovarian Torsion
- Keywords
- the length of uterine ovarian ligament
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 19 Jun 2013 (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.
Ovarian torsion is one of the gynecological emergency. This complication requires high clinical suspicion and early detection, to prevent permanent loss of ovarian function. The long uterine ovarian ligament could be a risk factor for ovarian torsion. We want to measure the uterine ovarian ligament length during routine laparoscopy/laparotomy and to compare the length between the torsion group and other non torsion patients
Detailed description
Female patient who are going to undergo laparoscopy/laparotomy for any gynecological reason will ask to participate. During the operation the uteroovarian ligament length will be measure by sterile ruler (calibrated plastic device 1 mm in diameter).
The length of uteroovarian ligament will compared between the patient who will diagnose with ovarian torsion (study group) and the other women (control group)
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| female undergoing gynecological surgery | Experimental | Procedure: Measure of uteroovarian ligament length during gynecological surgery |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Indication for gynecological operation
- hemodynamically stable
Key exclusion criteria (2 listed)
- Ovarian torsion in the past
- History of pelvic inflammatory disease (PID)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of uteroovarian ligament length during gynecological surgery | Procedure or surgery | female undergoing gynecological surgery |
Primary outcome
uteroovarian ligament length
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion
Adnexal Torsion
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.
Rina Tamir, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure of uteroovarian ligament length during gynecological surgery in people with Ovarian Torsion, run by Meir 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 2 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 19 Jun 2013. 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?
Contact Amir Wiser (97297472227, amir.wiser@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uteroovarian ligament length (time frame: 1 minute). 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 19 Jun 2013.