Adnexal TorsionNCT06324565
Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion
An observational study of Adnexal Torsion, run by IRCCS Burlo Garofolo at 9 sites in 3 countries.
Trial summary
Adnexal torsion is the fifth most common gynecologic emergency. Thirty percent of all cases of adnexal torsion occur in females younger than 20 years. Approximately 5 of 100,000 females aged 1-20 years are affected, with girls older than 10 years at increased risk because of hormonal influences and gonadal growth that… Read more about this study
- Who is it for?
- Ages Up to 17 years, women only
- Conditions the study is for
- Adnexal Torsion
- What is being tested?
- D-Dimer test
- How many people
- 130 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 13 Jan 2022to 13 Dec 2024
- 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 Up to 17 years
- Women only
- No healthy volunteers
- Child
Study population: Girls younger than 18 years of age admitted to the Emergency Department for abdominal pain suspicious for adnexal torsion
Who may be able to join
- Female patients
- Age < 18 years
- presenting with lower quadrants abdominal pain
- Imaging suspicious for adnexal torsion
Who cannot join
- Female patients aged > 18 years
- Previous surgery for adnexal pathologies
- Clinical symptoms and imaging suggesting a different surgical pathology (i.e., appendicitis, gastroenteritis)
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Italy5 sites, 5 recruiting
- Recruiting
IRCCS Giannina Gaslini
Genova
Marcello Carlucci, MD, marcello.carlucci@gaslini.org
- Recruiting
Azienda Ospedale Università Padova
Padova
Federica De Corti, MD, federica.decorti@aopd.veneto.it
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
Mirko Bertozzi, MD, mirkobertozzi@hotmail.it
- Recruiting
Presidio Ospedaliero Santa Chiara
Trento
Enrico Ciardini, MD, enrico.ciardini@apss.tn.it
- Recruiting
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, 34137
Alessandro Boscarelli, MD, +393931757607, alessandro.boscarelli@burlo.trieste.it
Austria2 sites, 2 recruiting
- Recruiting
Medical University of Graz
Graz
Holger Till, MD, holger.till@medunigraz.at
- Recruiting
Medical University of Vienna
Vienna
Maartin Metzelder, martin.metzelder@meduniwien.at
Serbia2 sites, 2 recruiting
- Recruiting
University of Belgrade
Belgrade
Aleksandra Sretinnovic, MD, alexmd64@gmail.com
- Recruiting
University of Novi Sad
Novi Sad
Radoica Jokic, jokic.rs@gmail.com
About this study
Official title: The Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion in Children and Adolescents
Adnexal torsion is the fifth most common gynecologic emergency. Thirty percent of all cases of adnexal torsion occur in females younger than 20 years. Approximately 5 of 100,000 females aged 1-20 years are affected, with girls older than 10 years at increased risk because of hormonal influences and gonadal growth that result in an increased frequency of physiologic and pathologic masses. The most common clinical symptom of torsion is sudden-onset abdominal pain that is intermittent, non-radiating, and associated with nausea and vomiting in 62% and 67% of cases respectively. Moreover, abdominal tenderness is a clinical sign which is reported in up to 88% of patients with adnexal torsion. None of the following tests are useful in the diagnosis of adnexal torsion: leukocytosis, pyuria, C-reactive protein, and erythrocyte sedimentation rate. Actually, transabdominal ultrasonography is the imaging modality of choice with a sensitivity of 92% and specificity of 96% in detecting adnexal torsion. A second-line imaging tool in the diagnosis of adnexal torsion is magnetic resonance, which may require a sedation in selected cases. Consequently, there are no clinical or imaging criteria sufficient to confirm the preoperative diagnosis of adnexal torsion to date. Therefore, patients with a clinical suspicion for adnexal torsion should undergo emergent diagnostic laparoscopy.
- Conditions
- Adnexal Torsion
- Being tested
- D-Dimer test
- Keywords
- D-dimer, Diagnosis, Adnexal torsion
- Medical subject headings
- Ovarian Torsion, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-Dimer testDiagnostic test
All patients in whom preoperative diagnostics have not been able to exclude a surgical pathology and who are candidates for diagnostic-therapeutic surgery will be referred for minimally invasive abdominal exploration in the real suspicion of ovarian torsion. During the pre-operative phase, blood exams will be performed including coagulation which will be integrated with the D-dimer values. In addition, as usual, the clinical examination of the patients will be performed integrated with the various diagnostic image tools generally used in this category of patients (abdomen ultrasound +/- magnetic resonance in urgency).
| Study group | Role | What they receive |
|---|---|---|
| Ovarian Torsion | All female patients under the age of 18 with suspicious signs and symptoms of ovarian torsion Receives: Diagnostic Test: D-Dimer test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the D-Dimer
Area under the Receiver Operating Characteristic (ROC) curve (AUC) will be assessed to evaluate the diagnostic accuracy of the D-Dimer
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start13 Jan 2022
- Primary completion13 Dec 2024 (estimated)
- Study completion13 Dec 2024 (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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324565
- Sponsor's protocol ID
- RC 24/2021
- Status last verified
- Jun 2024
- First submitted
- 15 Mar 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion in Children and Adolescents
- ClinicalTrials.gov ID
- NCT06324565
- Acronym / sponsor ID
- RC 24/2021
- Conditions
- Adnexal Torsion
- Keywords
- D-dimer, Diagnosis, Adnexal torsion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 13 Dec 2024 (estimated)
- Study completion
- 13 Dec 2024 (estimated)
- First posted
- 22 Mar 2024 (actual)
- 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 the fifth most common gynecologic emergency. Thirty percent of all cases of adnexal torsion occur in females younger than 20 years. Approximately 5 of 100,000 females aged 1-20 years are affected, with girls older than 10 years at increased risk because of hormonal influences and gonadal growth that result in an increased frequency of physiologic and pathologic masses. The most common clinical symptom of torsion is sudden-onset abdominal pain that is intermittent, non-radiating, and associated with nausea and vomiting in 62% and 67% of cases respectively. Moreover, abdominal tenderness is a clinical sign which is reported in up to 88% of patients with adnexal torsion. None of the following tests are useful in the diagnosis of adnexal torsion: leukocytosis, pyuria, C-reactive protein, and erythrocyte sedimentation rate. Actually, transabdominal ultrasonography is the imaging modality of choice with a sensitivity of 92% and specificity of 96% in detecting adnexal torsion. A second-line imaging tool in the diagnosis of adnexal torsion is magnetic resonance, which may require a sedation in selected cases. Consequently, there are no clinical or imaging criteria sufficient to confirm the preoperative diagnosis of adnexal torsion to date. Therefore, patients with a clinical suspicion for adnexal torsion should undergo emergent diagnostic laparoscopy.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian Torsion | – | Diagnostic Test: D-Dimer testAll female patients under the age of 18 with suspicious signs and symptoms of ovarian torsion |
Who may qualify
- Ages
- Up to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Girls younger than 18 years of age admitted to the Emergency Department for abdominal pain suspicious for adnexal torsion
Key inclusion criteria (4 listed)
- Female patients
- Age < 18 years
- presenting with lower quadrants abdominal pain
- Imaging suspicious for adnexal torsion
Key exclusion criteria (3 listed)
- Female patients aged > 18 years
- Previous surgery for adnexal pathologies
- Clinical symptoms and imaging suggesting a different surgical pathology (i.e., appendicitis, gastroenteritis)
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 |
|---|---|---|
| D-Dimer testAll patients in whom preoperative diagnostics have not been able to exclude a surgical pathology and who are candidates for diagnostic-therapeutic surgery will be referred for minimally invasive abdominal exploration in the real suspicion of ovarian torsion. During the pre-operative phase, blood exams will be performed including coagulation which will be integrated with the D-dimer values. In addition, as usual, the clinical examination of the patients will be performed integrated with the various diagnostic image tools generally used in this category of patients (abdomen ultrasound +/- magnetic resonance in urgency). | Diagnostic test | Ovarian Torsion |
Primary outcome
Diagnostic accuracy of the D-Dimer
Time frame: Through study completion, an average of 18 months
Area under the Receiver Operating Characteristic (ROC) curve (AUC) will be assessed to evaluate the diagnostic accuracy of the D-Dimer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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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.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adnexal Torsion, run by IRCCS Burlo Garofolo at 9 sites in 3 countries.
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 4 inclusion and 3 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Austria, Serbia. 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 Alessandro Boscarelli, MD (+393931757607, alessandro.boscarelli@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the D-Dimer (time frame: Through study completion, an average of 18 months). 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 13 Jun 2024.