Adnexal Torsion
Conditions
Keywords
adnexal, torsion, ovarian, contrast enhanced ultrasound
Brief summary
Clinical diagnosis of adnexal torsion is difficult because the symptomatology is dominated by abrupt onset pelvic pain, an aspecific sign which does not allow a diagnosis of certainty to be made. To confirm the diagnosis, the reference examination is pelvic ultrasound with Doppler flow analysis. However, its intake is low, its sensitivity varies from 46 to 73% depending on the studies. Other imaging techniques have been considered, such as MRI, with a sensitivity far superior to ultrasound, but its difficult accessibility, in particular in the context of an emergency, makes it unusable in clinical practice. The use of ultrasound with the injection of an ultrasound contrast agent, strict intravascular, seems to be an interesting technique to assess the perfusion parameters of the ovary and improve the diagnostic sensitivity of the adnexal torsion. Its interest has already been demonstrated in the diagnosis of testicular torsion in animals but to date, no study has evaluated its contribution in adnexal torsion.
Detailed description
The primary objective is to evaluate the diagnostic performance of contrast enhanced ultrasound for the diagnosis of adnexal torsion in women with suspected adnexal torsion. The secondary objectives are: 1. To describe the perfusion parameters of the ovaries by contrast enhanced ultrasound 2. To compare performance diagnosis of contrast ultrasound and bidimensional Doppler for the detection of adnexal torsion. 3. To describe the perfusion parameters of the ovarian as a function of the degree of adnexal torsion. 4. To compare perfusion parameters before and after ovarian detorsion 5. To describe perfusion parameters of the ovarian by using MicroVascular Flow technique 6. To assess the contribution of qualitative contrast ultrasound for the diagnosis of adnexal torsion (without clinical context) 7. To assess inter-observer agreement on the qualitative analysis of ultrasound, without clinical context and then with clinical context.
Interventions
DIAGNOSTIC_TESTContrast enhanced ultrasound
Acquisition of contrast enhanced ultrasound. Contrast agent: SonoVue®: Hexafluoride (SonoVue®, injectable solution to solubilisate, 8µg/mL) is injected in all patients
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Phase 3b, prospective, Case-Control study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Woman over 18 years old * Woman affiliated to a social security * Woman having received complete information on the organization of the research and having given her informed consent in written form. * Planned surgical intervention for suspected adnexal torsion
Exclusion criteria
* Patients under a measure of legal protection, * Contraindication to contrast injection Hypersensitivity to sulfur hexafluoride or any of the other ingredients, history of cardiac disease, respiratory distress syndrome, severe pulmonary hypertension..
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signal intensity measurement | through study completion, on average of 36 months | to assess sensitivity, specificity, positive and negative predictive value of contrast enhanced ultrasound for detection of adnexal torsion in women with suspected adnexal torsion with realization of ROC curves |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| diagnostics performance | through study completion, an average of 36 months | Measurement of signal intensities to assess sensibility and specificity of contrast enhanced ultrasound and bidimensional (2D) Doppler. |
| vascularization of the ovaries according to the degree of torsion | through study completion, an average of 36 months | Comparison of perfusion parameters of the ovary with the degree of torsion. The degree of torsion is defined by the number of twists (number of turns around the axis) detected during the surgical procedure. |
| vascularization of the ovaries before and after detorsion | through study completion, an average of 36 months | Measurement of signal intensities before and after ovarian detorsion |
| vascularization of the ovaries on contrast enhanced ultrasound. | through study completion, an average of 36 months | Measurement of perfusion parameters of the suspected ovarian torsion and the contralateral ovary if available: |
| Qualitative evaluation of contrast enhancement | through study completion, an average of 36 months | Presence or absence of contrast within the ovary. The presence of torsion is defined as for the primary objective. |
| Reproducibility of qualitative evaluation of contrast enhancement | through study completion, an average of 36 months | Diagnosis of adnexal torsion assessed by two observer on qualitative contrast ultrasound, without and with clinical context. Concordance will be assessed by the kappa coefficient |
| Micro Vascular Flow technique | through study completion, an average of 36 months | Measurement of signal intensities obtained by Micro Vascular Flow technique |
Countries
France
Outcome results
None listed