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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
11
Acquisition of contrast enhanced ultrasound. Contrast agent: SonoVue®: Hexafluoride (SonoVue®, injectable solution to solubilisate, 8µg/mL) is injected in all patients
Centre Hospitalier Régional Universitaire de Nancy
Nancy, France
Signal intensity measurement
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
Time frame: through study completion, on average of 36 months
vascularization of the ovaries on contrast enhanced ultrasound.
Measurement of perfusion parameters of the suspected ovarian torsion and the contralateral ovary if available:
Time frame: through study completion, an average of 36 months
diagnostics performance
Measurement of signal intensities to assess sensibility and specificity of contrast enhanced ultrasound and bidimensional (2D) Doppler.
Time frame: through study completion, an average of 36 months
vascularization of the ovaries according to the degree of torsion
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.
Time frame: through study completion, an average of 36 months
vascularization of the ovaries before and after detorsion
Measurement of signal intensities before and after ovarian detorsion
Time frame: through study completion, an average of 36 months
Micro Vascular Flow technique
Measurement of signal intensities obtained by Micro Vascular Flow technique
Time frame: through study completion, an average of 36 months
Qualitative evaluation of contrast enhancement
Presence or absence of contrast within the ovary. The presence of torsion is defined as for the primary objective.
Time frame: through study completion, an average of 36 months
Reproducibility of qualitative evaluation of contrast enhancement
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
Time frame: through study completion, an average of 36 months
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