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difficulties in recruiting patients
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | Experimental | Diagnosis of adnexal torsion confirmed by the surgical intervention: woman allocated to case group |
|
| Control group | Experimental | Diagnosis of adnexal torsion not confirmed by the surgical intervention: woman allocated to control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast enhanced ultrasound | Diagnostic Test | Acquisition of contrast enhanced ultrasound. Contrast agent: SonoVue®: Hexafluoride (SonoVue®, injectable solution to solubilisate, 8µg/mL) is injected in all patients |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, on average of 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| vascularization of the ovaries on contrast enhanced ultrasound. | Measurement of perfusion parameters of the suspected ovarian torsion and the contralateral ovary if available: | through study completion, an average of 36 months |
| diagnostics performance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charline BERTHOLDT | Central Hospital, Nancy, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Régional Universitaire de Nancy | Nancy | 54000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37620263 | Background | Pillot R, Hossu G, Cherifi A, Guillez K, Morel O, Beaumont M, Fijean AL, Bertholdt C. Contribution of contrast-enhanced ultrasound in the diagnosis of adnexal torsion (AGATA): protocol for a prospective comparative study. BMJ Open. 2023 Aug 24;13(8):e073301. doi: 10.1136/bmjopen-2023-073301. | |
| 40761032 | Result |
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| ID | Term |
|---|---|
| D000082843 | Ovarian Torsion |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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Phase 3b, prospective, Case-Control study
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Measurement of signal intensities to assess sensibility and specificity of contrast enhanced ultrasound and bidimensional (2D) Doppler. |
| 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. | 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 | through study completion, an average of 36 months |
| Micro Vascular Flow technique | Measurement of signal intensities obtained by Micro Vascular Flow technique | 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. | 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 | through study completion, an average of 36 months |
| Fijean AL, Hossu G, Cherifi A, Beaumont M, Morel O, Bertholdt C. Improving diagnostic accuracy of ovarian torsion using contrast-enhanced ultrasound: A prospective comparative clinical study of performance diagnosis. Int J Gynaecol Obstet. 2026 Feb;172(2):1151-1158. doi: 10.1002/ijgo.70429. Epub 2025 Aug 5. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D014102 | Torsion Abnormality |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |