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COVARIAN : Contribution of contrast enhanced ultrasound for diagnosis of adnexal torsion: a randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511720-13-00
Acronym
2021PI162
Enrollment
256
Registered
2024-10-28
Start date
2025-05-14
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adnexal torsion

Brief summary

Percentage of surgical procedures performed in emergency (within 6 hours of arrival of the patient) without proven torsion (no visible spiral turn in intraoperative) in each group.

Detailed description

To meet secondary objective #1: Rate of hospitalization and rate of consultation at 1 month, pain at 7 days evaluated by a numerical scale, rate of secondary surgery with proven torsion at 1 month, rate of complications (pelvic abscess, pelviperitonitis, necrotic aspect of the ovary, non conservative treatment) at 1 month., To meet secondary objective #2: -Length of hospitalization expressed in hours or days, -Collection of intraoperative complications (during hospitalization): hemorrhage, vascular wound, digestive wound, -Collection of postoperative complications at 1 month: secondary hemorrhage, surgical resumption (whatever the reason), scar disunity, scar abscess, -Hospitalization rate and consultation rate at 1 month, -7-day pain assessed by numerical scale., To meet secondary objective #3: Incidence of serious adverse events within 30 minutes of injection of SonoVue® and collection of any delayed hypersensitivity manifestations (skin, respiratory)., To meet secondary objective #4:Quantitative and qualitative data from the process evaluation will be compared to identify and remove potential obstacles to the use of contrast ultrasound in cases of suspected adnexal torsion.

Interventions

Sponsors

CHRU De Nancy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of surgical procedures performed in emergency (within 6 hours of arrival of the patient) without proven torsion (no visible spiral turn in intraoperative) in each group.

Secondary

MeasureTime frame
To meet secondary objective #1: Rate of hospitalization and rate of consultation at 1 month, pain at 7 days evaluated by a numerical scale, rate of secondary surgery with proven torsion at 1 month, rate of complications (pelvic abscess, pelviperitonitis, necrotic aspect of the ovary, non conservative treatment) at 1 month., To meet secondary objective #2: -Length of hospitalization expressed in hours or days, -Collection of intraoperative complications (during hospitalization): hemorrhage, vascular wound, digestive wound, -Collection of postoperative complications at 1 month: secondary hemorrhage, surgical resumption (whatever the reason), scar disunity, scar abscess, -Hospitalization rate and consultation rate at 1 month, -7-day pain assessed by numerical scale., To meet secondary objective #3: Incidence of serious adverse events within 30 minutes of injection of SonoVue® and collection of any delayed hypersensitivity manifestations (skin, respiratory)., To meet secondary objective #4

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026