Sulfur hexafluoride for Adnexal torsion

Inclusion criteria

• {"criterion_text":"- Age 18 or over"}
• {"criterion_text":"- Person who has carried out a preliminary clinical examination adapted to the clinical trial"}
• {"criterion_text":"- Strong suspicion of adnexal torsion with surgery planned,"}
• {"criterion_text":"- No ongoing pregnancy or breastfeeding,"}
• {"criterion_text":"- Affiliation to or beneficiary of a social security scheme,"}
• {"criterion_text":"- Person who has received complete information on the organization"}

Exclusion criteria

• {"criterion_text":"- Non-French-speaking person"}
• {"criterion_text":"- Any medical situation that does not indicate the administration of SonoVue®, including:"}
• {"criterion_text":"- Known hypersensitivity to sulphur hexafluoride or any of the other components of SonoVue"}
• {"criterion_text":"- Woman with acute coronary syndrome or unstable ischemic heart disease"}
• {"criterion_text":"- Woman with acute endocarditis"}
• {"criterion_text":"- Woman with valve prostheses"}
• {"criterion_text":"- Women with acute systemic inflammatory disease and/or sepsis"}
• {"criterion_text":"- Woman with hypercoagulation and/or recent thromboembolic accident"}
• {"criterion_text":"- End-stage woman with kidney or liver disease"}
• {"criterion_text":"- Woman with right-left shunt, severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg)"}
• {"criterion_text":"- Women with uncontrolled systemic hypertension"}
• {"criterion_text":"- Woman with respiratory distress syndrome"}
• {"criterion_text":"- Medical condition contraindicating the administration of SonoVue®,"}
• {"criterion_text":"- History of PEG allergy (or macrogol)"}
• {"criterion_text":"- Person referred to in Articles 10, 31, 32, 33 and 34 of Regulation EU 536/2014"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measure: percentage of emergency surgical procedures (within 6 hours of arrival) without proven torsion, defined as no visible spiral turn at intraoperative inspection."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measure: hospitalization and consultation rates at 1 month; pain at 7 days assessed by numerical scale; rate of secondary surgery with proven torsion at 1 month; rate of listed complications at 1 month."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measure: length of hospitalization (hours/days); collection and recording of intraoperative and postoperative complications; hospitalization and consultation rates at 1 month; pain at 7 days by numerical scale."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Measure: incidence of serious adverse events within 30 minutes post-injection; collection and recording of any delayed hypersensitivity manifestations (cutaneous, respiratory)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measure: collection and comparative analysis of quantitative and qualitative process evaluation data to identify barriers to implementation of contrast ultrasound."}

France

Earliest CTIS Part Ii Submission Date

29-08-2024

Latest Decision Or Authorization Date

30-06-2025

Processing Time Days

305

Number Of Sites

6

Number Of Participants

256

Primary sponsor

Full Name

CHRU De Nancy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France