Surgery versus intra-lesional sclerosis with polidocanol (Aetoxisclerol) in labial venous malformations in children and adults: a randomized controlled trial - SASOV

superficial labial venous malformation

Assessment of overall effectiveness (including regression in lesion volume, scar quality, and lip symmetry): Efficacy will be assessed 12 months after the procedure on a Likert scale, based on photographs taken before and after the procedure, evaluated by an adjudication committee consisting of three physicians and one patient with a lip vein malformation who did not participate in the study. This assessment will be performed blind to the arm.

Effectiveness on the aesthetic impact of venous malformation at 12 months: comparison of the visual analog scale (VAS) for aesthetic discomfort at inclusion and at M12 (completed by parents if the patient is a child < 6 years old), Effectiveness on the functional impact of venous malformation at 12 months: comparison of the visual analog scale (VAS) for overall mouth function, a self-administered questionnaire on drooling (Drooling Severity and Frequency Scale), and a self-administered questionnaire on speech intelligibility (Intelligibility in Context Scale [ICS]) at inclusion and at M12 (completed by parents if the child is < 6), Overall patient satisfaction (and/or parents if the patient is a child < 6 years of age), measured on a Likert scale at 12 months and via personalized goals predefined by the patient with the investigator (Goal Attainment Scale [GAS]), Total number of painful days and painful days with VAS > 3/10 related to the venous malformation in the month preceding, the month following the procedure, and in the month preceding M12 (recorded in a patient diary), Volume of the venous malformation on MRI at inclusion and at 12 months (performed in routine care), Impact on coagulation (D-dimers and fibrinogen), Safety: adverse effects, complications, Patient acceptance of interventions, assessed by a VAS (by parents in the case of children < 6 years of age) measured at M1, M3, and M12, Difference in total average cost of care between strategies from the perspective of the healthcare system, Impact on coagulation (D-dimer and fibrinogen)

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