Cranioplasty for isolated mild trigonocephaly with developmental conditions and continuing ignorance of Helsinki declaration

Abstract

The ignorance of Helsinki declaration is continuing in Japan for approximately 20 years. More than 400 children including preschoolers with developmental conditions including temper tantrums, hyperactivity, and/or autistic characteristics have been already operated. The cranioplasty for isolated mild trigonocephaly had been empirically introduced by a physician to re-establish the brain spatial environment, and a government-granted and multi-centered clinical observation study is now in operation without scientific verification of the procedure’s validity. The characteristic of the skull shape are too mild and sometimes too subtle to be recognized by the parents and health checkup doctors. A physician may tentatively and extraordinarily use an unproven procedure in exceptional circumstances where proven and effective interventions do not exist. However, the intervention must as soon as possible be subjected to scientific scrutiny according to ethical principles in order to stop the utilization in case of misprediction (no evidence of the efficacy).