Ethical issues in the case of surgical repair of cleft palate.

There are some advantages to prospective randomized clinical trials (PRCT) to resolve some limited clinical problems. But, when this method is used to determine the best surgical procedure to close the palatal cleft space, there are strong ethical considerations that cannot be overcome. There are two basic problems. The first is having the surgeon perform surgical procedures which he/she does not believe is the treatment of choice or that can be performed as skillfully as others, even after demonstrations. Secondly, this method does not consider the theoretical aspect that many clefts within the same cleft type are different in the relative size of cleft space to size of soft tissue available for closing the cleft space, thereby creating different degrees of scarring. Different outcomes to the same surgery must, therefore, result irrespective of the surgeons' skills or treatment plans. Retrospective research studies, whether they involve one or more institutions, have been and are still very valuable in improving the knowledge base of all areas of cleft palate habilitation.