This paper reports a case of a transcranial surgery in a patient with a symptomatic Rathke’s cleft cyst. The patient was a 54-year-old woman visited us with a chief complaint about chronic retrobulbar pain. Goldmann visual field tests revealed visual field defects in the bitemporal upper quadrant part and enlargement of the bilateral blind spot of Mariotte. MRI demonstrated a cystic lesion in the intra suprasellar region. The cyst was located on the pipuitary gland. The content of the cyst displayed hyperintensity on T1WI and hypointensity on T2WI, respectively. The diaphragma sellae was elevated and extended by the cyst. Considering a locational relationship between the cyst and the pituitary gland, and high viscosity of the cyst content, we decided to perform a transcranial surgery for an adequate resection of the cyst wall and evacuation of the content. The patient underwent a right fronto-temporal craniotomy with extradural anterior clinoidectomy. The cyst content was evacuated and the cyst wall was resected. The content was very viscid and waxy. Pathologic examination revealed that the cyst wall consisted of single or multiple ciliated columnar cells. Inflammatory cellular infiltration was also observed in the cyst wall. Retrobulbar pain subsided just after the operation and visual field disturbance also disappeared.

The Standardized Structured Medical record Information eXchange (SS-MIX) was started in 2006 as the project supported by the Ministry of Health, Labour and Welfare (MHLW) for promoting the exchange of the standardized medical information. Free soft wares developed in the project allow the storage of medical information to receive HL7 messages for prescription, laboratory test results, diagnoses and patient demographics in the hospital information system (HIS). We encourage the use of the SS-MIX standardized storage for postmarketing surveys and clinical studies. The recommendations consist of the following 7 parts. [1] In surveys and clinical studies, the information of drugs and laboratory test results in the SS-MIX standardized storage can be directly transferred to the electronic questionnaire and the investigators may obtain the information with high accuracy and granularity. [2] The SS-MIX standardized storage works as the backup system for the HIS because it can provide the minimum information essential in patient care even under the disastrous condition like earthquake or unexpected network failure. [3] The SS-MIX standardized storage may be useful to conduct a good pharmacoepidemiology study not only because it provides the information in the storage efficiently but also it can be used to identify “new users” who started the drug after some period of non-use.The “new user” design is often essential to have the unbiased results. [4] When the drug company conducts postmarketing surveys according to the current regulation, the use of the SS-MIX standardized storage will facilitate the fast and efficient collection of data to develop the timely measure to minimize the drug-related risk. With the SS-MIX standardized storage, it is also expected that many types of study design can be employed and the quality of data is improved in the survey. [5] The SS-MIX standardized storage maybe also useful to evaluate the risk minimization action plan by comparing the prescription pattern or incidence of the targeted adverse event between two periods before and after the implementation of the action plan. [6] In planning clinical trials, the SS-MIX standardized storage may be used to estimate the size of eligible patients. The storage may also allow conducting cross-sectional studies to know characteristics of diseases or drug treatment. In addition, cohorts of those who had coronary artery angiography, new users of a drug and those with a rare disease may be readily identified. Using such cohorts, investigators can initiate a case-control study nested within the cohort, pharmacogenomic studies and comparative effectiveness researches. [7] The SS-MIX standardized storage may be used as the formal data source in clinical trials in the future when some conditions are satisfied. For instance, the formal agreement should be reached between industry, government and academia on the use of standards of data structure in Clinical Data Interchange Standards Consortium (CDISC) and on the operation of computerized system validation (CSV) in the clinical trials.