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Electronic protocol of clinical data collection in transanal endoscopic microsurgery (TEM): development and application

BACKGROUND: Prospective data collection improves patient care and information access. Written medical records frequently are not well done, due to bad collected data associated to the risk of loosing important items. The use of computer technology in health care system provides better information. OBJECTIVES: To create, computerize and store a clinical database to Transanal Endoscopic Microsurgery (TEM), and it´s incorporation into SINPE© software; to present a descriptive study from 59 patients submitted to TEM. METHODS: Initially was created an Word® questionnaire containing all clinical data concerning to TEM; afterwards, this base was computerized and incorporated into SINPE© and, then, data started to be collected. Later, a descriptive study was done using the database with statistic analysis generated through SINPE©Analisador module. Finally, datamining studies verified patterns and tendencies which could not be visualized from simple data collection. RESULTS: The software allowed creation of TEM protocol. The data stored by collecting 59 patients undergoing the surgical procedure were recovered and analyzed by SINPE©Analisador module, generating charts and statistic automatically. It was found that 74.55% (41) of the patients presented with the diagnosis of adenoma before the surgical procedure. Preoperative staging conducted by transrectal ultrasonography defined most tumors as adenomas (uT0). Ultrasound identified that two lymph nodes were involved. With regard to the depth of the rectal wall resection, it was found that over 60% of the patients who underwent TEM had a full-thickness resection of all rectal wall, i.e., up to the peri-rectal fat. The total number of adenocarcinoma patients was greater in the histopathological study of the surgical specimen than in the preoperative biopsy. The results for the histopathological staging of the surgical specimen revealed differences between pre- and postoperative staging. Incidental carcinoma was present in 13 (31.7%) patients with a preoperative diagnosis of adenoma. An evaluation was conducted of the adenocarcinoma patients who underwent the full-thickness resection of the rectal wall. Postoperative histological review diagnosed 22 patients (37.28% of the patients submitted to TEM) with adenocarcinoma. Of these, 19 underwent resection up to the peri-rectal fat (86.36% of the adenocarcinoma patients). The staging carried out through transrectal ultrasonography identified 24 uT0 tumors. The histopathological examinatin of the surgical specimens showed that 11 were adenomas and nine were carcinomas in situ. Thus, 20 (83.33%) of the 24 tumors that had been staged as uT0 presented a postoperative staging consistent with the preoperative assessment. CONCLUSIONS: SINPE© software is an adequate tool for clinical research and contributed to the accurate and easy management of the prospectively collected data.

Electronic protocol; Rectum neoplasms


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