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[Members Only] J.Jpn. Surg. Soc.. 125(2): 131-138, 2024
Feature topic
RANDOMIZED, CONTROLLED TRIALS IN LOWER GASTROINTESTINAL SURGERY: THE ROAD TO TOP JOURNALS
The first large-scale, randomized, controlled trials (RCTs) of surgical treatment of the lower gastrointestinal tract in Japan were the JCOG0404, JCOG0212, and JOCG1006 trials designed by the Colorectal Cancer Group of the Japanese Clinical Oncology Group (JCOG) about 20 years ago. As RCTs of surgical therapy, many facilities and colorectal surgeons throughout Japan participated in those trials, spending a large amount of time from the planning stage to the establishment of detailed protocols, enrollment of patients, and analysis of results. The trials have overcome many challenges and solved clinical questions, and the results have been published in top journals. In this report, we provide an overview of the three trials, efforts made to conduct them, and future prospects for RCTs. Currently, the results of those trials have generated additional clinical questions, and successor trials are ongoing. The ongoing trial in our institution aims to develop a new multimodality therapy that combines surgery and chemoradiotherapy, and the results are expected in the near future.
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