{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,10,3]],"date-time":"2023-10-03T07:13:57Z","timestamp":1696317237415},"reference-count":25,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2015,7,15]],"date-time":"2015-07-15T00:00:00Z","timestamp":1436918400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"National Cancer Center Research and Development Fund","award":["23-A-16","23-A-19"],"award-info":[{"award-number":["23-A-16","23-A-19"]}]},{"name":"Grant-in-Aid for Cancer Research","award":["14S-3","14S-4","17S-3","17S-5","20S-3","20S-6"],"award-info":[{"award-number":["14S-3","14S-4","17S-3","17S-5","20S-3","20S-6"]}]},{"name":"Health and Labour Sciences Research Grant for Clinical Cancer Research","award":["H15-018","H18-013","H21-017","H24-005"],"award-info":[{"award-number":["H15-018","H18-013","H21-017","H24-005"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Asian J Endoscop Surgery"],"published-print":{"date-parts":[[2015,11]]},"abstract":"Abstract<\/jats:title>Introduction<\/jats:title>Successful completion of randomized controlled trials (RCT<\/jats:styled-content>) is dependent on informed consent (IC<\/jats:styled-content>) acquisition from patients. The aim of this study was to prospectively calculate the proportion of participation in a surgical RCT<\/jats:styled-content> and to identify the reasons for failed IC<\/jats:styled-content> acquisition.<\/jats:p><\/jats:sec>Methods<\/jats:title>A 30\u2010institute RCT<\/jats:styled-content> was conducted to evaluate oncological outcomes of open and laparoscopic surgery for stage II<\/jats:styled-content>\/III<\/jats:styled-content> colon cancer (JCOG0404: UMIN\u2010CTR<\/jats:styled-content> C000000105). The success rate of obtaining IC<\/jats:styled-content>, which was supported by a DVD<\/jats:styled-content> that helped patients understand this trial, was evaluated in eight periods between O<\/jats:styled-content>ctober 2004 and M<\/jats:styled-content>arch 2009. In addition, reasons for failed IC<\/jats:styled-content> acquisition were identified from questionnaires.<\/jats:p><\/jats:sec>Results<\/jats:title>A total of 1767 patients were informed of their eligibility for the trial, and 1057 (60%) were randomly assigned to either the laparoscopic surgery (n<\/jats:italic>\u2009=\u2009529) or open surgery (n<\/jats:italic>\u2009=\u2009528) group. The success rate of IC<\/jats:styled-content> acquisition ranged from 50% to 62% in eight periods. The most common reasons for failed IC<\/jats:styled-content> acquisition were anxiety\/unhappiness about the randomization, patients' preference for one form of surgery, and strong recommendations from referring doctors or relatives.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>With the assistance of a DVD<\/jats:styled-content>, high success rates of IC<\/jats:styled-content> acquisition were obtained for an RCT<\/jats:styled-content> of laparoscopic versus open surgery for stage II<\/jats:styled-content>\/III<\/jats:styled-content> colon cancers. To obtain such a rate, investigators should make efforts to inform patients, their relatives, and referring doctors about the medical contributions a surgical RCT<\/jats:styled-content> can make.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ases.12204","type":"journal-article","created":{"date-parts":[[2015,7,15]],"date-time":"2015-07-15T09:14:47Z","timestamp":1436951687000},"page":"419-423","source":"Crossref","is-referenced-by-count":4,"title":["Success rate of informed consent acquisition and factors influencing participation in a multicenter randomized controlled trial of laparoscopic versus open surgery for stage II<\/scp>\/III<\/scp> colon cancer in J<\/scp>apan (JCOG<\/scp>0404)"],"prefix":"10.1111","volume":"8","author":[{"given":"Tsuyoshi","family":"Etoh","sequence":"first","affiliation":[{"name":"Department of Gastroenterological and Pediatric Surgery Oita University Faculty of Medicine Yufu 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