Success rate of acquiring informed consent and barriers to participation in a randomized controlled trial of laparoscopic versus open surgery for non-curative stage IV colon cancer in Japan (JCOG1107).
Tomonori AkagiKosuke SuzukiYohei KonoShigeo NinomiyaTomotaka ShibataYoshitake UedaHidefumi ShiroshitaTsuyoshi EtohAkio ShiomiMasaaki ItoJun WatanabeKohei MurataYasumitsu HiranoManabu ShimomuraShunsuke TsukamotoYukihide KanemitsuMasafumi Inomatanull nullPublished in: Japanese journal of clinical oncology (2022)
The success rate of acquiring IC from patients for an RCT of laparoscopic versus open surgery for stage IV colon cancer was lower than the expected rate planned in the protocol. To obtain the planned rate, investigators should make efforts to inform patients and their families about the medical contributions a surgical RCT can make and recognize that the period in equipoise may be limited.