Blood Perfusion Assessment by Indocyanine Green Fluorescence Imaging for Minimally Invasive Rectal Cancer Surgery (EssentiAL trial): A Randomized Clinical Trial.

"J.W. reports receiving honoraria for lectures from Johnson and Johnson K.K., Medtronic, and Eli Lilly and Company, and receiving research funding from Medtronic, AMCO, and TERUMO outside the submitted work. I.T. reports grants from Stryker Japan during the conduct of the study; grants from Intuitive, grants from Medtronic, and grants from Johnson and Johnson outside the submitted work. T.K. reports receiving honoraria for lectures from Chugai Pharmaceutical Co., Ltd, Ono Pharmaceutical Co., Takeda Pharmaceutical Company Limited, and Eli Lilly and Company. The remaining authors report no conflicts of interest."

"Supported by Stryker Japan K.K. (a subsidiary of Stryker), had no role in the study design, data gathering, analyses, or interpretation, or in the writing of the article or decision to submit the article for publication, other than funding the research."

"The EssentiAL study was an open-label, multicenter, phase III, RCT conducted at 41 hospitals within the framework of the Japan Society of Laparoscopic Colorectal Surgery. The original study protocol and statistical analysis plan were available online (Supplement 1, Supplemental Digital Content 1, http://links.lww.com/SLA/E611 and Supplement 2, Supplemental Digital Content 1, http://links.lww.com/SLA/E611). The study protocol was approved by the Yokohama City University Certified Institutional Review Board, and the institutional review board of each participating hospital before the study was initiated. All the patients provided their written informed consent before enrolling in the study. This study was registered with the Japan Registry of Clinical Trials (jRCTs-CRB3180007) and the Japanese Clinical Trials Registry (UMIN-CTR000030240). The sponsor of the study, Stryker Japan K.K. (a subsidiary of Stryker), had no role in the study design, data gathering, analyses, or interpretation, or in the writing of the article or decision to submit the article for publication, other than funding the research."