Study design and setting, and participant
tumor, bleeding, serosa-negative malignant colorectal tumors, unstable angina or myocardial infarction, cerebrovascular accident, Comorbidity, tumors, colorectal resection
TUMOR, BLEEDING, RECRUITMENT, CEREBROVASCULAR ACCIDENT, BLIND, ONCOLOGY, TUMORS, DISEASES
The trial is designed as a randomized, controlled, single center no inferiority trial with two parallel groups and a primary endpoint of localization accuracy during laparoscopic colectomy, which will take place in the Department of Gastrointestinal Surgery, Shanghai East Hospital, Tongji University, Shanghai, China (Fig. Key inclusion and exclusion criteria of the trial• Age from 18 to 80 years• Large lateral spreading tumors that could not be treated endoscopically, malignant polyps treated endoscopically that required additional colorectal resection, and serosa-negative malignant colorectal tumors (≤ cT3)• The tumor located in the colon, middle and high rectum (The lower edge of the tumor located above the peritoneal reflexes)• No distant metastasis• American Society of Anesthesiology score (ASA) class I-III• Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)• Written informed consent• BMI > 35 kg/m2• Previous history of gastrointestinal surgery that altered the gastrointestinal anatomy.• Pregnant or lactating women• Severe mental disorder• History of previous abdominal surgery (except cholecystectomy and appendectomy)• Rejection of laparoscopic resection• History of cerebrovascular accident within the past six months• History of unstable angina or myocardial infarction within the past six months• History of previous neoadjuvant chemotherapy or radiotherapy• Comorbidity of emergent conditions like obstruction, bleeding or perforation.• Needing simultaneous surgery for other diseases.After completing an initial assessment and signing an informed consent form, participants will be randomized with 1:1 ratio into two groups: autologous blood marker group and intraoperative colonoscopy group. The data manager, who will not be involved in eligibility assessment and recruitment of patients, will perform the randomization with a list of randomly ordered treatment identifiers generated by a permuted block design using SAS (version 9.1; SAS Institute Inc.). Although it will not be feasible to blind the surgeons and participants, the researcher performing the statistical analyses will be blinded to the patient group allocation.This protocol and the informed consent forms have been reviewed and approved by Shanghai East Hospital and Institute Ethics Review Committee. We will obtain a new approval from the Committee if any amendments are made to the protocol or the informed consent form that may have an impact on the conduct of the study or potential benefit of the patient. A signed consent must be obtained from every participant in the ancillary study, if the data collection/request is not covered in the original informed consent process for the main clinical trial. The study has been registered in Clinical-Trial.gov (NCT05597384).