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NCT05597384
Assessment of Autologous Blood Marker Localization in Laparoscopic Colorectal Cancer Surgery
Conditions: Colorectal Cancer
Sex: All
Ages: 18 Years – 80 Years
Phase: NA
Enrollment: 220
Sponsor: Shanghai East Hospital
Summary
Laparoscopic colorectal surgery has been proved to have similar oncological outcomes with open surgery.
Due to the lack of tactile perception, surgeons may have misjudgments in laparoscopic colorectal surgery.
Therefore, the accurate localization of a tumor before surgery is important, especially in the early stages of cancer.
Recently, some retrospective studies reported the use of patients' autologous blood for preoperative colonic localization in colorectal cancer with successful detection by laparoscopy, but its benefits remain controversial.
This study aimed to assess the accuracy and safety of autogenous blood marker localization in laparoscopic radical resection for colorectal cancer.
Eligibility Criteria
Inclusion Criteria:Age from 18 to 80 yearsLarge lateral spreading tumors that could not be treated endoscopically, serosa-negative malignant colorectal tumors (≤ cT3), and malignant polyps treated endoscopically that required additional colorectal resection.The tumor is located in the colon, middle and high rectum (the lower margin of the tumor does not exceed peritoneal reflexes)No distant metastasis.American Society of Anesthesiology score (ASA) class I-IIIPerformance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)Written informed consentExclusion Criteria:BMI > 35kg/m2Previous history of gastrointestinal surgery that altered the gastrointestinal anatomy.Pregnant or lactating womenSevere mental disorderHistory of previous abdominal surgery (except cholecystectomy and appendectomy) Rejection of laparoscopic resectionHistory of cerebrovascular accident within the past six monthsHistory of unstable angina or myocardial infarction within the past six monthsHistory of previous neoadjuvant chemotherapy or radiotherapyComorbidity of emergent conditions like obstruction, bleeding or perforation.Needing simultaneous surgery for other diseases.
Source: ClinicalTrials.gov (NCT05597384). StuddyBuddy aggregates publicly available trial information.