About this trial
This study aims to elucidate whether there is a difference in long-term prognosis between laparoscopic surgery and open surgery in colon cancer patients with visceral obesity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Body Roundness Index (BRI) ≥ 5.0, with no laparoscopic surgery contraindications as assessed by the surgeon;
Pathologically confirmed colon adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma;
Tumor lower edge > 12 cm from the anus as measured by colonoscopy, and the tumor lower edge not directly palpable by digital rectal examination;
Single primary lesion;
Disqualifiers
Height and waist circumference data are unavailable;
Hereditary colorectal cancer (Lynch syndrome or Familial Adenomatous Polyposis [FAP]);
History of previous malignant neoplasm, with the exception of basal cell carcinoma/papillary thyroid carcinoma/various types of in situ cancers/micro-invasive early-stage lung cancer;
Acute exacerbation of major organ diseases (such as, but not limited to, COPD, coronary heart disease, and renal insufficiency) and/or severe acute infectious diseases (such as, but not limited to, hepatitis, pneumonia, and myocarditis);
Trial design
Parallel
Treatments tested in this trial
Laparoscopic surgery
Procedure/SurgeryIt refers to the scenario where the necessary anatomy for colon cancer resection is performed using laparoscopic instruments. In laparoscopic surgery, conversion to open surgery is defined as making an abdominal wall incision before completing the predetermined necessary anatomical dissection.This study does not permit the use of hand-assisted laparoscopic surgery, single-port laparoscopic surgery, or robotic surgery. The surgery will be performed according to standards of Complete Mesocolic Excision (CME).
Open surgery
Procedure/SurgeryIt refers to a surgical procedure where the surgeon enters the abdominal cavity through an abdominal wall incision, gains adequate surgical space, and performs anatomical dissection under direct visual guidance, without relying on pneumoperitoneum or laparoscopic camera assistance.
Treatment groups
Trial outcomes
Primary outcomes
Three-year disease-free survival (DFS)
Disease free survival(DFS)was defined as the time from randomization to the first occurrence of locoregional recurrence, distant metastasis, any new primary cancer, or death from any cause
Secondary outcomes
Length of colon resected
Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Length of small bowel resected
Limited to right hemicolectomy. Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Distance between tumor and closest arterial vascular division
Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Distance between nearest bowel wall and the same vascular division
Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Other outcomes
Quality of life of patients
The EORTC QLQ-C30 scale was adopted. The corresponding language version was selected according to the patient's place of origin.
Incidence of postoperative abdominal wall incisional hernia
Diagnostic criteria: The surgical incision area in this study is characterized by an abdominal wall defect with abdominal contents protruding outward through the defect; physical examination shows a significant bulging of the hernia mass when standing or when abdominal pressure increases (e.g., coughing, breath-holding), and the hernia mass can spontaneously reduce when lying down (excluding incarcerated/strangulated incisional hernias). The above lesions must be clearly confirmed by abdominal computed tomography (CT) examination (including three-dimensional reconstruction). (Guidelines for diagnosis and treatment of abdominal wall incision hernia (2024 edition), PMID: 39794142)
5-year overall survival rate
The proportion of patients who survived 5 years from randomization.
Sponsors and contacts
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