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.
Study on Surgical Approaches for Colon Cancer Patients with Visceral Obesity Colorectal cancer stands as a major malignant tumor threatening human health. Laparoscopic surgery has been widely adopted in colon cancer treatment, as it yields comparable survival outcomes to open surgery while offering the advantage of minimal invasiveness. However, with the global escalation of obesity, laparoscopic intervention becomes increasingly challenging in colon cancer patients with visceral obesity, potentially compromising surgical quality. Notably, earlier landmark studies including COST, COLOR, and CLASICC have confirmed that laparoscopic surgery is non-inferior to open surgery in colon cancer patients. Nevertheless, these studies enrolled relatively lean patients with a Body Mass Index (BMI) below the average level of their respective regions; the COLOR study even excluded patients with a BMI exceeding 30 kg/m². Additionally, transverse colon cancer and splenic flexure colon cancer were excluded from these trials, rendering their data insufficiently representative of the growing population of obese colon cancer patients. In contrast, the JCOG0404 study specifically demonstrated that colon cancer patients with a BMI ≥ 25 kg/m² had significantly poorer prognostic outcomes after laparoscopic surgery compared to open surgery. Further evidence from European waist-to-hip ratio studies and meta-analyses indicates that obese patients-especially those with abdominal obesity-pose greater surgical challenges. For such patients, laparoscopic surgery is associated with fewer harvested lymph nodes, higher conversion rates to open surgery, and potentially compromised surgical quality, which may ultimately lead to inferior long-term prognosis. The Body Round Index (BRI), calculated using height and waist circumference, serves as a robust predictor of Visceral Fat Area (VFA). It exhibits superior performance to traditional anthropometric indicators such as BMI, waist circumference, and waist-to-hip ratio. Based on BRI and BMI data from Chinese and American populations, as well as clinical observations by the research team, patients with a BRI ≥ 5.0 present with significant visceral fat accumulation, which substantially increases the complexity of surgical procedures. This study is designed as a prospective, international, multicenter, randomized, open-label, parallel-controlled trial to clarify whether open surgery is superior to laparoscopic surgery in terms of long-term outcomes for colon cancer patients with visceral obesity (defined as BRI ≥ 5.0). Eligible participants meeting all inclusion criteria will be enrolled and randomly assigned in a 1:1 ratio to either the laparoscopic surgery group or the open surgery group. Both groups will undergo surgery adhering to the Complete Mesocolic Excision (CME) standard. Postoperatively, patients will be followed up for 5 years in accordance with the predefined follow-up protocol. The primary outcome measure is the 3-year disease-free survival rate, while secondary outcomes include specimen quality, 30-day postoperative complications and mortality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
664
It 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).
It 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.
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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
Time frame: 36 months post-randomization
Length of colon resected
Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Time frame: 2 weeks post operation.
Length of small bowel resected
Limited to right hemicolectomy. Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Time frame: 2 weeks post operation.
Distance between tumor and closest arterial vascular division
Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Time frame: 2 weeks post operation.
Distance between nearest bowel wall and the same vascular division
Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Time frame: 2 weeks post operation.
Area of mesentery resected
Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Time frame: 2 weeks post operation.
Mesocolic grading
Follow the criteria described by Professor West's criteria (Lancet Oncol 2008,PMID: 18667357). This classification system includes three grades: Mesocolic plane, Intramesocolic plane, Muscularis propria plane.
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Time frame: 2 weeks post operation.
Number of lymph nodes harvested
Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Time frame: 2 weeks post operation.
Incidence of intraoperative complications
Intraoperative complications refer to accidents that occur during surgery. Complications may cause harm to the patient or threaten their life safety (such as iatrogenic intestinal injury, vascular injury or other organ injuries, severe bleeding, cardiovascular and cerebrovascular events or respiratory dysfunction that lead to the interruption of surgery, etc.). These events may result in the prolongation of the surgery, changes in the surgical method, unplanned medical interventions, or even endanger the patient's life. The study provides classifications and definitions of common complications. For complications not included in the classification table, refer to the Common Terminology Criteria for Adverse Events (CTCAE) V6.0.
Time frame: From the start of surgical skin incision to the completion of skin suturing.
Incidence 30-day postoperative complications
Postoperative complications refer to symptoms and signs diagnosed through imaging or clinical evaluation after surgery . The study provides classifications and definitions of common complications. For complications not included in the classification table, refer to the Common Terminology Criteria for Adverse Events (CTCAE) V6.0.
Time frame: From the completion of skin suturing to 30 days after surgery.