Comparing Long-Term Outcomes of Laparoscopic and Open Surgery for Colon Cancer Patients with High Visceral Fat

What this Trial Is About

Researchers are investigating whether there is a difference in long-term outcomes between laparoscopic surgery and open surgery for colon cancer patients who have visceral obesity. This condition presents challenges for laparoscopic surgery, which is generally less invasive and has similar survival rates to open surgery. Previous studies mainly involved lean patients and excluded those with higher body mass indexes, while this trial focuses on patients with a higher Body Roundness Index BRI 6 5.0 to better represent those with significant visceral fat. The study is a prospective, international, multicenter, randomized clinical trial. Participants will be randomly assigned to one of two surgical groups laparoscopic surgery or open surgery. Both groups will undergo surgery following the Complete Mesocolic Excision CME standard. Laparoscopic surgery involves inflating the abdomen and using small incisions with a camera and instruments, while open surgery involves a larger abdominal incision allowing direct manual access. After surgery, patients will be followed for five years to monitor outcomes. Participants will undergo several assessments, including blood tests, imaging scans, and pathological evaluations. Researchers will measure the primary outcome of three-year disease-free survival, along with secondary outcomes such as specimen quality, postoperative complications within 30 days, and mortality. Follow-up visits will monitor health status over five years to evaluate surgical effectiveness and safety in this specific patient population.

Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity