Actively Recruiting
Comparing Complete Mesocolic Excision with Standard Surgery for Right Colon Cancer in Adults
Led by University of Turin, Italy · Updated on 2022-11-14
416
Participants Needed
14
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a surgical approach called Complete Mesocolic Excision with Central Vascular Ligation CMECVL compared to standard right hemicolectomy in patients with malignant tumors located in the right or proximal transverse colon. This Italian randomized controlled trial focuses on patients with stage II-IV colon cancer and aims to determine differences in disease-free survival as the primary outcome. The study also looks at safety, oncologic results, surgical quality, and quality of life as secondary outcomes. Participants will be randomly assigned to one of two groups one undergoing the conventional non-CME right hemicolectomy and the other receiving the CMECVL procedure. The CMECVL technique involves removing lymphovascular tissue at the origin of supplying vessels and preserving the mesocolon as an intact envelope. Various surgical approaches, including open, laparoscopic, or robotic surgery, are allowed. Surgeons decide the type of anastomosis and drain placement. The trial plans to enroll 416 patients over one and a half years, with five years of postoperative follow-up. During the study, patients will be monitored at 1, 4, 12, 24, 36, and 60 months after surgery. Researchers will collect demographic, baseline, perioperative, and postoperative data, evaluating outcomes such as disease-free survival at three years, safety measures including operative time and complications, overall survival, and quality of life. The total study duration is expected to be six and a half years, providing both short- and long-term information on these surgical methods.
CONDITIONS
Brief Title
Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer
Research Team
M
Mario Solej, MD
H
Hogla Aridai Resendiz Aguilar, MD
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