Clinical Trial: Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)

Brief Summary: A randomized, controlled clinical trial comparing lymphadenectomy with extended inferior mesenteric artery ligation (complete mesocolon excision: which includes lymphoma tissue from the origin of the inferior mesenteric vein) with conventional locoregional lymphadenectomy in patients undergoing laparoscopic sigmoidectomy for sigmoid cancer.

Detailed Summary:
Sponsor: Pere Planellas Giné

Current Primary Outcome: Total number of lymph nodes and lymph node ratio. [ Time Frame: 30 days ]

To compare the total number of lymph nodes resected and the lymph node ratio (definded as ratio of lymph nodes with tumor metastasis to the total lymph nodes resected) between the two arms.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Local recurrence [ Time Frame: 5 years ]
    To compare the tumor local recurrence rate between the two arms.
  • Survival [ Time Frame: 5 years ]
    To compare the survival rate (deaths from cancer) between the two arms


Original Secondary Outcome: Same as current

Information By: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Dates:
Date Received: March 2, 2017
Date Started: July 2017
Date Completion: March 2023
Last Updated: March 13, 2017
Last Verified: March 2017