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

Pere Planellas Giné93 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Colorectal Cancer Sigmoid Cancer

Interventions

Complete mesocolon excisionPROCEDURE

Laparoscopic sigmoidectomy with lymphadenectomy of the lymphatic tissue that accompanies the inferior mesenteric vein and a high tie ligation of the inferior mesenteric artery (complete mesocolon excision)

Conventional locoregional lymphadenectomyPROCEDURE

Laparoscopic sigmoidectomy with lymphadenectomy of the lymphatic tissue that accompanies the inferior mesenteric artery and a high tie ligation of the inferior mesenteric artery with or without section of inferior mesenteric vein.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing programmed surgery for laparoscopic sigmoid colon cancer. * Age ≥ 18 years and \<80 years. * Histology of adenocarcinoma or adenoma without chemotherapy or neoadjuvant radiotherapy. * Any T, any N, M0. * Intention of resection R0. * Informed consent signed by the patient and the investigator. Exclusion Criteria: * Colorectal tumor with histology other than adenocarcinoma or adenoma. * Colon cancer located in the right colon, transverse, splenic or non-sigmoid left colon. * Metastatic disease (M1). * History of colorectal cancer surgery, different from a local excision. * Inflammatory bowel disease with anatomopathological confirmation. * Patients with psychiatric illness, addiction or any disorder that impedes the understanding of informed consent. * Inability to read or understand any of the languages of the informed consent (Catalan, Spanish). * Another synchronous malignant disease. * Emergency surgery.

Locations (1)

University Hospital Dr. Josep Trueta of Girona

Girona, Spain

Outcomes

Primary Outcomes

Total number of lymph nodes and lymph node ratio.

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

Time frame: 30 days

Secondary Outcomes

Local recurrence

To compare the tumor local recurrence rate between the two arms.

Time frame: 5 years

Survival

To compare the survival rate (deaths from cancer) between the two arms

Time frame: 5 years

Data from ClinicalTrials.gov

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