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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sigmoid Cancer, Colorectal Cancer

Intervention / Treatment
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* Procedure: Complete mesocolon excision
* Procedure: Conventional locoregional lymphadenectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial, single blind (the patient does not know the group to which it has been assigned) of patients undergoing laparoscopic sigmoid colon cancer resection. In all patients a lymphadenectomy with a high ligation of the Lower Mesenteric Artery will be performed. In patients in group 1A, lymphadenectomy will also include the lymphogranular tissue that accompanies the inferior mesenteric vein from its origin (complete mesocolon excision). In patients in group 1B, a conventional lymphadenectomy will be performed only from the origin of the inferior mesenteric artery without including the lymphatic tissue of the origin of the inferior mesenteric vein.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complete Mesocolon Excision<br>A high tie of the inferior mesenteric artery (IMA) should be attempted. The inferior mesenteric vein section at the Treitz angle should be performed. The lymphatic tissue that accompanies the inferior mesenteric vein should be added. | Procedure: Complete mesocolon excision<br>* 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)<br>|
| Active Comparator: Conventional Locoregional Lymphadenectomy<br>A high tie of the inferior mesenteric artery (IMA) should be attempted. Lymphadenectomy of the lymphatic tissue that accompanies the IMA will be performed. The inferior mesenteric vein section could be performed at the discretion of the surgeon. | Procedure: Conventional locoregional lymphadenectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence | To compare the tumor local recurrence rate between the two arms. | 5 years | 
| Survival | To compare the survival rate (deaths from cancer) between the two arms | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complete mesocolon excision, Colorectal cancer, Sigmoid cancer